CRNX Crinetics Pharmaceuticals Inc.

13.17
+0.69  (+6%)
Previous Close 12.48
Open 12.51
52 Week Low 10.63
52 Week High 26.67
Market Cap $433,076,775
Shares 32,883,582
Float 23,968,105
Enterprise Value $257,676,133
Volume 548,653
Av. Daily Volume 102,015
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Drug Pipeline

Drug Stage Notes
CRN00808 - ACROBAT EVOLVE
Acromegaly
Phase 2
Phase 2
Phase 2 data released October 26, 2020. Reduced sample size did not allow for meaningful statistical comparisons between groups.
CRN00808 Paltusotine (ACROBAT EDGE)
Acromegaly
Phase 2
Phase 2
Phase 2 trial met primary endpoint - October 26, 2020. Phase 3 trial to be initiated 1H 2021.
CRN04777
Congenital hyperinsulinism (HI)
Phase 1
Phase 1
Phase 1 trial to commence early 2021.

Latest News

  1. ACROBAT Edge Results Showed Maintenance of IGF-1 Suppression with Paltusotine After Switching from Depot Somatostatin Receptor Ligand Monotherapy  

    Paltusotine was observed to be well tolerated among the 60 participants in the ACROBAT Edge and Evolve Studies

    On Track to Initiate Phase 3 Paltusotine Program in 1H 2021

    SAN DIEGO, Oct. 26, 2020 (GLOBE NEWSWIRE) --  Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced positive topline results from the company's Phase 2 ACROBAT Edge and ACROBAT Evolve studies of paltusotine (formerly CRN00808), the company's…

    ACROBAT Edge Results Showed Maintenance of IGF-1 Suppression with Paltusotine After Switching from Depot Somatostatin Receptor Ligand Monotherapy  

    Paltusotine was observed to be well tolerated among the 60 participants in the ACROBAT Edge and Evolve Studies

    On Track to Initiate Phase 3 Paltusotine Program in 1H 2021

    SAN DIEGO, Oct. 26, 2020 (GLOBE NEWSWIRE) --  Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced positive topline results from the company's Phase 2 ACROBAT Edge and ACROBAT Evolve studies of paltusotine (formerly CRN00808), the company's lead candidate for the treatment of acromegaly. The Company will hold a conference call at 8:00 a.m. Eastern Time today to discuss these results. In addition, a Key Opinion Leader (KOL) call will be held on November 20th to discuss these results in the context of the current standard of care with clinical experts.

    The prespecified primary endpoint in Edge was achieved, showing that once daily oral paltusotine maintained insulin-like growth factor-1  (IGF-1) levels at Week 13 in acromegaly patients who were switched from an injected somatostatin receptor ligand  (SRL) depot of either octreotide or lanreotide monotherapy  [change in IGF-1 = -0.034  (-0.107, 0.107), median (IQR)]. There were 25 patients enrolled in this prespecified primary analysis population (Group 1). During the four-week washout period after the 13-week treatment period, Group 1 patients showed a meaningful  (>20%) and prompt  (within two weeks) rise in IGF-1 levels from baseline, which characterized the magnitude of therapeutic activity of oral paltusotine in acromegaly patients. Edge also enrolled an additional 22 patients into four different exploratory populations  (Groups 2-5). 

    Paltusotine was generally well tolerated among the 60 ACROBAT participants (including both Edge and Evolve), which is consistent with prior clinical findings in healthy volunteers. There were no discontinuations due to drug-related adverse events, no safety signals seen in clinical laboratory analyses, no treatment-related serious adverse events (SAEs), and no patients required rescue treatments with standard acromegaly medications during treatment. The most common treatment-emergent adverse events (>10%) included: headache, arthralgia, fatigue, peripheral swelling, paresthesia and hyperhidrosis.

    "These results from Edge and Evolve support the potential to effectively switch acromegaly patients from their current depot injections to a once-daily oral treatment while maintaining hormonal control," stated Alan Krasner M.D., Chief Medical Officer of Crinetics. "The heterogeneous nature of the ACROBAT patient population is representative of the real-world population, where acromegaly patients are prescribed a variety of treatments in an effort to control their IGF-1 levels, often unsuccessfully. The potential for once daily oral paltusotine to offer similar disease control provided by first-line injected depot SRLs gives us confidence to move into a Phase 3 program to further evaluate the efficacy and safety of paltusotine."

    Scott Struthers, Ph.D., founder and Chief Executive Officer of Crinetics, added, "Overall, we believe these findings support our thesis that once daily oral paltusotine has the potential to replace injected peptide depots for acromegaly therapy. We look forward to meeting with the FDA to share these results and finalize the protocol for our planned Phase 3 program, which remains on track to begin in the first half of 2021."

    Findings from ACROBAT Edge

    Edge enrolled a total of 47 patients with confirmed diagnoses of acromegaly at 45 clinical sites in 13 countries. The prespecified primary analysis population (Group 1) included 25 patients who were previously treated with SRL monotherapy (octreotide or lanreotide) and had a baseline IGF-1 of >1.0x the upper limit of normal (ULN) and <2.5x ULN. Groups 2-5 (n=22) were predefined as exploratory populations and are described in the table below.

    GroupPre-Trial TherapyBaseline IGF-1

    (x ULN)
    Total Enrolled
    1SRL monotherapy (octreotide or lanreotide)> 1.0 ≤ 2.525
    2SRL + cabergoline> 1.0 ≤ 2.510
    3SRL + cabergoline≤ 1.05
    4Pasireotide≤ 1.04
    5SRL + Pegvisomant≤ 1.03

    Three IGF-1 measurements were taken during a four- to six-week screening period, the average of which was defined as the "baseline" value. Following screening and four weeks after the last depot injection, each patient was treated for 13 weeks with paltusotine. All patients were started on 10 mg of paltusotine and then titrated up to 20, 30 and 40 mg at Weeks 4, 7 and 10, respectively, if the study drug was well tolerated and if the previous IGF-1 levels were >0.9x ULN at Weeks 2 and 5, and if IGF-1 levels were >1.0x ULN at Week 8. At the end of 13 weeks, 18 of the Group 1 patients who completed the dosing period were on 40 mg, two were on 30 mg, two were on 20 mg, and one was on 10 mg.

    The primary endpoint in the primary analysis population prespecified in the Statistical Analysis Plan (Group 1) showed that at the end of the 13-week treatment period, the median IGF-1 was 1.343, compared to the median IGF-1 of 1.335 at baseline (p>0.6 for change from baseline), indicating there was no statistically significant difference in IGF-1 control after patients had switched from pre-trial injected therapy to oral paltusotine monotherapy. Furthermore, the statistically significant rise in IGF-1 levels during the four-week washout period (p<0.0001) compared to the end of treatment time point at Week 13, shows the magnitude of the therapeutic activity of paltusotine in these patients and is shown in the table below. At every timepoint throughout the 13-week dose titration treatment period, median IGF-1 levels were maintained similar to baseline levels.

    Parameter (units)



    Baseline



    End of Treatment



    Withdrawal Period
    2 Weeks4 Weeks
    Number of patientsn=25n=25n=23n=22
    IGF-1 (xULN)    
    Mean (95% CI)1.337 (1.217, 1.456)1.327 (1.205, 1.449)1.983 (1.729, 2.237)2.031 (1.785, 2.277)
    Median (IQR)1.335 (1.078, 1.471)1.343 (1.169, 1.448)1.795 (1.512, 2.382)2.053 (1.689, 2.511)
     
    Change in IGF-1 (xULN)Change from BaselineChange from End of Treatment
    Mean (95%CI)-0.010 (-0.093, 0.074)0.614 (0.394, 0.834)0.676 (0.469, 0.882)
    Median (IQR)-0.034 (-0.107, 0.107)0.477 (0.181, 1.068)0.552 (0.408, 1.024)
    p-value>0.6<0.0001<0.0001

    Switching patients in the exploratory Edge populations in Groups 2 and 3 (n=15), who were treated with a combination of cabergoline and an SRL at baseline, to paltusotine monotherapy showed that cabergoline contributed to IGF-1 lowering. However, after withdrawal of paltusotine monotherapy in the washout period, it appeared that the magnitude of therapeutic activity of paltusotine was greater than that of cabergoline.

    Although the small sample sizes in Group 4 (n=4) and Group 5 (n=3) were too low to assess paltusotine's activity in the smaller patient populations represented by these groups, these data will contribute to the broader paltusotine safety database. Patients represented by Groups 2-5 will not be included in the Phase 3 program but are included in the safety analysis.

    Findings from ACROBAT Evolve

    Evolve was designed as a double-blind, placebo-controlled, randomized withdrawal study conducted at 44 clinical sites in 13 countries. As previously announced, the enrollment was terminated early, enabling data to be available for the end of Phase 2 regulatory interactions on the Edge study. The thirteen patients enrolled in the study with confirmed diagnoses of acromegaly whose levels of IGF-1 were biochemically controlled (<1.0x ULN) on standard-of-care SRL depot injections completed participation in the study. They were included in the safety analysis and provided additional response data at the low end of the dose range.

    All patients were switched to 10 mg of paltusotine once daily, four weeks after receiving the last injection of depot SRL during the screening period. At predetermined timepoints, IGF levels and tolerability were assessed and doses were increased in 10 mg increments as dictated by the protocol up to a maximum of 30 mg. After this dose titration phase, participants were randomized to receive paltusotine or placebo for four additional weeks if their week eight IGF-1 was <1.0x ULN. Prior to randomization, only three patients advanced to the 30 mg dose, six were on 20 mg and three on 10 mg (one patient discontinued prior to randomization). Seven patients met the criteria for randomization (n=3 paltusotine and n=4 placebo); the other five patients remained on paltusotine. As in Edge, paltusotine was withdrawn for four weeks following the conclusion of the 13-week treatment period.

    The reduced sample size did not allow for meaningful statistical comparisons between groups in the randomized withdrawal period. Data from these patients on lower doses of paltusotine were included in the post-hoc dose response analyses in combination with data from patients in the Edge study, most of whom received the higher doses.

    Dose Response Analyses

    Post-hoc analyses of patients in Edge (Group 1; n=25) and Evolve (n=13) were conducted in order to explore the effect of paltusotine dose on IGF-1 suppression. These analyses provided evidence of a dose response across the dose range of 10 to 40 mg. Dose-dependent results were observed when evaluating the effect on IGF-1 levels from: 1) switching from injectable SRL to paltusotine, and 2) withdrawing paltusotine during the washout phase. These data and ongoing exposure response analysis will inform the selection of doses to be included the Phase 3 program that will be finalized after consultation with the FDA.

    Patient Reported Outcome Measures

    Several different patient-reported outcome instruments were evaluated in the ACROBAT studies. Analyses of the performance of these tools are still being conducted, and Crinetics looks forward to presenting findings at an upcoming medical conference.

    Conference Call Information:

    Crinetics will hold a conference call and live audio webcast today, October 26, 2020 at 8:00 a.m. Eastern Time to discuss the topline results of the ACROBAT trials. To participate, please dial 877-407-0789 (domestic) or 201-689-8562 (international) and refer to conference ID 13712345. To access the webcast, please visit the Events page on the Crinetics website. The archived webcast will be available for 90 days.

    KOL Event:

    Crinetics will hold a KOL event via webcast on Thursday, November 20, 2020. A live webcast of the presentation will be accessible under Events in the Investors section of the company website at www.crinetics.com and will be archived there following the presentation for 30 days.

    About Paltusotine

    Paltusotine (formerly CRN00808) is an orally available nonpeptide biased agonist that is designed to be highly selective for the somatostatin receptor subtype 2. It was designed by the Crinetics discovery team to provide a once daily option for patients with acromegaly and neuroendocrine tumors that are currently treated by injected therapies that sell approximately $3.1 billion annually. Non-clinical chronic toxicology studies are complete and no dose limiting toxicity was identified at the maximum feasible doses in rats and dogs. Crinetics previously completed a Phase 1 trial that showed potent suppression of the growth hormone (GH) axis in healthy volunteers, which provided clinical proof-of-concept. In addition, the molecule's observed plasma half-life of ~2 days suggested the potential for paltusotine for once daily oral administration. A subsequent Phase 1 trial showed that paltusotine was 70% orally bioavailable.

    About Acromegaly

    Acromegaly is a serious disease generally caused by a benign growth hormone (GH) secreting tumor in the pituitary. Excess GH secretion causes excess secretion of IGF-1 from the liver, which causes bone and cartilage overgrowth, organ enlargement, and changes in glucose and lipid metabolism. The symptoms of acromegaly include abnormal growth of hands and feet and changes in shape of the bone and cartilage that result in alteration of facial features. Overgrowth of bone and cartilage and thickening of tissue leads to arthritis, carpal tunnel syndrome, joint aches, enlarged lips, nose and tongue, deepening of voice due to enlarged vocal cords, sleep apnea due to obstruction of airways and enlargement of heart, liver and other organs.

    Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients that are not candidates for surgery, or when surgery is unsuccessful in achieving treatment goals. Approximately 50% of patients with acromegaly prove to be candidates for pharmacological treatment. Long-acting SRLs are usually the initial pharmacologic treatment, however these drugs require monthly injections and are commonly associated with pain, injection site reactions, and increased burden in the lives of patients. Although over 90% of patients have demonstrable responses to SRLs (Annals of Internal Medicine. 1992; 117:711-718) only 20-40% of patients achieve normalization of IGF-1 (J Clin Endocrinol Metab 99: 791–799, 2014). Additional pharmacological treatment options include dopamine agonists or GH receptor antagonists which may be used in combination with SRLs.

    About Crinetics Pharmaceuticals

    Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company's lead product candidate, paltusotine (formerly CRN00808), is an oral selective nonpeptide somatostatin receptor type 2 biased agonist for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. Crinetics plans to advance paltusotine into a Phase 3 program in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with NETs in 2021. The company is also developing CRN04777, an oral nonpeptide somatostatin receptor type 5 (SST5) agonist for hyperinsulinism, as well as an oral nonpeptide ACTH antagonist for the treatment of Cushing's disease, congenital adrenal hyperplasia and other diseases of excess ACTH. All of the company's drug candidates are new chemical entities resulting from in-house drug discovery efforts and are wholly owned by the company. For more information, please visit www.crinetics.com.

    Forward-Looking Statements

    Crinetics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential benefits of paltusotine for acromegaly patients; the potential to initiate a Phase 3 program of paltusotine in acromegaly based on the Edge and Evolve topline results and the timing thereof; Crinetics' plans to meet with the FDA to finalize the protocol for a Phase 3 program for paltusotine; and the planned expansion of the paltusotine development program to include the treatment of carcinoid syndrome in patients with NETs and the expected timing thereof, including initiation of a Phase 2 trial in these patients. The inclusion of forward-looking statements should not be regarded as a representation by Crinetics that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Crinetics' business, including, without limitation: topline data that Crinetics reports is based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trials and such topline data may not accurately reflect the complete results of a clinical trial, and the FDA and other regulatory authorities may not agree with Crinetics' interpretation of such results; advancement of paltusotine into a Phase 3 program is dependent on and subject to the receipt of further feedback from the FDA; the COVID-19 pandemic may disrupt Crinetics' business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; the company's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics' clinical trials and nonclinical studies for paltusotine and its other product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the company's product candidates that may limit their development, regulatory approval and/or commercialization; Crinetics may use its capital resources sooner than it expects; and other risks described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Crinetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    Contacts:

    Marc Wilson

    Chief Financial Officer

     

    (858) 450-6464
    Investors / Media:

    Corey Davis

    Life Science Advisors

     

    212-915-2577
      
     Aline Sherwood

    Scienta Communications



    (312) 238-8957

    Primary Logo

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  2. SAN DIEGO, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced that the U.S. Food and Drug Administration ("FDA") has granted rare pediatric disease designation ("RPD") for CRN04777, an investigational, orally available, nonpeptide somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism (HI). Congenital HI is a devastating rare disease in which infants are born with life threatening hypoglycemia (low blood glucose) due to excess insulin secretion.

    "Congenital HI is a…

    SAN DIEGO, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced that the U.S. Food and Drug Administration ("FDA") has granted rare pediatric disease designation ("RPD") for CRN04777, an investigational, orally available, nonpeptide somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism (HI). Congenital HI is a devastating rare disease in which infants are born with life threatening hypoglycemia (low blood glucose) due to excess insulin secretion.

    "Congenital HI is a serious condition of neonates, infants, and children. Failure to recognize and effectively treat this disease can lead to seizures, permanent neurological sequelae, and even death," explained Christine Ferrara-Cook, M.D., Medical Director at Crinetics. "CRN04777 is the first oral, selective nonpeptide SST5 receptor agonist designed to reduce insulin secretion and is intended to be a universal treatment for all patients with congenital HI." Dr. Ferrara-Cook is a pediatric endocrinologist and key member of the CRN04777 development team with an expertise in congenital HI that she gained through a decade in medicine and life sciences drug development.

    A rare pediatric disease is defined by the Federal Food, Drug, and Cosmetic Act to include a serious or life-threatening disease, which primarily affects individuals aged from birth to 18 years and affects fewer than 200,000 people in the U.S. In an effort to address the challenges drug companies face when developing treatments for these unique patient populations, the FDA developed the Rare Pediatric Disease Priority Review Voucher ("PRV") Program. Under this program, companies are eligible to receive a priority review voucher following approval of a product with an RPD designation if the marketing application submitted for the product satisfies certain additional conditions*. If issued, a sponsor may redeem a PRV for priority review of a subsequent marketing application for a different product candidate, or the PRV could be sold or transferred to another sponsor.

    "We are encouraged by the positive and collaborative interaction we had with the FDA regarding the clinical development of CRN04777 for congenital HI," added Scott Struthers, Ph.D., founder and Chief Executive Officer of Crinetics. "The receipt of this RPD designation points to the seriousness of the disease for which there is an enormous need for new treatment options. Inspired by the bravery of the patients with congenital HI and their families, we are working diligently to ready CRN04777 for a Phase 1 clinical study in early 2021."

    About Congenital Hyperinsulinism

    Hyperinsulinism is a heterogeneous condition in which dangerously low blood sugar levels are caused by increased insulin secretion from pancreatic ß-cells. Congenital HI is a severe form of hyperinsulinism driven by genetic mutations in certain genes involved in regulating insulin secretion. The incidence of congenital HI is approximately 1 in 30,000 to 50,000 new births in the United States. While this is a rare disease, congenital HI is a leading cause of persistent hypoglycemia in infants and children. Early diagnosis is vital to prevent neurological complications due to recurrent low blood sugar, which can result in apnea, seizures, developmental delays, learning disabilities, epilepsy, and even death.

    About Crinetics Pharmaceuticals

    Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company's lead product candidate, paltusotine (formerly CRN00808), is an oral selective nonpeptide somatostatin receptor type 2 biased agonist undergoing two Phase 2 clinical trials for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. Crinetics plans to advance paltusotine into a Phase 3 trial in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with NETs in 2021. The company is also developing CRN04777, an oral nonpeptide somatostatin receptor type 5 (SST5) agonist for hyperinsulinism, as well as an oral nonpeptide ACTH antagonist for the treatment of Cushing's disease, congenital adrenal hyperplasia and other diseases of excess ACTH. All of the company's drug candidates are new chemical entities resulting from in-house drug discovery efforts and are wholly owned by the company. For more information, please visit www.crinetics.com.

    *NOTE: Unless modified by Congress, the RPD Priority Review Voucher Program is currently expected to expire on September 30, 2020. A drug that has been granted RPD designation prior to this date is still eligible to receive the PRV as long as it receives final FDA approval before September 30, 2022.

    Forward-Looking Statements

    Crinetics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: Crinetics' eligibility to receive a priority review voucher following approval of CRN04777 for the treatment of congenital HI; the potential of CRN04777 to have a meaningful impact on patient care; the potential to initiate Phase 1 trials of CRN04777 and the timing thereof; the potential of CRN04777 to be an effective treatment option for congenital HI patients; the potential for any of our ongoing clinical trials to show safety or efficacy; and the potential to initiate a pivotal Phase 3 trial of paltusotine in acromegaly or a Phase 2 trial for the treatment of carcinoid syndrome and the timing thereof. The inclusion of forward-looking statements should not be regarded as a representation by Crinetics that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Crinetics' business, including, without limitation: Crinetics may not meet the eligibility criteria for a priority review voucher; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; advancement of paltusotine into a Phase 3 trial for acromegaly or a Phase 2 trial for carcinoid syndrome and CRN04777 into a Phase 1 trial for congenital HI are dependent on and subject to the receipt of further feedback from the FDA and foreign regulatory agencies; the COVID-19 pandemic may disrupt Crinetics' business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; the company's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of the company's product candidates that may limit their development, regulatory approval and/or commercialization; and other risks described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Crinetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    Contacts:

    Marc Wilson

    Chief Financial Officer



    (858) 450-6464
    Media:

    Aline Sherwood

    Scienta Communications



    (312) 238-8957

    Primary Logo

    View Full Article Hide Full Article
  3. SAN DIEGO, Sept. 04, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced that a presentation on the company's orally administered, small molecule adrenocorticotropic hormone (ACTH) antagonist was selected for a late-breaking session at the virtual European Congress of Endocrinology (eECE) on September 8, 2020. In addition, a poster summarizing results from Phase 1 bioavailability studies of paltusotine (formerly CRN00808), the company's lead candidate for the treatment of acromegaly, will be available to congress attendees from…

    SAN DIEGO, Sept. 04, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced that a presentation on the company's orally administered, small molecule adrenocorticotropic hormone (ACTH) antagonist was selected for a late-breaking session at the virtual European Congress of Endocrinology (eECE) on September 8, 2020. In addition, a poster summarizing results from Phase 1 bioavailability studies of paltusotine (formerly CRN00808), the company's lead candidate for the treatment of acromegaly, will be available to congress attendees from September 5-9, 2020.

    Crinetics is developing an ACTH antagonist for the treatment of diseases associated with excess ACTH such as Cushing's disease and congenital adrenal hyperplasia (CAH). In the presentation at eECE, Crinetics will present data that one of a lead series of experimental ACTH antagonists reduced corticosterone levels and had a positive effect on adrenal gland size, morphology and function after seven days of repeat dosing in a rat model of ACTH excess. Based on these favorable preclinical in vivo results, Crinetics plans to advance its lead ACTH antagonist into Phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) studies in healthy volunteers in late 2020 or early 2021.

    "Our drug candidate is on track to be the first ACTH antagonist to enter clinical development for treatment of diseases driven by ACTH excess, including Cushing's Disease and CAH," explained Alan Krasner M.D., Chief Medical Officer of Crinetics. "An orally available, potent, nonpeptide drug could have a very meaningful impact in these patients for whom there are limited therapeutic options. We look forward to achieving the next milestone in this program by advancing our lead ACTH antagonist candidate into Phase 1."

    Separately, in a poster presentation at eECE, Crinetics will report results from a Phase 1 study showing that paltusotine provided a favorable mean oral bioavailability of 70%. In addition, no abundant circulating metabolites of paltusotine were identified. Adverse events associated with paltusotine were generally mild and transient and were consistent with those reported with other somatostatin agonists. The results of this study suggest that paltusotine exhibits excellent properties appropriate for chronic once-daily oral treatment of patients with acromegaly.

    In April 2020, Crinetics reported interim results from an exploratory analysis of the first 13 patients who entered the ACROBAT Edge Phase 2 trial on octreotide or lanreotide depot monotherapy, which showed that, as of the cutoff date, switching to once daily oral paltusotine maintained IGF-1 levels at those achieved with prior depot therapy. Paltusotine was well tolerated and the adverse events observed were similar to those of other somatostatin agonists. No discontinuations due to drug-related adverse events occurred, and the most common treatment-emergent adverse events (>10%) were headache, arthralgia, peripheral swelling, back pain and hyperhidrosis.

    Scott Struthers, Ph.D., founder and Chief Executive Officer of Crinetics, added, "We look forward to reporting topline results from the full ACROBAT dataset in the fourth quarter of this year. At that time, we anticipate having a more complete picture of paltusotine's pharmacokinetic and clinical profile, including the ability to maintain IGF-1 levels after switching patients from their prior somatostatin receptor ligand depot therapy."

    The poster and oral presentations will be made available on www.crinetics.com following the conclusion of the eECE meeting. Within the virtual ECE environment, they are:

    1)Effects of Nonpeptide Orally Bioavailable ACTH Antagonists on Adrenal Gland Size and Function in Rats: September 8, 2020 at 13:15 CET. Oral Communications 6 - Late breaking abstracts - Channel 3.
    2) Absolute Oral Bioavailability and Absorption, Metabolism, Excretion of [14C]-Labeled Paltusotine (CRN00808), an Orally Bioavailable, Nonpeptide, Selective, Somatostatin Receptor 2 (sst2) Biased Agonist for the Treatment of Acromegaly: September 5, 2020 from 01:00 - 19:05 CET. ePosters: Pituitary and Neuroendocrinology.

    In addition to the above eECE presentations, Crinetics will hold a Hub session titled: New Frontiers in Endocrine Research on September 9th at 08:00 CET during which Dr. Krasner will provide an overview of Crinetics and its pipeline programs. The eECE Hub sessions are open to all healthcare professionals who are registered for eECE 2020. More information may be found on the ECE website: ese-hormones.org/e-ece-2020.

    About Paltusotine

    Paltusotine (formerly CRN00808) is an orally available nonpeptide biased agonist that is designed to be highly selective for the somatostatin receptor type 2 (sst2). It was designed by the Crinetics discovery team to provide a once daily option for patients with acromegaly and neuroendocrine tumors that are currently treated by injected therapies that sell approximately $3.1 billion annually. Non-clinical chronic toxicology studies are complete and no dose limiting toxicity was identified at the maximum feasible doses in rats and dogs. Crinetics previously completed a Phase 1 trial that showed potent suppression of the growth hormone (GH) axis in healthy volunteers, which provided clinical proof-of-concept. In addition, the molecule's observed plasma half-life of ~2 days suggested the potential for paltusotine for once daily oral administration. A subsequent Phase 1 trial showed that paltusotine is 70% orally bioavailable.

    About Acromegaly

    Acromegaly is a serious disease generally caused by a benign growth hormone secreting tumor in the pituitary. Excess GH secretion causes excess secretion of insulin-like growth factor-1 (IGF-1) from the liver, which causes bone and cartilage overgrowth, organ enlargement, and changes in glucose and lipid metabolism. The symptoms of acromegaly include abnormal growth of hands and feet and changes in shape of the bone and cartilage that result in alteration of facial features. Overgrowth of bone and cartilage and thickening of tissue leads to arthritis, carpal tunnel syndrome, joint aches, enlarged lips, nose and tongue, deepening of voice due to enlarged vocal cords, sleep apnea due to obstruction of airways, and enlargement of heart, liver, and other organs.

    Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients that are not candidates for surgery, or when surgery is unsuccessful in achieving treatment goals. Approximately 50% of patients with acromegaly prove to be candidates for pharmacological treatment. Long-acting somatostatin receptor ligands (SRL) are usually the initial pharmacologic treatment, however these drugs require monthly injections and are commonly associated with pain, injection site reactions, and increased burden in the lives of patients. Although over 90% of patients have demonstrable responses to SRLs (Annals of Internal Medicine. 1992; 117:711-718) only 20-40% of patients achieve normalization of IGF-1 (J Clin Endocrinol Metab 99: 791–799, 2014). Additional pharmacological treatment options include dopamine agonists or GH receptor antagonists which may be used in combination with SRLs.

    About Cushing's Disease and Congenital Adrenal Hyperplasia

    Cushing's Disease is an orphan indication with a prevalence of approximately 12,000 patients in the United States. It presents much more commonly in women, and usually between 30 and 50 years of age. Cushing's disease often takes many years to diagnose and may well be under-diagnosed in the general population as many of its symptoms such as lethargy, depression, obesity, hypertension, hirsutism and menstrual irregularity can be incorrectly attributed to other more common disorders.

    CAH encompasses a set of disorders that are caused by genetic mutations that result in impaired cortisol synthesis. This lack of cortisol leads to a breakdown of feedback mechanisms and results in persistently high levels of ACTH, which in turn causes overstimulation of the adrenal cortex. The resulting adrenal hyperplasia and over-secretion of other steroids (particularly androgens) and steroid precursors can lead to a variety of adverse effects including atypical genital development, early puberty, abnormal growth, and infertility. CAH occurs in 1 in 13,000 to 1 in 15,000 live births.

    About Crinetics Pharmaceuticals

    Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company's lead product candidate, paltusotine (formerly CRN00808), is an oral selective nonpeptide somatostatin receptor type 2 biased agonist undergoing two Phase 2 clinical trials for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. Crinetics plans to advance paltusotine into a Phase 3 trial in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with NETs in 2021. The company is also developing an oral nonpeptide somatostatin receptor type 5 (sst5) agonist for hyperinsulinism, as well as an oral nonpeptide ACTH antagonist for the treatment of Cushing's disease, congenital adrenal hyperplasia and other diseases of excess ACTH. All of the company's drug candidates are new chemical entities resulting from in-house drug discovery efforts and are wholly owned by the company. For more information, please visit www.crinetics.com.

    Forward-Looking Statements

    Crinetics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential of Crinetics' ACTH antagonist to have a meaningful impact on patient care; the potential to initiate Phase 1 trials of Crinetics' lead ACTH antagonist and the timing thereof; the potential of paltusotine to be an effective treatment option for acromegaly patients; the potential for interim data results to be consistent with final results, once available; the potential for any of our ongoing clinical trials to show safety or efficacy; the potential to initiate a pivotal Phase 3 trial of paltusotine in acromegaly and the timing thereof; and the anticipated timing of topline data for the ACROBAT Phase 2 trials. The inclusion of forward-looking statements should not be regarded as a representation by Crinetics that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Crinetics' business, including, without limitation: the risk that interim results of a clinical trial do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; advancement of paltusotine into a Phase 3 trial and Crinetics' lead ACTH antagonist into Phase 1 trials are dependent on and subject to the receipt of further feedback from the FDA; the COVID-19 pandemic may disrupt Crinetics' business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; the company's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics' clinical trials and nonclinical studies for paltusotine, its ACTH antagonist and its other product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the company's product candidates that may limit their development, regulatory approval and/or commercialization; Crinetics may use its capital resources sooner than it expects; and other risks described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Crinetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    Contacts:Media:
    Marc WilsonAline Sherwood
    Chief Financial OfficerScienta Communications
    (858) 450-6464(312) 238-8957

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  4. SAN DIEGO, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals (NASDAQ:CRNX), today announced that management will participate in the following conferences in the month of September and invites investors to participate by webcast. Please see additional details below:

    Baird Global Healthcare Conference
      Date:   Wednesday, September 9th 2020    
      Time:   12:50 pm Eastern Time    
      Presenter:   Scott Struthers, Founder & CEO    
           
    H.C. Wainwright: 22nd Annual Global Investment Conference    
      Date:   Monday, September 14th 2020    
      Time:   10:30 am Eastern Time    
      Presenter:   Scott Struthers, Founder & CEO    
           
    Cantor Fitzgerald Global Healthcare Conference    
      Date:   Tuesday, September 15th 2020    
      Time:   2:00

    SAN DIEGO, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals (NASDAQ:CRNX), today announced that management will participate in the following conferences in the month of September and invites investors to participate by webcast. Please see additional details below:

    Baird Global Healthcare Conference
      Date:   Wednesday, September 9th 2020    
      Time:   12:50 pm Eastern Time    
      Presenter:   Scott Struthers, Founder & CEO    
           
    H.C. Wainwright: 22nd Annual Global Investment Conference    
      Date:   Monday, September 14th 2020    
      Time:   10:30 am Eastern Time    
      Presenter:   Scott Struthers, Founder & CEO    
           
    Cantor Fitzgerald Global Healthcare Conference    
      Date:   Tuesday, September 15th 2020    
      Time:   2:00 pm Eastern Time    
      Presenter:   Scott Struthers, Founder & CEO    

    Webcast Links:

    Links to the webcasts along with a replay of the webcasts will be accessible on the Events & Presentations page in the Investors section on the Company's website at www.crinetics.com.  

    About Crinetics Pharmaceuticals

    Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company's lead product candidate, paltusotine (formerly CRN00808), is an oral selective nonpeptide somatostatin receptor type 2 biased agonist undergoing two Phase 2 clinical trials for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. Crinetics plans to advance paltusotine into a Phase 3 trial in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with NETs in 2021. The company is also developing an oral nonpeptide somatostatin receptor type 5 (sst5) agonist for hyperinsulinism, as well as an oral nonpeptide ACTH antagonist for the treatment of Cushing's disease, congenital adrenal hyperplasia and other diseases of excess ACTH. All of the company's drug candidates are new chemical entities resulting from in-house drug discovery efforts and are wholly owned by the company. For more information, please visit www.crinetics.com.

               
    Contacts:           Media:
    Marc Wilson           Aline Sherwood
    Chief Financial Officer           Scienta Communications
              
    (858) 450-6464           (312) 238-8957



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  5. SAN DIEGO, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced the appointment of Camille L. Bedrosian, M.D. as an independent member of its board of directors. Dr. Bedrosian brings over 25 years of experience leading drug development efforts for rare disease products and building successful medical affairs and clinical development teams.

    "Dr. Bedrosian's experience in rare disease drug development will be an asset to Crinetics as we advance our pipeline," said Scott Struthers, Ph.D., Founder and Chief Executive Officer…

    SAN DIEGO, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced the appointment of Camille L. Bedrosian, M.D. as an independent member of its board of directors. Dr. Bedrosian brings over 25 years of experience leading drug development efforts for rare disease products and building successful medical affairs and clinical development teams.

    "Dr. Bedrosian's experience in rare disease drug development will be an asset to Crinetics as we advance our pipeline," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Her experience navigating the global regulatory landscape and understanding of the unique challenges that rare disease therapeutics face will be valuable as we continue our evolution into a commercial company."

    Dr. Bedrosian currently serves as Executive Vice President and Chief Medical Officer of Ultragenyx Pharmaceutical Inc. where she oversees global development functions including medical affairs, clinical development, clinical operations, regulatory affairs, patient advocacy and engagement, biometrics, and drug safety/pharmacovigilance. In this position, she is responsible for providing strategic leadership across clinical development and translational research programs. Prior to Ultragenyx, Dr. Bedrosian held executive-level positions in global development at Alexion Pharmaceuticals, Inc. and ARIAD Pharmaceuticals, Inc. Earlier in her career, Dr. Bedrosian served in the clinical research and development department of Genetics Institute, Inc. (acquired by Wyeth Inc., now part of Pfizer Inc.), where she assumed roles of increasing responsibility, eventually overseeing the company's hemophilia therapeutic area. Dr. Bedrosian earned her medical degree from Harvard Medical School, a Master of Science degree from MIT, and completed a residency and fellowship at Duke University School of Medicine. She currently serves as a Member of the MIT Corporation Visiting Committee for the department of biology.

    Dr. Bedrosian added, "I am impressed with the strong science at the core of Crinetics' business and am looking forward to working with the team to implement innovative approaches to help expedite the development of the company's pipeline of rare disease therapeutics."

    About Crinetics Pharmaceuticals

    Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company's lead product candidate, paltusotine (formerly CRN00808), is an oral, selective nonpeptide somatostatin receptor type 2 biased agonist undergoing two Phase 2 clinical trials for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. Crinetics plans to advance paltusotine into a Phase 3 trial in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors in 2021. The company is also developing an oral nonpeptide somatostatin receptor type 5 agonist for hyperinsulinism, as well as an oral nonpeptide ACTH antagonist for the treatment of Cushing's disease, congenital adrenal hyperplasia and other diseases of excess ACTH. All of the company's drug candidates are new chemical entities resulting from in-house drug discovery efforts and are wholly owned by the company. For more information, please visit www.crinetics.com.

    Contacts

    Investors:

    Marc Wilson

    Chief Financial Officer



    (858) 450-6464

    Media:

    Aline Sherwood

    Scienta Communications



    (312) 238-8957

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