PLRX Pliant Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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PLN-74809
Primary sclerosing cholangitis
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Phase 2a
Phase 2a
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Phase 2a trial to complete enrollment 1H 2022.
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PLN-74809
Idiopathic pulmonary fibrosis
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Phase 2a
Phase 2a
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Phase 2a PET positive interim data results released September 7, 2021.
|
|
PLN-1474
Liver fibrosis associated with NASH
|
Phase 1
Phase 1
|
Phase 1 trial has completed - well tolerated with no dose- or treatment-limiting toxicities or severe/serious adverse events observed.
|
Latest News
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SOUTH SAN FRANCISCO, Calif., Oct. 07, 2021 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced that Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will participate in a virtual fireside chat as part of the Piper Sandler Lung Day on Friday, October 15, 2021, at 11:00 a.m. ET.
A replay of the Piper Sandler virtual fireside chat will be available on the Events & Presentations page of Pliant's website following the conclusion of the event for 90 days.
About Pliant Therapeutics, Inc.
Pliant is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC. Pliant is currently recruiting Phase 2a trials of PLN-74809 in the lead indications of IPF and PSC. Pliant has also developed PLN-1474, a small-molecule selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has transferred to Novartis pursuant to its development partnership. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant, visit www.pliantrx.com and follow us on Twitter, LinkedIn, Facebook, and YouTube.
Investor and Media Contact:Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
ir@pliantrx.com
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- Single dose administration of PLN-74809 achieved αvβ6 target engagement up to 98% in the lungs of IPF patients
- All doses achieved target engagement above the threshold for predicted anti-fibrotic activity, with an observed dose-response relationship
- PLN-74809 reached highly fibrotic regions of the lung and was bound to αvβ6 in IPF patients
- Data provide insight into potential anti-fibrotic activity of PLN-74809 at the doses being evaluated in the ongoing Phase 2a INTEGRIS-IPF trial- Company to host conference call and webcast today at 8:00 a.m. ET
SOUTH SAN FRANCISCO, Calif., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced positive interim results from a Phase 2a positron emission tomography (PET) imaging-based clinical trial of PLN-74809, an oral small molecule dual selective inhibitor of αvβ6/αvβ1, in patients with idiopathic pulmonary fibrosis (IPF). Across four dose levels, all patients achieved greater than 50% target engagement after a single dose of PLN-74809. Target engagement of 50% was previously established in a Phase 1b trial as the threshold for predicted clinical anti-fibrotic effect. In addition, there was a dose- and plasma concentration-dependent response with the two highest doses approaching target saturation.
"We believe the high target engagement levels seen after the administration of just a single dose illustrate the potential of PLN-74809 to show a potent anti-fibrotic effect in our longer-term clinical trials," said Éric Lefebvre, M.D., Chief Medical Officer of Pliant Therapeutics. "Furthermore, these data represent a significant step forward in our understanding of the potential anti-fibrotic activity of PLN-74809 and support the selected doses in our ongoing 12-week Phase 2a INTEGRIS-IPF trial."
The ongoing Phase 2a open-label PET imaging clinical trial is designed to evaluate αvβ6 target engagement levels achieved by PLN-74809 when administered across single-doses of 60 mg, 120 mg, 240 mg or 320 mg in IPF patients. The trial is also evaluating safety, tolerability and pharmacokinetics. Patients undergo a PET scan prior to dosing and at four hours post-dose to evaluate target αvβ6 specific engagement. Images are analyzed for regions of high fibrotic activity, which are then evaluated for target engagement. Following completion of a standard washout period, patients may consent to receive a second dose of PLN-74809 at a different dose level followed by a second post-dose PET scan.
As fibrosis is a chronic disease, proof-of-efficacy in human trials is expensive and takes years to complete. Pliant utilizes pharmacodynamic biomarkers and advanced imaging techniques, including PET, to evaluate target engagement by our product candidates over relatively short time periods and de-risk Pliant's programs by designing clinical trials that allow the Company to show proof-of-mechanism in advance of clinical efficacy data.
Interim Phase 2a PET Clinical Trial ResultsFour IPF patients were administered six single doses of PLN-74809 across 60 mg, 120 mg, 240 mg or 320 mg, generating a total of six post-dose scans.
PLN-74809 Demonstrated Lung Penetration, with Greater than 50% Target Engagement Achieved in the Lungs of All IPF Patients Across All Dose Cohorts
- Up to 98% target engagement of PLN-74809 achieved
- Greater than 50% target engagement of PLN-74809 achieved across all doses
Dose and Plasma Concentration Response Established
- PLN-74809 achieved a dose response across all single-doses from 60 mg to 320 mg
- Suggests target engagement levels along the entire exposure curve of PLN-74809
- Supports potential anti-fibrotic activity of PLN-74809 at the doses being evaluated in the ongoing Phase 2a INTEGRIS-IPF trial
PLN-74809 Well-Tolerated Across All Doses
- No serious adverse events reported
Conference Call and Webcast
Pliant will host a conference call and webcast today at 8:00 a.m. ET to discuss this update. The webcast will be available in the Events & Presentations section of Pliant's website. This update can also be accessed by dialing (833) 519-1340 (United States and Canada) or (914) 800-3902 (international) and providing the passcode 6186023. An archived reply of the webcast will be available on Pliant's website for 90 days following the event.About Pliant Therapeutics, Inc.
Pliant is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrotic and related diseases. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of αvß6 and αvß1 integrins that is in development for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC. Pliant is currently recruiting for Phase 2a trials of PLN-74809 in the lead indications of IPF and PSC. Pliant has also developed PLN-1474, a small-molecule selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has transferred to Novartis pursuant to its development partnership. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant, visit www.pliantrx.com and follow us on Twitter, LinkedIn, Facebook, and YouTube.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those regarding the pharmacodynamics and therapeutic potential of PLN-74809, our plans for the future development of PLN-74809, the potential of our Phase 2a PET trial to predict future clinical outcomes and the potential for the preliminary results of this trial to predict future results. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant Therapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to the development and commercialization of our product candidates, including any delays in our ongoing or planned preclinical or clinical trials, the ongoing nature of our Phase 2a PET trial and the possibility that the preliminary data will not be predictive of full data from this trial, the possibility that results from this trial will not be predictive of future clinical outcomes, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and our ability to obtain and maintain intellectual property protection for our product candidates. These and additional risks are discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K filed with the SEC on March 16, 2021, as updated by our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, each available on the SEC's website at www.sec.gov. Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events, or otherwise.
Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
ir@pliantrx.com
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SOUTH SAN FRANCISCO, Calif., Sept. 03, 2021 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced that the Company plans to issue a pre-market press release and conduct a conference call and webcast on Tuesday, September 7, 2021, to discuss interim clinical data from an ongoing Phase 2a positron emission tomography (PET) imaging trial of PLN-74809 in patients with idiopathic pulmonary fibrosis (IPF).
The Company will host a conference call and webcast at 8:00 a.m. ET on Tuesday, September 7th to discuss this update. The link to the webcast of the conference call will be posted in the Events & Presentations section of the Company's website. The conference call may also be accessed by dialing (833) 519-1340 (domestic) or (914) 800-3902 (international) five minutes prior to the start of the call and providing the passcode 6186023. An archived replay will be accessible for 90 days following the event.
About Pliant Therapeutics, Inc.
Pliant is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrotic and related diseases. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of αvß6 and αvß1 integrins that is in development for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC. Pliant is currently recruiting for Phase 2a trials of PLN-74809 in the lead indications of IPF and PSC. Pliant has also developed PLN-1474, a small-molecule selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has transferred to Novartis pursuant to its development partnership. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant, visit www.pliantrx.com and follow us on Twitter, LinkedIn, Facebook, and YouTube.
Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
ir@pliantrx.com
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SOUTH SAN FRANCISCO, Calif., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced participation in the following investor conferences:
- Citi 16th Annual BioPharma Virtual Conference – Pliant's senior management team will participate in one-on-one meetings with members of the investment community September 8 - 9, 2021
- Cantor 2021 Virtual Global Healthcare Conference – Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will present on Wednesday, September 29, 2021, at 2:40 p.m. ET / 11:40 a.m. PT and, along with members of Pliant's senior management team, will participate in one-on-one meetings with members of the investment community
The webcast replay of the Cantor conference presentation will be archived for 90 days following the conclusion of the event.
About Pliant Therapeutics, Inc.
Pliant is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC. Pliant is currently recruiting Phase 2a trials of PLN-74809 in the lead indications of IPF and PSC. Pliant has also developed PLN-1474, a small-molecule selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has transferred to Novartis pursuant to its development partnership. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant, visit www.pliantrx.com and follow us on Twitter, LinkedIn, Facebook, and YouTube.
Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
ir@pliantrx.com
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- SAD cohorts up to 640 mg and MAD cohorts up to 320 mg completed in extended Phase 1a trial of PLN-74809
in healthy volunteers with no safety concerns identified- PLN-74809 Phase 2a 12-week trials in IPF and PSC currently on track to complete enrollment
by the end of 2021 and first half of 2022, respectively- Analysis of PLN-74809 Phase 2a PET images underway, including a 320 mg cohort,
with preliminary data anticipated upon analysis completionSOUTH SAN FRANCISCO, Calif., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (NASDAQ:PLRX) ("the Company"), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today provided a corporate update and reported second quarter 2021 financial results.
"Driven by our progress throughout the second quarter, enrollment continues to be on track for our Phase 2a trials of PLN-74809 in IPF and PSC with strong advancement in our development stage oncology and DMD programs," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "PLN-74809 continues to demonstrate a favorable safety profile as additional dose cohorts from the single and multiple ascending dose Phase 1a trial show PLN-74809 to be generally well tolerated at all dose levels tested, with a predictable pharmacokinetic profile similar to previous dose cohorts."Second Quarter and Recent Highlights
- Single ascending dose (SAD) cohorts up to 640mg and multiple ascending dose (MAD) cohorts up to 320mg completed in extended Phase 1a dose escalation trial of PLN-74809 in healthy volunteers. PLN-74809 has completed dosing of additional SAD cohorts of up to 640 mg and MAD cohorts of up to 320 mg once daily dose in an extended dose escalation trial. The pharmacokinetic profile remains generally dose proportional with PLN-74809 continuing to be generally well tolerated, with no severe adverse events or serious adverse events reported.
- Enrollment on track for PLN-74809 Phase 2a trial in idiopathic pulmonary fibrosis (IPF). INTEGRIS-IPF is a 12-week randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of PLN-74809 in IPF patients. This trial is evaluating exploratory endpoints including quantitative lung fibrosis score, or QLF, imaging as well as pulmonary function tests. Enrollment is currently on track to be completed by the end of 2021.
- Enrollment on track for PLN-74809 Phase 2a trial in primary sclerosing cholangitis (PSC). INTEGRIS-PSC is a 12-week randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of PLN-74809 in PSC patients. The trial is evaluating exploratory endpoints including fibrosis biomarkers such as Pro-C3 and ELF, changes in ALP, and liver imaging. Enrollment is currently on track to be completed in the first half of 2022.
- Image analysis from PLN-74809 Phase 2a positron emission tomography (PET) trial underway, including addition of a 320 mg cohort, with preliminary data anticipated upon completion of the analysis. This open-label, dose ranging trial is evaluating target receptor occupancy levels of PLN-74809 in the lungs of IPF patients across ascending single-dose cohorts, utilizing a PET tracer of the integrin αvβ6. The Company recently amended the protocol to increase the maximum dose to 320 mg. In the second quarter, the first patients were dosed in this cohort.
- Preclinical stage integrin-based programs continue to progress. The Company's early-stage programs targeting oncology and muscular dystrophies continue to advance toward the clinic. The oncology program is focused on increasing tumor checkpoint sensitivity through small molecule inhibition of αvβ8. The muscular dystrophy program is focused on improving muscle function through activation of an integrin compensatory mechanism with a monoclonal antibody.
- Resources redeployed in support of ongoing PLN-74809 Phase 2a trials in IPF and PSC. Despite the rise of recently identified COVID-19 variants, the broad availability of vaccines, as well as the increased and successful measures taken over the past nine months to contain the virus have resulted in a dramatic decrease in the number of severe and critical COVID-19 patients with acute respiratory distress syndrome (ARDS). Given the declining number of addressable patients, the Company has discontinued enrollment in the PLN-74809 Phase 2a COVID-19-related ARDS trial allowing for resources to be directed toward our lead indications.
COVID-19 Preparedness
The Company continues to develop and maintain policies and procedures to enable us to operate safely and productively during the COVID-19 pandemic. The Company has experienced delays in clinical trial operations which have impacted and may further impact the expected timing of data readouts. The Company continues to work closely with clinical sites to continue site initiation and operation activities in compliance with study protocols while observing government and institutional guidelines.Second Quarter 2021 Financial Results
- Research and development expenses were $19.2 million, as compared to $17.5 million for the prior-year quarter. The increase was due primarily to employee related expenses and higher costs related to the advancement of several programs and ongoing Phase 1/2 clinical trials.
- General and administrative expenses were $5.5 million, as compared to $3.0 million for the prior-year quarter. The increase was due to higher personnel-related and professional services expenses.
- Net loss of $22.8 million as compared to $17.0 million for the prior-year quarter due an overall increase in expense associated with our research and development programs as well as personnel-related costs.
- As of June 30, 2021, the Company had cash, cash equivalents and short-term investments of $244.0 million. The Company believes it has sufficient funds to meet its operating and capital requirements into 2023.
About Pliant Therapeutics, Inc.
Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant's lead product candidate, PLN-74809, is an oral small molecule dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC. Pliant is currently recruiting Phase 2a trials of PLN-74809 in the lead indications of IPF, PSC. Pliant has also developed PLN-1474, a small molecule selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has transferred to Novartis pursuant to our development partnership. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant Therapeutics, visit www.pliantrx.com and follow us on Twitter, LinkedIn, Facebook and YouTube.Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those regarding the anticipated progress of our clinical trials and timing of enrollment and data disclosures, the potential future impact of the COVID-19 pandemic and expectations regarding how far into the future our cash on hand will fund our operating and capital requirements. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant Therapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to the development and commercialization of our product candidates, including any delays in our ongoing or planned preclinical or clinical trials, , the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and our ability to obtain and maintain intellectual property protection for our product candidates. These and additional risks are discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K filed with the SEC on March 16, 2021, as updated by our Quarterly Report on Form 10-Q filed with the SEC on May 10, 2021 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, which we are filing with the SEC today, each available on the SEC's website at www.sec.gov. Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
IR@pliantrx.comPliant Therapeutics, Inc.
Condensed Statements of Operations
(Unaudited)
(In thousands, except number of shares and per share amounts)Three Months Ended
June 30,2021 2020 Revenue — related party $ 1,789 $ 3,600 Operating expenses: Research and development (19,218 ) (17,536 ) General and administrative (5,475 ) (3,040 ) Total operating expenses (24,693 ) (20,576 ) Loss from operations (22,904 ) (16,976 ) Interest and other income (expense), net 73 (25 ) Net income loss $ (22,831 ) $ (17,001 ) Less: Undistributed earnings to preferred shareholders — — Net loss attributable to common stockholders $ (22,831 ) $ (17,001 ) Net loss per share, attributable to common stockholders: Basic $ (0.64 ) $ (1.39 ) Diluted $ (0.64 ) $ (1.39 ) Shares used in computing net loss per share attributable to common stockholders: Basic 35,746,922 12,253,943 Diluted 35,746,922 12,253,943 Comprehensive income loss: Net loss $ (22,831 ) $ (17,001 ) Net unrealized loss on short-term investments $ (12 ) $ (89 ) Total other comprehensive loss (12 ) (89 ) Comprehensive loss $ (22,843 ) $ (17,090 ) Pliant Therapeutics, Inc.
Condensed Balance Sheets
(Unaudited)
(In thousands)June 30,
2021December 31,
2020Assets Current assets Cash and cash equivalents $ 35,193 $ 50,882 Short-term investments 208,788 226,012 Accounts receivable 1,830 9,279 Tax credit receivable 83 83 Prepaid expenses and other current assets 4,825 4,498 Total current assets 250,719 290,754 Property and equipment, net 4,367 4,321 Other non-current assets 630 451 Total assets $ 255,716 $ 295,526 Liabilities and Stockholders' Equity Current liabilities Accounts payable $ 2,764 $ 2,023 Accrued liabilities 8,168 9,576 Total current liabilities 10,932 11,599 Other long-term liabilities 804 866 Total liabilities 11,736 12,465 Stockholders' equity Common stock 3 3 Additional paid-in capital 407,522 400,918 Accumulated deficit (163,515 ) (117,828 ) Accumulated other comprehensive loss (30 ) (32 ) Total stockholders' equity 243,980 283,061 Total liabilities and stockholders' equity $ 255,716 $ 295,526 
- Single ascending dose (SAD) cohorts up to 640mg and multiple ascending dose (MAD) cohorts up to 320mg completed in extended Phase 1a dose escalation trial of PLN-74809 in healthy volunteers. PLN-74809 has completed dosing of additional SAD cohorts of up to 640 mg and MAD cohorts of up to 320 mg once daily dose in an extended dose escalation trial. The pharmacokinetic profile remains generally dose proportional with PLN-74809 continuing to be generally well tolerated, with no severe adverse events or serious adverse events reported.