ALNA Allena Pharmaceuticals Inc.

0.97
+0.01  (+1%)
Previous Close 0.96
Open 0.98
52 Week Low 0.75
52 Week High 2.78
Market Cap $77,736,506
Shares 80,140,728
Float 76,191,870
Enterprise Value $61,160,732
Volume 1,498,181
Av. Daily Volume 3,487,164
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
ALLN-346
Hyperuricemia
Phase 2a
Phase 2a
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Reloxaliase (ALLN-177) - (URIROX-2)
Enteric Hyperoxaluria
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
Reloxaliase ALLN-177 (URIROX-1)
Enteric Hyperoxaluria
Phase 3
Phase 3
Phase 3 trial met primary endpoint, key secondary endpoint missed - November 7, 2019.
Reloxaliase ALLN-177 (Study 206)
Primary hyperoxaluria
Phase 2
Phase 2
Phase 2 presentation at ASN November 8, 2019.

Latest News

  1. NEWTON, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to-treat metabolic diseases, today announced that company management will virtually participate in H.C. Wainwright's 23rd Annual Global Investment Conference, being held September 13th – 15th, 2021.

    Louis Brenner, M.D., Allena's President and Chief Executive Officer, will virtually participate in a fireside chat at the conference. The pre-recorded discussion will be available on demand beginning 7:00 a.m. ET on September 13th. A recording can also be accessed for 90 days at…

    NEWTON, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to-treat metabolic diseases, today announced that company management will virtually participate in H.C. Wainwright's 23rd Annual Global Investment Conference, being held September 13th – 15th, 2021.

    Louis Brenner, M.D., Allena's President and Chief Executive Officer, will virtually participate in a fireside chat at the conference. The pre-recorded discussion will be available on demand beginning 7:00 a.m. ET on September 13th. A recording can also be accessed for 90 days at the link below or via the Allena Pharmaceuticals website within the Investors/Events and Presentations section.

    Please see details for the session below:

    Date:7:00 a.m. ET
    Time:Monday, September 13th, 2021
    Webcast:https://journey.ct.events/view/f1d0178c-8b66-4f9b-bbb4-f26ad0dc2801

    Management will also be available for 1x1 meetings. If you would like to request a meeting, please email meetings@hcwco.com.

    About Allena Pharmaceuticals



    Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to-treat metabolic diseases. Allena's lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with a Phase 1 multiple-ascending dose study recently completed and a Phase 2a program recently initiated.

    Investor Contact

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    arr@lifesciadvisors.com

    Media Contact

    Adam Daley

    Berry & Company Public Relations

    212-253-8881

    adaley@berrypr.com 



    Primary Logo

    View Full Article Hide Full Article
    • ALLN-346 well-tolerated in recently completed Phase 1b study; first patients dosed in Phase 2a program for gout and chronic kidney disease; initial data expected in Q4 2021
    • June KOL webinar highlighted the unmet need in gout and potential for ALLN-346
    • Updated plan and timing for first interim analysis of Phase 3 URIROX-2 clinical trial of reloxaliase announced in July
    • Registered direct offering completed in July with gross proceeds of $28.0 million

    NEWTON, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA) ("Allena" or the "Company"), a late-stage biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to-treat…

    • ALLN-346 well-tolerated in recently completed Phase 1b study; first patients dosed in Phase 2a program for gout and chronic kidney disease; initial data expected in Q4 2021
    • June KOL webinar highlighted the unmet need in gout and potential for ALLN-346

    • Updated plan and timing for first interim analysis of Phase 3 URIROX-2 clinical trial of reloxaliase announced in July

    • Registered direct offering completed in July with gross proceeds of $28.0 million

    NEWTON, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA) ("Allena" or the "Company"), a late-stage biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to-treat metabolic diseases, today reported financial results for the second quarter ended June 30, 2021 and highlighted recent corporate progress.

    "This is an exciting time to advance our first-in-class, novel oral biologic platform," commented Louis Brenner, M.D., President and Chief Executive Officer of Allena. "We have continued to progress our two clinical programs with the goal of addressing therapeutic needs for patients with rare and severe metabolic conditions for which current treatment options are limited. For our reloxaliase program, we recently announced that we expect to conduct the first interim analysis early next year for patients enrolled in URIROX-2 through November of this year. We believe that this will provide meaningful and timely feedback for the conduct and ultimate completion of the adaptive design trial in patients with enteric hyperoxaluria."

    Dr. Brenner continued, "In addition, after successfully completing two Phase 1 safety studies, we are focused on advancing ALLN-346 through Phase 2a studies as a potential treatment for patients with gout in the setting of chronic kidney disease. We expect to accelerate the development of ALLN-346, which has the potential to address an unmet need for gout patients as an alternative to currently available agents that are either dose-limited or contraindicated in patients with gout and chronic kidney disease due to safety and tolerability concerns. We look forward to reporting initial data from the Phase 2a program later this year."

    Recent Corporate Developments

    • Updated Plan and Earlier Timing for First Interim Analysis of the URIROX-2 Phase 3 Trial 



      In July, the Company announced an updated plan and timing related to the first interim analysis of the URIROX-2 Phase 3 trial investigating reloxaliase, a first-in-class, orally administered, non-absorbed enzyme in development for enteric hyperoxaluria. Reloxaliase is being studied in the adaptive-design URIROX-2 trial, the second of two pivotal Phase 3 clinical trials in the reloxaliase program.



      As part of the URIROX-2 adaptive design, the Company had previously planned to conduct the first interim analysis after 130 subjects had been treated for at least six months and had estimated the timing of this analysis to be in the second or third quarter of 2022. Given the adverse impact of the COVID-19 global pandemic on the rate of patient enrollment in this global study, and considering that enrollment in the study began in early 2019, the Company announced that it had modified its plans and now expects to conduct the first interim analysis, which will include all patients who are enrolled in the trial by the end of November 2021 (currently expected to be approximately 80 patients), during the first quarter of 2022.



      The revised interim analysis, which will be conducted by an independent data monitoring committee, will assess whether the study continues to be adequately powered to evaluate efficacy against the primary endpoint, the change in urinary oxalate levels during weeks 1-4 versus baseline, with the planned enrollment of 200 subjects, or whether the study size should be increased. Any adjustment in study size would be designed to ensure that the statistical power of the study remains sufficiently robust. As previously planned, the interim analysis will also include an assessment of futility with respect to the primary endpoint.
    • Initiation of Phase 2a Program for ALLN-346



      In July, Allena announced that it had completed a Phase 1b multiple ascending dose study of ALLN-346, its first-in-class, non-absorbed, orally administered enzyme in development for the treatment of hyperuricemia and gout in the setting of advanced chronic kidney disease. The Company also recently initiated dosing for the ALLN-346 201 Trial, the first of two planned, randomized, double-blind, placebo-controlled Phase 2a trials designed to assess initial bioactivity data and additional safety data for ALLN-346. Initial results from the Phase 2a program are expected during the fourth quarter of 2021.
    • KOL Webinar Hosted by Allena Highlighted Unmet Need in Gout and Potential for ALLN-346



      In June, the Company highlighted the treatment paradigms and also limitations of existing gout therapies in a webinar hosted with key opinion leader (KOL), Robert Terkeltaub, M.D., Professor of Medicine at the University of California San Diego School of Medicine and Section Chief of Rheumatology at the Veterans Administration Medical Center in San Diego (a replay of the webinar can be found here). Managing gout in the setting of advanced chronic kidney disease remains a significant challenge for clinicians because currently available agents are either dose-limited or contraindicated in these patients. There are approximately 500,000 patients with gout and advanced chronic kidney disease in the United States.
    • $28.0 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules



      In July, Allena completed a registered direct offering priced at-the-market under Nasdaq rules. Net proceeds to the Company were $25.4 million after deducting placement agent fees and other offering expenses.

    Second Quarter 2021 Financial Results:

    • Research and development expenses increased by $6.3 million to $10.1 million for the second quarter of 2021 compared to the second quarter of 2020. The increase was primarily due to increased costs incurred for the reloxaliase program along with an increase in costs associated with the ALLN-346 program.
    • General and administrative expenses increased by $0.8 million to $3.6 million for the second quarter of 2021 compared to the second quarter of 2020. The increase was primarily due to an increase in consulting and professional services costs and insurance costs.
    • Net loss increased by $7.0 million to $14.0 million for the second quarter of 2021 compared to the second quarter of 2020, primarily as a result of the factors noted above. 
    • The cash and cash equivalents balance as of June 30, 2021 was $26.7 million, which includes $1.8 million of net proceeds raised during the second quarter from sales of common stock through an at-the-market equity issuance facility. In addition, the Company raised net proceeds of $25.4 million from the registered direct offering completed in July 2021.

    Year to Date 2021 (Six-Month) Financial Results:

    • Research and development expenses increased by $9.5 million to $18.0 million for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The increase was primarily due to increased costs incurred for the reloxaliase program along with an increase in costs associated with the ALLN-346 program.
    • General and administrative expenses increased by $1.5 million to $7.2 million for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The increase was primarily due to an increase in consulting and professional services costs and insurance costs.
    • Net loss increased by $11.0 million to $25.6 million for the six months ended June 30, 2021 compared to the six months ended June 30, 2020, primarily as a result of the factors noted above. 



     
    Allena Pharmaceuticals, Inc
    Condensed Consolidated Statements of Operations
    (in thousands, except share and per share data)
    (unaudited)
            
     For the Three Months Ended

    June 30,
     For the Six Months Ended

    June 30,
      2021   2020   2021   2020 
    Operating expenses:       
    Research and development$10,090  $3,808  $17,942  $8,454 
    General and administrative 3,597   2,751   7,155   5,629 
    Total operating expenses 13,687   6,559   25,097   14,083 
    Other income (expense), net (285)  (417)  (511)  (478)
    Net loss$(13,972) $(6,976) $(25,608) $(14,561)
    Net loss per share attributable to common

    stockholders—basic and diluted
    $(0.24) $(0.26) $(0.45) $(0.56)
    Weighted-average common shares

    outstanding—basic and diluted
     57,932,389   26,878,962   56,484,811   25,808,043 
                    





    Allena Pharmaceuticals, Inc
    Selected Condensed Consolidated Balance Sheet Data
    (in thousands)
    (unaudited)
         
      As of

    June 30, 2021
     As of

    December 31, 2020
    Cash and cash equivalents $26,656 $35,042
    Working capital   20,524  31,127
    Total assets  30,285  38,931
    Loan payable, net of current portion and discount  9,880  9,853
    Total stockholders' equity  12,267  22,569
         

    About Allena Pharmaceuticals

    Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company leveraging its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to-treat metabolic diseases. Allena's lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with a Phase 1 multiple-ascending dose study recently completed and a Phase 2a program recently initiated.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the future clinical, regulatory and commercial potential of reloxaliase, statements regarding enrollment and the timing of the planned interim analysis in the URIROX-2 trial, the impact of an earlier initial interim analysis on the size and duration of the URIROX-2 trial, statements regarding Allena's strategy of pursuing a BLA submission for reloxaliase based upon data from its URIROX program using the accelerated approval regulatory pathway, which strategy is predicated on the FDA's agreement with our predictive model supporting a relationship between UOx levels and kidney stone formation rates, statements regarding Allena's development of ALLN-346 including the timing of planned clinical trials and the announcement of topline data for these trials, and statements regarding Allena's financial position and need for capital. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: market and other conditions, the timing for completion of Allena's clinical trials of its product candidates, risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risks associated with Allena's financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena's dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Allena's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as well as discussions of potential risks, uncertainties and other important factors in Allena's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.

    Investor Relations Contact:

    Ashley R. Robinson

    LifeSci Advisors, LLC

    Tel: 617-430-7577

    arr@lifesciadvisors.com

    Media Contact

    Adam Daley

    Berry & Company Public Relations

    212-253-8881

    adaley@berrypr.com



    Primary Logo

    View Full Article Hide Full Article
  2. NEWTON, Mass., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced that company management will participate in the upcoming 12th Annual Wedbush PacGrow Healthcare Conference on August 10th – August 11th, 2021.

    Louis Brenner, M.D., Allena's President and Chief Executive Officer, will participate in the Casino Re-nal Part 2 - Cysts and Stones panel discussion. Details for the panel discussion are below:

    Casino Re-nal Part 2 - Cysts and Stones Panel
    Date:4:05 pm ET
    Time:Wednesday, August 11th, 2021
    Webcast:

    NEWTON, Mass., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced that company management will participate in the upcoming 12th Annual Wedbush PacGrow Healthcare Conference on August 10th – August 11th, 2021.

    Louis Brenner, M.D., Allena's President and Chief Executive Officer, will participate in the Casino Re-nal Part 2 - Cysts and Stones panel discussion. Details for the panel discussion are below:

    Casino Re-nal Part 2 - Cysts and Stones Panel
    Date:4:05 pm ET
    Time:Wednesday, August 11th, 2021
    Webcast:https://wsw.com/webcast/wedbush39/panel25/2580370

    Management will also be available for 1x1 meetings on Tuesday, August 10th – Wednesday, August 11th, 2021.

    About Allena Pharmaceuticals



    Allena Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class, oral biologic therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena's lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with a Phase 1 multiple-ascending dose study recently completed and a Phase 2a program planned for the second half of 2021.

    Investor Contact

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    arr@lifesciadvisors.com

    Media Contact

    Adam Daley

    Berry & Company Public Relations

    212-253-8881

    adaley@berrypr.com



    Primary Logo

    View Full Article Hide Full Article
  3. NEWTON, Mass., July 13, 2021 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced that it has entered into definitive agreements with several healthcare-focused institutional and accredited investors for the purchase and sale of 21,357,744 shares of the Company's common stock (or common stock equivalents) and warrants to purchase up to an aggregate of 10,678,872 shares of the Company's common stock, at a purchase price of $1.311 per share of common stock (or common stock equivalent) and associated warrant, in a registered…

    NEWTON, Mass., July 13, 2021 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced that it has entered into definitive agreements with several healthcare-focused institutional and accredited investors for the purchase and sale of 21,357,744 shares of the Company's common stock (or common stock equivalents) and warrants to purchase up to an aggregate of 10,678,872 shares of the Company's common stock, at a purchase price of $1.311 per share of common stock (or common stock equivalent) and associated warrant, in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about July 16, 2021, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The warrants have an exercise price of $1.25 per share, are exercisable immediately and have a term of five years.

    The gross proceeds to the Company from this offering are expected to be approximately $28 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. 

    The foregoing securities are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-228656) previously filed with the Securities and Exchange Commission (the "SEC") on December 3, 2018, and declared effective by the SEC on December 26, 2018. The offering of the securities is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC.  Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at placements@hcwco.com.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Allena Pharmaceuticals



    Allena Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class, oral biologic therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena's lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with a Phase 1 multiple-ascending dose study recently completed and a Phase 2a program planned for the second half of 2021.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering. In addition, it should be noted that additional capital will be required to complete the company's planned URIROX-2 clinical trial, which capital may not be available to Allena on terms that are acceptable to it, if at all. If adequate funds are not available on a timely basis, Allena may be required to delay, limit, reduce or terminate its clinical development of reloxaliase. The impact of the COVID-19 coronavirus on Allena's business, the biotech sector generally and the broader macroeconomic environment is uncertain and could harm Allena's business by delaying regulatory review timelines, clinical development plans and our ability to raise necessary capital. Furthermore, Allena does not have sufficient cash to operate its business for the next 12 months, which raises substantial doubt about its ability to continue as a going concern. Allena will require additional capital to fund its planned operations, which may not be available to it on attractive terms or at all. If the company is unable to secure additional capital, it will be forced to delay, limit, reduce or terminate its development of reloxaliase and may not be able to continue as a going concern. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the results of the URIROX-1 clinical trial may not be replicated in the URIROX-2 or other clinical trials of reloxaliase; the risk that the reduction in 24-hour UOx excretion observed in the placebo arm of the URIROX-1 trial may be observed in the URIROX-2 or other clinical trials of reloxaliase, which may have a negative impact on Allena's ability to secure regulatory approval for this product candidate; the risk that results of earlier studies, or interim results, may not be predictive of future clinical trial results, and planned and ongoing studies may not establish an adequate safety or efficacy profile for reloxaliase to support regulatory approval or the use of the accelerated approval regulatory pathway; risks related to Allena's ability to utilize the accelerated approval pathway for reloxaliase, including the risk that available data at the time of any sample size re-estimation or interim analysis conducted during the URIROX-2 trial may not be sufficient to demonstrate an increased probability of kidney stone events in patients with enteric hyperoxaluria and increasing UOx levels; the risk that the FDA may require that Allena increase the sample size or duration of treatment following the sample size reassessments to be conducted in accordance with the adaptive design element of the trial or otherwise collect additional clinical data from the URIROX-2 or other clinical trials prior to submitting a BLA for reloxaliase; risks associated with Allena's ability to enroll a sufficient number of patients to adequately power URIROX-2 in order to achieve ultimate statistical success for kidney stone disease progression in the long-term follow-up phase of the trial; risks related to Allena's use of UOx and/or POx as surrogate endpoints in its ongoing clinical trials, neither of which it believes have been previously utilized as biomarkers to support regulatory approval of other drug candidates, and the risks related to validating that reductions in UOx and/or POx correlate with meaningful clinical benefit; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risk associated with Allena's financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena's dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Item 1A of Part I of Allena's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as well as discussions of potential risks, uncertainties and other important factors in Allena's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.

    Investor Contact

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    arr@lifesciadvisors.com

    Media Contact

    Adam Daley

    Berry & Company Public Relations

    212-253-8881

    adaley@berrypr.com



    Primary Logo

    View Full Article Hide Full Article
  4. -ALLN-346 successfully completes Phase 1b safety study; on track to start two Phase 2a studies in Q3 2021 with initial data expected in Q4 2021-

    -Reloxaliase advancing in URIROX-2 Pivotal Phase 3 study; revised interim analysis now targeted for Q1 2022-

    NEWTON, Mass., July 12, 2021 (GLOBE NEWSWIRE) --  Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today provided progress updates on its clinical programs: ALLN-346, a first-in-class, oral urate degrading enzyme in development for the treatment of patients with hyperuricemia and gout…

    -ALLN-346 successfully completes Phase 1b safety study; on track to start two Phase 2a studies in Q3 2021 with initial data expected in Q4 2021-

    -Reloxaliase advancing in URIROX-2 Pivotal Phase 3 study; revised interim analysis now targeted for Q1 2022-

    NEWTON, Mass., July 12, 2021 (GLOBE NEWSWIRE) --  Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today provided progress updates on its clinical programs: ALLN-346, a first-in-class, oral urate degrading enzyme in development for the treatment of patients with hyperuricemia and gout in the setting of chronic kidney disease (CKD) and reloxaliase (ALLN-177), a first-in-class, oral oxalate degrading enzyme in development for the treatment of patients with enteric hyperoxaluria.

    ALLN-346: Phase 1b Study Results and Planned Phase 2A Program

    ALLN-346 is an investigational first-in-class, non-absorbed, orally administered enzyme for the treatment of hyperuricemia and gout, a metabolic disorder characterized by high systemic levels of uric acid that can lead to several complications, including arthritis, kidney stones, and chronic kidney disease.

    The Company recently completed a Phase 1b multiple ascending dose study of ALLN-346. The study included 18 healthy volunteers, who received either ALLN-346 or placebo (2:1 randomization) for seven days. There were two cohorts consisting of nine subjects each, with the first receiving three capsules of ALLN-346 three times daily, and the second receiving five capsules of ALLN-346 three times daily. ALLN-346 was well tolerated with no evidence of systemic absorption, as confirmed by an enzyme-linked immunosorbent assay (ELISA). Evaluation of clinical and laboratory parameters revealed no significant safety signals and no serious adverse events were reported.

    As previously reported, the Company is preparing to initiate two randomized, double-blind, placebo-controlled Phase 2a studies to obtain initial bioactivity data and additional safety data for ALLN-346 in patients with hyperuricemia and gout during the third quarter of 2021. Initial results from the Phase 2a program are expected during the fourth quarter of 2021.

    An inpatient study (Study 201) is planned to initially enroll 12 patients with hyperuricemia randomized (2:1) to receive either five capsules of ALLN-346 or matching placebo three times daily during a one-week treatment period. Key bioactivity endpoints will include serum uric acid level, 24-hour urine uric acid level, and renal clearance of uric acid. Following evaluation of the data from the initial 12 patients, the Company will make a determination regarding potentially extending the study to include up to an additional 12 patients, either to obtain additional data at the five-capsule, three-times-daily dose, or to evaluate a different dose.

    An outpatient study (Study 202) is planned to enroll 24 hyperuricemic patients with gout and mild-to-moderate chronic kidney disease randomized (2:1) to receive either five capsules of ALLN-346 or matching placebo, three times daily, during a two-week treatment period. Two cohorts of 12 patients each are planned, with the first cohort consisting of patients with an eGFR (estimated glomerular filtration rate, a measure of renal function) of 60-89 mls/minute, and the second consisting of patients with an eGFR of 30-59 mls/minute. Key bioactivity endpoints will include serum uric acid level, 24-hour urine uric acid level, and renal clearance of uric acid.

    The limitations of existing gout treatments were highlighted in the Company's recent KOL Webinar. Specifically, managing gout in the setting of advanced chronic kidney disease remains a significant challenge for clinicians because currently available agents are either dose-limited or contraindicated in these patients. There are approximately 500,000 patients with gout and advanced chronic kidney disease in the United States.

    Reloxaliase: Revised Plan for First Interim Analysis

    Reloxaliase is an investigational, first-in-class, non-absorbed, orally administered enzyme for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by high levels of urinary oxalate (UOx), which can lead to kidney stone disease and chronic kidney disease. There are currently no approved therapies for this disorder, which affects approximately 250,000 patients in the United States. Reloxaliase exerts its effect by breaking down oxalate in the gastrointestinal (GI) tract, reducing the absorption of dietary oxalate. The Company previously completed the URIROX-1 trial, the first of two pivotal Phase 3 clinical trials of reloxaliase, which demonstrated a statistically significant reduction in UOx levels during weeks 1-4, the primary endpoint of the study. The Company is currently studying reloxaliase in the adaptive-design URIROX-2 trial, the second of two pivotal Phase 3 clinical trials in its URIROX program.

    URIROX-2 is a multicenter, global, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of reloxaliase in patients with enteric hyperoxaluria over a minimum treatment period of two years. The trial is designed to enroll 200 patients with 24-hour UOx excretion greater than or equal to 50 mg/day and a history of kidney stones, and includes patients with both normal kidney function and reduced kidney function up to Stage 3 chronic kidney disease (eGFR > 30 mL/min). The primary efficacy endpoint of URIROX-2 is the percent change from baseline in 24-hour UOx excretion during weeks 1-4, the same primary endpoint as URIROX-1. Secondary endpoints in URIROX-2 include the percent change from baseline in 24-hour UOx excretion during weeks 16-24 and the proportion of subjects with a ≥ 20% reduction from baseline in 24-hour UOx excretion during Weeks 1-4. The primary long-term efficacy endpoint to confirm clinical benefit is kidney stone disease progression, defined as a composite of either symptomatic kidney stones or finding of new or enlarged kidney stones using imaging, over a minimum treatment period of two years. Secondary long-term efficacy endpoints to confirm clinical benefit include change in eGFR from baseline and resource utilization for the management of kidney stones. URIROX-2 incorporates adaptive design elements that could, if necessary, allow for increasing the sample size and/or duration of treatment based upon the results of two interim analyses.

    As part of the URIROX-2 adaptive design, the Company had previously planned to conduct the first interim analysis after 130 subjects had been treated for at least six months and had estimated the timing of this analysis to be in the second or third quarter of 2022. Given the adverse impact of the COVID-19 global pandemic on the rate of patient enrollment in this global study, and considering as well that enrollment in the study began in early 2019, the Company has modified its plans and now expects to conduct the first interim analysis, which will include all subjects who were enrolled in the trial as of the end of November 2021, during the first quarter of 2022. Based upon the number of subjects enrolled to date, the number of subjects currently in screening, and management's estimate of expected enrollment over the next several months through November, the Company estimates that this revised interim analysis would include UOx data during weeks 1-4 for approximately 80 patients but would not include sufficient data to evaluate UOx levels during weeks 16-24 or the blinded rate of kidney stone events, as previously planned. The Company will submit its revised plan for the first interim analysis to the Food and Drug Administration (FDA) as part of its planned update to the URIROX-2 statistical analysis plan and adaptive design charter.

    The revised interim analysis, which will be conducted by an independent data monitoring committee, will assess whether the study continues to be adequately powered to evaluate efficacy against the primary endpoint, the change in UOx levels during weeks 1-4 versus baseline, with the planned enrollment of 200 subjects, or whether the study size should be increased. As a result of conducting an earlier interim analysis with a smaller sample size than previously planned, the Company anticipates that the ultimate size of the study may be larger than would have otherwise been required, but that if this occurs, any such increase would be modest relative to an increase, if any, that would have been necessary had the first interim analysis been conducted with six-month data on 130 patients, as previously planned. Any adjustment in study size would be designed to ensure that the statistical power of the study remains sufficiently robust. As previously planned, the interim analysis will also include an assessment of futility with respect to the primary endpoint.

    The Company does not anticipate any changes to the planned second interim analysis, which will also include an assessment of the secondary endpoint of change in UOx levels during weeks 16-24 and of unblinded kidney stone events. The second interim analysis is expected to be conducted once 200 subjects have reached six months of treatment and is designed to enable a potential filing for accelerated approval for reloxaliase on the basis of UOx levels. The Company expects to provide revised guidance on its expectations for the timing of the second interim analysis and topline data from the URIROX-2 study following completion of the initial interim analysis in the first quarter of 2022.

    "We are encouraged by the progress of our two clinical programs, which we have sustained despite the challenges presented by the Covid-19 pandemic," stated Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals, Inc. "We are focused on continuing to advance our bacterial-derived oral enzyme product candidates through clinical development for patients with significant unmet needs in enteric hyperoxaluria and gout with CKD. We believe that the recent attention to the potential of synthetic biology and microbiome-derived therapeutics highlights the potential broad applicability of our technology."

    "In our ongoing URIROX-2 study in enteric hyperoxaluria, our trial simulation analyses give us confidence that an earlier URIROX-2 interim analysis will not result in a material impact on the size of the trial relative to any increase in size that might have been necessary had the first interim analysis been conducted with a larger data set as previously planned, and we believe it will provide meaningful and timely feedback for the conduct and ultimate completion of the adaptive design trial," added Dr. Brenner. "In addition, we look forward to seeing the first data from hyperuricemic subjects treated with ALLN-346 late this year."

    About Allena Pharmaceuticals

    Allena Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class, oral biologic therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena's lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with a Phase 1 multiple-ascending dose study recently completed and a Phase 2a program planned for the second half of 2021.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the future clinical, regulatory and commercial potential of reloxaliase, statements regarding enrollment and the timing of the planned interim analysis in the URIROX-2 trial, the impact of an earlier initial interim analysis on the size and duration of the URIROX-2 trial, statements regarding Allena's strategy of pursuing a BLA submission for reloxaliase based upon data from its URIROX program using the accelerated approval regulatory pathway, which strategy is predicated on the FDA's agreement with our predictive model supporting a relationship between UOx levels and stone formation rates, statements regarding Allena's development of ALLN-346 including the timing of planned clinical trials and the announcement of topline date for these trials, and statements regarding Allena's financial position and need for capital. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: market and other conditions, the timing for completion of Allena's clinical trials of its product candidates, risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risks associated with Allena's financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena's dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Allena's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as well as discussions of potential risks, uncertainties and other important factors in Allena's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.

    Investor Relations Contact:

    Ashley R. Robinson

    LifeSci Advisors, LLC

    Tel: 617-430-7577

    arr@lifesciadvisors.com

    Media Contact

    Adam Daley

    Berry & Company Public Relations

    212-253-8881

    adaley@berrypr.com



    Primary Logo

    View Full Article Hide Full Article
View All Allena Pharmaceuticals Inc. News