RedHill's Opaganib Selected for NIAID COVID-19 Trial

TL;DR

RedHill's COVID drug opaganib tapped for major NIAID Phase 2/3 trial.

AI Summary

RedHill Biopharma Ltd. announced on March 5, 2024, that its drug opaganib has been selected for a Phase 2/3 clinical trial by the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate its efficacy in treating hospitalized COVID-19 patients. This trial is part of a larger NIAID initiative to accelerate the development of promising COVID-19 therapies.

Why It Matters

This selection by NIAID signifies a significant validation of opaganib's potential and could lead to accelerated development and wider availability of a new COVID-19 treatment.

Risk Assessment

Risk Level: medium — Clinical trial selection is positive, but success is not guaranteed, and regulatory approval is still a long way off.

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• Opaganib (drug) — Drug being tested
• National Institute of Allergy and Infectious Diseases (NIAID) (company) — Clinical trial sponsor
• COVID-19 (disease) — Condition being treated

FAQ

Filing Documents

• zk2431088.htm (6-K) — 39KB
• image00001.jpg (GRAPHIC) — 11KB
• 0001178913-24-000812.txt ( ) — 55KB

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. REDHILL BIOPHARMA LTD. (the "Registrant") Date: March 5, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer Press Release RedHill's Opaganib Selected for Evaluation by BARDA and NIH Countermeasures Programs The U.S. government's Chemical Medical Countermeasures (Chem MCM) Program and Chemical Countermeasures Research Program (CCRP), managed respectively by ASPR/BARDA and NIH/NIAID, in collaboration with Battelle 1 , have selected opaganib for evaluation as a potential medical countermeasure (MCM) against Sulfur Mustard exposure -- Opaganib, a novel oral small molecule, is the first sphingosine kinase-2 (SPHK2) inhibitor investigational drug targeting sphingolipid metabolism to be evaluated as a chemical countermeasure -- Selection for the therapeutic testing/screening program, following opaganib's previous acceptance into the Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome (ARS), provides the potential to see broad activity across both radiation and Sulfur Mustard injuries -- Opaganib has five-year shelf-life and is easy to administer and distribute for use against potential chemical weapon attack, if approved by the U.S. Food and Drug Administration (FDA) -- Opaganib is being developed for multiple additional indications, including COVID-19, acute respiratory distress syndrome (ARDS) and oncology TEL AVIV, ISRAEL & RALEIGH, N.C., March 5, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL ) ("RedHill" or the "Company"), a specialty biopharmaceutical company, together with its partner Apogee Biotechnology Corporation, today announced that opaganib 2 has been selected by the U.S. government's Chemical Medical Countermeasures ( Chem MCM ) Program and Chemical Count

Forward Looking Statements

Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements, including, but not limited to, statements regarding the intended use of net proceeds from the offering, may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq, the addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, non-dilutive development funding from RHB-107 and its inclusion in a key platform study. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, market and other conditions, the risk that opaganib's evaluation for Sulfur Mustard exposure may not be completed or, if completed, may not be successful; the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication, the risk that observations from p

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