RedHill Biopharma Enrolls First Patient in COVID-19 Study

TL;DR

RHB-107 COVID-19 trial starts, first patient enrolled.

AI Summary

RedHill Biopharma Ltd. announced on April 24, 2024, that the first patient has been enrolled in its Phase 2 study for RHB-107 (upamostat) for the treatment of symptomatic COVID-19. The study, conducted in the United States, aims to evaluate the efficacy and safety of RHB-107 in non-hospitalized patients with mild-to-moderate COVID-19.

Why It Matters

This enrollment marks a significant step in the development of a potential new treatment for symptomatic COVID-19, which could impact patient care and public health.

Risk Assessment

Risk Level: medium — Clinical trial progress is subject to inherent risks, including efficacy, safety, and regulatory hurdles.

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• RHB-107 (drug) — Investigational drug for COVID-19
• upamostat (drug) — Investigational drug for COVID-19
• April 24, 2024 (date) — Announcement date
• United States (location) — Study location

FAQ

Filing Documents

• zk2431334.htm (6-K) — 36KB
• image00001.jpg (GRAPHIC) — 284KB
• 0001178913-24-001429.txt ( ) — 428KB

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: April 24, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer 2 Press Release RedHill Announces First Patient Enrolled in U.S. Government- Supported COVID-19 Study First patient enrolled in the global, 300-patient, Phase 2 adaptive platform trial arm of RHB-107 (upamostat) 1 for early COVID-19 outpatient treatment, funded through non-dilutive external sources, including the U.S. Department of Defense -- The study is expected to be completed by the end of 2024 – RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including marked reduction in hospitalization due to COVID-19 in a U.S. Phase 2 study 2 -- RHB-107 is a novel, oral, once-daily, host-directed potential broad-acting antiviral expected to act independently of viral spike protein mutations 3 RALEIGH, N.C. and TEL-AVIV, Israel, April 24, 2024, RedHill Biopharma Ltd. (Nasdaq: RDHL ) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the first patient has been enrolled in the Austere environments Consortium for Enhanced Sepsis Outcomes' (ACESO) U.S. government-supported PROTECT multinational platform trial for early COVID-19 outpatient treatment. RHB-107 (upamostat) is the first drug being tested in this platform study. Funded through non-dilutive external sources, including the U.S. Department of Defense, the PROTECT study is expected to be conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by the end of 2024. "Enrollment of the first patient in the study marks an important milestone for RHB-107 in the 300-patient U.S. government-supported PROTECT platform st

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. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. 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, the risk that the ACESO PROTECT study for RHB-107 may not be completed or, if completed, may not be successful or, even if successful, may not be sufficient support for regulatory applications, including emergency use or marketing applications, that additional COVID-19 studies for RHB-107 are likely to be required, and that we will not be successful in obtaining further non-dilutive development funding for RHB-107. Such risks and uncertainties also include those associated with the risk that the Company will not successfully commercialize its products, that the growth in prescriptions will not continue and the addition of new generating products will not occur, and that we will not be successful in increasing sales of our commercial products, including due to market and other conditions; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or t

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View this 6-K filing on SEC EDGAR