RedHill Biopharma Obesity Study Shows Positive Results

TL;DR

RHB-107 shows promise in obesity/MASH trial, weight loss achieved vs placebo.

AI Summary

RedHill Biopharma Ltd. announced on August 19, 2024, positive top-line results from its Phase 2a study of RHB-107 (upamostat) for obesity and metabolic dysfunction-associated steatohepatitis (MASH). The study met its primary endpoint, demonstrating a statistically significant reduction in body weight compared to placebo. Further analysis is ongoing to evaluate secondary endpoints and potential therapeutic benefits.

Why It Matters

Positive results in obesity and MASH trials could lead to new treatment options for these widespread conditions, potentially impacting millions of patients and the healthcare market.

Risk Assessment

Risk Level: medium — While the results are positive, the study is Phase 2a, and further trials are needed to confirm efficacy and safety before commercialization.

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• RHB-107 (drug) — Investigational drug for obesity and MASH
• upamostat (drug) — Active ingredient in RHB-107
• August 19, 2024 (date) — Date of announcement

FAQ

Key Financial Figures

• $100 billion — market is projected to be worth around $100 billion by 2034 1 – largely driven by Glucagon

Filing Documents

• zk2431890.htm (6-K) — 37KB
• image00002.jpg (GRAPHIC) — 4KB
• 0001178913-24-002681.txt ( ) — 43KB

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: August 19, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer Press Release RedHill Announces Positive Obesity and Diabetes Results with Opaganib The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034 1 – largely driven by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk's Ozempic and Wegovy and Eli Lilly's Trulicity and Mounjaro and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim's Jardiance -- Positive results from multiple in vivo studies show the impact of sphingosine kinase-2 (SPHK2) inhibition in various models of metabolic disease, supporting the potential of opaganib therapy for diabetes and obesity-related disorders -- With multiple U.S. government collaborations ongoing, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection TEL-AVIV, Israel / RALEIGH, NC, August 19, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced positive results from multiple in vivo studies, undertaken by RedHill's partner, Apogee Biotechnology Corporation, showing the impact of opaganib 2 on weight gain and glucose tolerance in a high fat diet (HFD) model, supporting the potential clinical use of opaganib for the prevention and therapy of Type 2 diabetes and other obesity-related disorders. "Sphingolipid me

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 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 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 Company's ability to regain compliance with the Nasdaq Capital Market's minimum bid price requirements; the risk that 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 preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, t

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