RedHill Biopharma Starts Phase 2 Prostate Cancer Study

TL;DR

RedHill Biopharma is kicking off a Phase 2 trial for advanced prostate cancer with opaganib and darolutamide.

AI Summary

RedHill Biopharma Ltd. announced on February 4, 2025, the initiation of a Phase 2 study for its drug candidate, opaganib, in combination with darolutamide, for the treatment of advanced prostate cancer. The study will enroll approximately 100 patients and aims to evaluate the safety and efficacy of this combination therapy.

Why It Matters

This study represents a significant step in RedHill's development pipeline, potentially offering a new treatment option for advanced prostate cancer patients if successful.

Risk Assessment

Risk Level: medium — Clinical trial initiations carry inherent risks related to patient recruitment, study outcomes, and regulatory approvals.

Key Numbers

• 100 — Patients (Approximate enrollment for the Phase 2 study)

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• Opaganib (drug) — Investigational drug candidate
• Darolutamide (drug) — Investigational drug
• Prostate Cancer (disease) — Target indication
• February 4, 2025 (date) — Announcement date

FAQ

Key Financial Figures

• $12 billion — ancer market is valued at approximately $12 billion 2 -- With multiple U.S. government c

Filing Documents

• zk2532647.htm (6-K) — 47KB
• image00001.jpg (GRAPHIC) — 657KB
• 0001178913-25-000313.txt ( ) — 953KB

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: February 4, 2025 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer Press Release RedHill Announces Initiation of Phase 2 Study of Opaganib and Darolutamide in Advanced Prostate Cancer The 80-patient placebo-controlled randomized Phase 2 study will evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis -- The study is being financially supported by Bayer (ETR: BAYN) and the Ramsay Hospital Research Foundation, and will be led by Professor Lisa Horvath from Chris O'Brien Lifehouse and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) -- The study will utilize a companion lipid biomarker test (PCPro 1 ) to select mCRPC patients who have a poor prognosis due to standard of care treatment and who may benefit from an opaganib + darolutamide combination treatment approach. Primary endpoint will be improved 12-month radiographic progression-free survival (rPFS) -- Prostate cancer (PC) is the second most diagnosed cancer in the world, with around 1.5 million new cases per year, causing almost 400,000 deaths. People with mCRPC have few treatment options available to them. The prostate cancer market is valued at approximately $12 billion 2 -- With multiple U.S. government collaborations for chemical and medical countermeasures and pandemic preparedness, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule, clinical-stage drug with demonstrated safety & efficacy profiles, being developed for various oncology, viral

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, among others, statements regarding the potential results of the Phase 2 study of opaganib and darolutamide in advanced prostate cancer. 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 maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs 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 its programs; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials;; the risk that the Company's development program

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