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Investing.com -- Redhill Biopharma Ltd (NASDAQ:RDHL) stock surged 28% after the company received positive feedback from the U.S. Food and Drug Administration (FDA) regarding the pathway to approval for its RHB-204 Crohn’s disease development program.
The FDA provided guidance that allows Redhill to conduct the first-ever clinical trial in Crohn’s disease targeting a specifically defined population of patients infected with Mycobacterium avium subspecies paratuberculosis (MAP-positive). This groundbreaking approach aims to treat both the suspected root cause of the disease and its symptoms, potentially positioning RHB-204 as a paradigm-shifting therapy if approved.
The planned Phase 2 study will focus on primary endpoints of mucosal remission and clinical remission, correlated with MAP status, as suggested by the FDA. These endpoints are supported by positive results from the company’s previous RHB-104 Phase 3 study. The novel study design, which will use imaging and advanced MAP detection methods, may enable a smaller sample size, potentially reducing costs and accelerating completion time.
RHB-204 is a next-generation formulation of the Phase 3-stage RHB-104, designed with 40% fewer pills to improve tolerability, safety, and patient adherence. The drug is patent-protected until 2041.
The development builds on data from a 331-patient Phase 3 study of RHB-104, which showed the drug plus standard of care was 64% more effective than standard care alone. Results also demonstrated safety and efficacy when used with other treatments such as anti-TNFs, immunomodulators, and steroids.
The Crohn’s disease market is projected to grow from $13.6 billion to $19.1 billion by 2033 across major markets, representing a 3.87% compound annual growth rate. Redhill is pursuing non-dilutive funding for the program through partnerships, collaborations, and grant applications.
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