Phase 3 Data Shows 64% Increased Efficacy of RedHill's RHB-104 in Crohn's Disease

A recent study published in the peer-reviewed journal Antibiotics presents promising data on a new treatment for Crohn's disease. Conducted by RedHill Biopharma Ltd., the Phase 3 clinical trial involved 331 patients and spanned over 100 sites globally. The study focused on the efficacy of RHB-104, a triple antimicrobial therapy targeting Mycobacterium avium subspecies paratuberculosis (MAP), in conjunction with the standard of care (SoC) treatments.

The primary endpoint of the study was clinical remission at week 26. Out of the 166 patients who were administered RHB-104 along with SoC, 36.7% achieved clinical remission, compared to 22.4% of patients who received a placebo plus SoC. This result was statistically significant with a p-value of 0.0048. Moreover, the safety profile of RHB-104 was found to be similar to that of the placebo, indicating that the treatment is generally well-tolerated.

Dr. David Y. Graham, Professor of Medicine and Molecular Virology and Microbiology at Baylor College of Medicine, led the study. He emphasized the significance of the data, stating that it supports the hypothesis that MAP infection might be a primary cause of Crohn's disease. The study was unique in that it allowed patients to continue their treatment with tumor necrosis factor (TNF) agents like infliximab and adalimumab, along with corticosteroids. Dr. Graham noted that RHB-104 was beneficial even for patients who were on these treatments, suggesting it could serve as an effective add-on therapy.

Crohn's disease is a form of inflammatory bowel disease (IBD) that causes inflammation of the digestive tract, leading to symptoms such as abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The condition affects an estimated one million Americans and poses a significant burden on healthcare systems due to its chronic nature and the lack of a known cure. The inflammation caused by Crohn's disease often affects the small intestine but can also spread further into the digestive tract.

The market for Crohn's disease treatments was valued at over $13 billion in 2023. Common therapies include Abbvie's Humira® (adalimumab), Janssen's Remicade® (infliximab) and Stelara® (ustekinumab), BMS's Zeposia® (ozanimod), and Pfizer's Xeljanz® (tofacitinib). The introduction of RHB-104 could potentially revolutionize the treatment landscape for Crohn's disease, offering a new therapeutic approach by targeting its possible bacterial cause.

Dror Ben-Asher, CEO of RedHill Biopharma, highlighted the potential paradigm shift that RHB-104 represents. He mentioned that the connection between MAP and Crohn's was first suggested over a century ago by Scottish surgeon Dalziel. The new data reinforces the growing body of evidence supporting the role of MAP in the etiology of Crohn's disease. Ben-Asher also discussed the company's plans to advance the development of RHB-104, including the pursuit of creative partnership models to expedite its progress.

RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on gastrointestinal and infectious diseases. The company also promotes other gastrointestinal drugs, such as Talicia® for Helicobacter pylori infection and Aemcolo® for travelers' diarrhea. RedHill's clinical pipeline includes several late-stage development programs targeting various medical conditions, indicating a robust research and development strategy.

The successful Phase 3 study of RHB-104 underscores the potential of antimicrobial therapy in treating Crohn's disease, possibly paving the way for new treatment paradigms in the field of inflammatory bowel diseases. Further research and collaboration will be crucial in bringing this promising therapy to market and improving the lives of millions affected by Crohn's disease.

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