RedHill Biopharma Advances RHB-102 for Multiple Gastrointestinal Indications
RedHill Biopharma Ltd. (Nasdaq: RDHL), a specialty biopharmaceutical company, has made significant strides in the development of RHB-102 (Bekinda®). This proprietary, advanced clinical-stage oral medication is designed to address various gastrointestinal (GI) complications, particularly those linked to GLP-1 therapy, including nausea, vomiting, and diarrhea.
Overview of RHB-102 Development
RHB-102 is a bimodal extended-release formulation of ondansetron, a selective 5-HT3 antagonist. It aims to support patients dealing with oncology-related side effects as well as conditions like acute gastroenteritis, gastritis, and diarrhea-predominant irritable bowel syndrome (IBS-D). Clinical data back the RHB-102 development, with positive outcomes from U.S. Phase 3 and Phase 2 studies addressing gastroenteritis and IBS-D, respectively.
- RHB-102 is designed as a once-daily oral therapy.
- It seeks to improve titration success, reducing treatment discontinuation in diabetes and weight loss therapies such as Mounjaro® and Ozempic®.
- The development will follow the accelerated FDA 505(b)(2) approval pathway for optimal market entry.
Market Context and Implications
Over 2% of Americans currently use GLP-1 receptor agonist medications. However, studies show that up to 50% of these patients may discontinue their treatment within three months due to gastrointestinal side effects. This discontinuation poses a threat to the GLP-1 market, potentially resulting in $35 billion in lost value by 2030.
RedHill's RHB-102 could provide a critical solution to this challenge by mitigating side effects that deter patients from continuing their treatment regimens. Dr. Terry Plasse, RedHill’s Medical Director, highlighted that RHB-102's once-daily oral profile may significantly enhance titration success, allowing patients to maintain optimal GLP-1 doses.
Clinical Data and Future Studies
RHB-102's clinical candidacy is bolstered by extensive data, which includes:
- Successful completion of primary endpoints in the Phase 3 GUARD gastroenteritis study.
- Positive results from the Phase 2 IBS-D study, both published in credible medical journals.
- Supportive data from a comparative pharmacokinetic study related to chemotherapy-induced nausea and vomiting (CINV) and radiotherapy-induced nausea and vomiting (RINV).
A planned Phase 2 Proof-of-Concept study for RHB-102 addressing GI side effects linked to GLP-1/GIP receptor agonist therapy is set to begin as soon as possible this year.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is primarily focused on U.S. development and commercialization of medications for gastrointestinal diseases, infectious diseases, and oncology. In addition to RHB-102, RedHill promotes Talicia®, an FDA-approved drug for Helicobacter pylori infection, and is advancing other innovative therapies.
Conclusion
The development of RHB-102 represents a promising opportunity for RedHill Biopharma to address critical unmet needs in gastrointestinal health related to GLP-1 therapy. With its robust clinical backing and focus on improving patient outcomes, RHB-102 may redefine treatment paradigms in this growing market.