RedHill Biopharma has announced significant development progress for RHB-102 (Bekinda), targeting gastrointestinal (GI) side effects associated with GLP-1 and GIP receptor agonist therapies, including nausea, vomiting, and diarrhea—issues estimated to limit growth in the multi-billion-dollar GLP-1 market.
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation.
RHB-102 is a patent-protected, bimodal immediate and extended-release 5HT3 antagonist designed to improve titration success and reduce the leading cause of early discontinuation of diabetes and weight-loss therapies, including Mounjaro/Zepbound and Ozempic/Wegovy.
RedHill also disclosed plans to seek US FDA approval for oncology support and potential use in post-operative nausea and vomiting (PONV). If approved, RHB-102 could become the first oral 24-hour extended-release ondansetron antiemetic for chemotherapy- and radiotherapy-induced nausea and vomiting (CINV/RINV). Intellectual property coverage for GLP-1-associated nausea and vomiting has also progressed.
An extensive body of clinical and non-clinical data supports RHB-102’s potential across multiple indications, including gastroenteritis, IBS-D, and GLP-1/GIP therapy-related GI side effects. Data highlights include:
Phase 3 GUARD gastroenteritis study and Phase 2 IBS-D study, both meeting primary endpoints, published in JAMA Network Open and The American Journal of Gastroenterology, respectively.
Positive comparative PK clinical data and planned Phase 2 Proof-of-Concept study for GLP-1/GIP-associated GI side effects.
Dr. Terry Plasse, RedHill Medical Director, said:
"RHB-102's once-daily oral profile may improve titration success, which we believe may result in reaching and maintaining optimal GLP-1 receptor agonist doses. We have designed a Phase 2 Proof-of-Concept study of RHB-102 for GLP-1/GIP receptor agonist therapy-associated GI side effects, planned to commence as early as possible this year.
"The overall aim is to help patients navigate the 'danger zone' early months of therapy, where GI-side effects, like nausea, vomiting and diarrhea, are most prevalent. Ultimately, the target is to see fewer patients coming off GLP-1/GIP receptor agonist therapies before they have the chance to deliver their full potential."
Dr. Plasse added: "RedHill believes that RHB-102 is largely de-risked and supported by prior positive U.S. Phase 3 results in gastroenteritis/gastritis, positive U.S. Phase 2 results for IBS-D, and decades of ondansetron clinical use with more than 22 million U.S. emergency room prescriptions annually.
"We believe that our patent protected RHB-102 provides a compelling partnership choice with published late-stage data, standard manufacturing, low cost of goods sold and multiple potential indications including GLP-1 receptor agonist–associated GI side effects, acute gastroenteritis & gastritis, IBS-D and oncology support (chemotherapy/radiotherapy-induced nausea and vomiting CINV/RINV)."
