#RedHill Biopharma #GLP-1 #RHB-102

RedHill's RHB-102: A Game Changer for GI Side Effects

RedHill Biopharma, a biopharmaceutical company focusing on gastrointestinal and oncology products, has updated the public on the promising developments of RHB-102, its advanced clinical-stage drug. This once-daily oral medication, which utilizes a bimodal extended-release formulation of ondansetron, targets a multitude of gastrointestinal (GI) complications, particularly those associated with GLP-1 receptor agonist therapies like Mounjaro® and Ozempic®.

Clinical Significance of RHB-102

Gastrointestinal side effects—such as nausea, vomiting, and diarrhea—are common among many patients enduring GLP-1 therapies. Research indicates that as many as 50% of patients discontinue their medications within three months largely due to these adverse effects, which can lead to an estimated economic loss of $35 billion in market value by 2030. RHB-102 was developed to address this issue. Through its potential approval under the FDA's accelerated 505(b)(2) pathway, RHB-102 could offer a viable solution that enhances treatment adherence and minimizes early dropout rates.

Supporting Clinical Research

Recent clinical trials bolster RHB-102’s potential. The company revealed positive results from its U.S. Phase 3 GUARD study focused on gastroenteritis, alongside a successful Phase 2 study involving diarrhea-predominant irritable bowel syndrome (IBS-D). Both studies met their primary endpoints, as documented in major medical journals. With more than 22 million prescriptions for ondansetron in U.S. emergency rooms annually, the drug’s established history on the market enhances confidence in its potential efficacy.

Dr. Terry Plasse, RedHill’s Medical Director, emphasized the clinical promise, stating that RHB-102's unique formulation is specifically designed to improve titration success. By optimizing dosage management, the drug could help patients navigate the