RedHill Biopharma Ltd. (NASDAQ:RDHL) shares climbed 16.5% in premarket trading on Monday after the company reported advances in the development of RHB-102 (Bekinda), a therapy aimed at addressing gastrointestinal side effects linked to widely used GLP-1/GIP weight-loss and diabetes drugs.
The specialty biopharmaceutical group is progressing RHB-102—a once-daily oral formulation of ondansetron—through the U.S. Food and Drug Administration’s accelerated 505(b)(2) regulatory pathway. The treatment is intended to reduce nausea, vomiting and diarrhea, side effects that frequently cause patients to stop therapies such as Mounjaro/Zepbound and Ozempic/Wegovy prematurely.
RedHill said its development approach is underpinned by previously published positive Phase 3 data in gastroenteritis/gastritis and Phase 2 results in IBS-D. Building on this foundation, the company has designed a Phase 2 proof-of-concept study specifically targeting gastrointestinal side effects associated with GLP-1/GIP receptor agonist treatments, which is expected to begin later this year.
“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,” said Dr. Terry Plasse, RedHill’s Medical Director.
In parallel, RedHill is exploring the potential for FDA approval of RHB-102 in oncology supportive care. If successful, the drug could become the first oral, 24-hour extended-release ondansetron therapy for preventing nausea and vomiting caused by chemotherapy and radiotherapy.
The company noted that although more than 2% of the U.S. population is currently using GLP-1 receptor agonists, estimates indicate that up to half of patients discontinue treatment within three months due to side effects. According to Goldman Sachs, this level of discontinuation could trim projected GLP-1 market value by around $35 billion by 2030.