RedHill Expands RHB-102 Clinical Development Addressing GLP-1 Therapy-Related GI Side Effects And Broader GI Indications

RHB-1021 is a proprietary, advanced clinical-stage, once-daily, bimodal extended-release, oral tablet formulation of 5-HT3 antagonist, ondansetron, targeting oncology support, acute gastroenteritis and gastritis, IBS-D and GLP-1/GIP-associated gastrointestinal (GI) side effects

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Largey de-risked, RHB-102 development is supported by published positive U.S. Phase 3 & 2 results in gastroenteritis/gastritis and diarrhea-predominant irritable bowel syndrome (IBS-D) respectively, a positive comparative PK clinical study as part of the oncology support (CINV/RINV) program2, plus decades of ondansetron clinical use (>22 million annual U.S. ER prescriptions3)

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RHB-102 is clinically aligned, if approved, to improve titration success and reduce the #1 cause of discontinuing diabetes & weight loss therapies like Mounjaro®/Zepbound® & Ozempic®/Wegovy®

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Development planned under the accelerated FDA 505(b)(2) route of RHB-102 (Bekinda®) as a once-daily oral therapy for GLP-1/GIP receptor agonist therapy-associated GI side effects. Phase 2 Proof-of-Concept study designed, and intellectual property expanded

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>2% of Americans take GLP-1 receptor agonist drugs4 but estimates suggest up to 50% discontinue within 3 months5, potentially costing an estimated $35 billion in lost market value by 20306