REGN News & Events

Regeneron Pharmaceuticals (REGN) announced Hansoh Pharmaceutical Group Company (HNSPF) has shared topline data from its Phase 3 trial in Chinese patients evaluating olatorepatide for the treatment of adults with obesity or who are overweight. Olatorepatide is a novel dual GLP-1/GIP receptor agonist for which Regeneron has exclusive clinical development and commercial rights outside of the Chinese Mainland, Hong Kong and Macau as part of a strategic in-licensing agreement. The Phase 3 randomized, double-blind, placebo-controlled trial conducted by Hansoh enrolled 604 adults across 33 clinical sites in mainland China and evaluated once-weekly olatorepatide compared to placebo for 48 weeks. The study assessed four cohorts, including 5 mg, 10 mg or 15 mg olatorepatide and placebo. The trial met its co-primary endpoints, demonstrating that olatorepatide compared to placebo led to a statistically significant reduction in body weight from baseline, and also a statistically significant greater proportion of participants who achieved at least 5% weight loss at 48 weeks. Participants treated with olatorepatide achieved up to a 19% mean weight loss from baseline at week 48. Responder analyses showed that up to 97% of participants achieved greater than or equal to5% weight loss at week 48. Olatorepatide demonstrated a favorable gastrointestinal tolerability in the trial, with lower rates of gastrointestinal adverse events and treatment discontinuation relative to those reported in other published Phase 3 dual incretin trials. The average incidence of nausea was below 10%, and the average incidence of vomiting below 5%. Detailed data from the trial are planned to be presented at an upcoming medical meeting. The safety and efficacy of olatorepatide have not been evaluated by any regulatory authority. Hansoh holds the development and commercialization rights for olatorepatide in Greater China, while Regeneron holds the rights for development and commercialization outside Greater China.

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicines Agency's, EMA, Committee for Medicinal Products for Human Use, CHMP, adopted a positive opinion recommending the approval of Dupixent in the European Union for the treatment of chronic spontaneous urticaria. This recommendation covers children aged 2 to 11 years with moderate-to-severe CSU, an inadequate response to histamine-1 antihistamines and who are naive to anti-immunoglobulin E therapy for CSU. A final decision is expected in the coming months.