What’s Next in the Great GLP-1 Race?
Roche Holding (RHHBY) joined the race to commercialize its own GLP-1 (glucagon-like peptide-1) receptor agonist drug this week, announcing that its dual-agonist asset, CT-388, had achieved statistically significant weight loss in people with obesity in an early stage trial. At week 24 of treatment, 45% of participants achieved weight loss of approximately 20% of their body weight.
Competition in the weight loss field is fiercer than ever, as companies jostle to replicate the successes of Novo Nordisk (NOVO), the maker of Wegovy and Ozempic. To differentiate themselves from their competitors, many are focusing on developing more effective and longer-lasting formulations, preserving muscle during weight loss, and supporting weight management after GLP-1 drug dosing is discontinued.
This week, PRISM MarketView takes a closer look at the latest updates from companies emerging in the weight loss and obesity space, and their significant potential contributions to improving public health.
Fractyl Health, which launched a $100 million IPO in February 2024, shared six-month follow up data from its real-world registry study of Revita for type 2 diabetes (T2D) this week. Study participants experienced an average total body weight loss of 8.1% at six months after the Revita procedure, with generally sustained or improved weight loss from month 1 to month 6. Fractyl is positioning Revita as a potential treatment for durable maintenance of weight loss. Revita has received a CE mark in Europe and reimbursement authorization through in Germany for the treatment of type 2 diabetes. In the United States, Revita is available for investigational use only.
Viking Therapeutics, a metabolic and endocrine disorders company, recently reported positive topline results from its Phase 2 study of subcutaneous VK2735 in obesity, and encouraging initial data from a Phase 1 study of its novel tablet formulation. VK2735 met primary and secondary endpoints, demonstrated up to 13.1% placebo-adjusted weight loss at 13 weeks, and was shown to be safe and well-tolerated. The company expects to advance each program into further development later in 2024.
Biopharmaceutical company, Innovent Biologics (HKEX: 01801), is developing mazdutide, a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, as a treatment for obesity. The company announced in early May that its Phase 3 clinical trial had met its primary endpoint, demonstrating that mezdutide delivered glycemic control, and multiple cardiometabolic benefits in type 2 diabetes patients, including weight loss, lower blood lipids, lower blood pressure, and reduced liver enzymes. The drug also demonstrated favorable safety and tolerability. Innovent’s new drug application (NDA) for chronic weight management is currently under review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.
French biotech, Biophytis, announced the design of its Phase 2 clinical study evaluating BIO101 in obesity this week. The study will look at safety and efficacy in obese patients treated with GLP-1 RAs, together with hypocaloric dieting. The company said in a statement that it believes BIO101 has the potential to be the molecule of choice for preserving muscle function in patients suffering from obesity who are treated for weight loss with GLP-1 RAs. Biophytis expects to initiate a Phase 2 clinical trial in BIO101 in mid 2024, with preliminary results being reported in 2025.
Veru, a biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, this week announced the appointment of Steven B. Heymsfield, M.D., a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana, as the Principal Investigator for the company’s Phase 2b clinical trial of enobosarm to preserve muscle while augmenting fat loss in patients receiving a GLP-1 RA for weight loss. Veru expects to begin enrolling patients in the study imminently, and plans to report data by the end of 2024.
