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Regeneron Pharmaceuticals Inc (NASDAQ:REGN) released multiple ascending dose (MAD) data from a Phase 1 study evaluating garetosmab (anti-activin A) and trevogrumab (anti-myostatin) on body composition in healthy volunteers (n=34) at the American Diabetes Association meeting.
The data demonstrated that combination therapy led to greater-than-additive increases in lean mass while decreasing fat mass in healthy participants.
Thigh muscle volume (TMV) increased from baseline 7.7% with trevogrumab 6 mg/kg + garetosmab 10 mg/kg (vs. placebo) and 4.6% with trevogrumab 6 mg/kg (vs. placebo) 8 weeks after single-dose.
Total fat mass and android fat mass (AFM) decreased from baseline with trevogrumab 6 mg/kg + garetosmab 10 mg/kg (-4.6% and -6.7% vs. placebo).
After multiple-dose, TMV initially increased after 3 doses of trevogrumab 6 mg/kg + garetosmab 10 mg/kg but decreased to similar levels as a placebo at Week 28; AFM and visceral fat mass decreased from baseline by 14.3% and 20.1%, respectively (both vs. placebo).
Goldman Sachs says the data at ADA adds to the body of support for Regeneron's approach and highlights:
The analyst also adds that per management garetosmab monotherapy will not be evaluated in Phase 2.
The analyst maintains a Buy rating with a price target of $1,180.
Regeneron is conducting an ongoing Phase 2 study evaluating if the addition of trevogrumab to Novo Nordisk A/S’s (NYSE:NVO) semaglutide (popularly known as Wegvoy and Ozempic) with and without garetosmab improves the quality of weight loss and/or improves maintenance of weight loss post semaglutide discontinuation.
The study is expected to be completed in June 2026.
Goldman Sachs writes, “Overall, we see merit to Regeneron’s approach to improve the quality of weight loss (noting up to 40% of weight loss from incretin-based therapies is due to decreases in lean mass) and view it as an opportunity for Regeneron to capture share in body composition-focused assets, which could be additive to the $130 billion obesity total addressable market.”
Read Next: FDA Extends Review Deadline For Regeneron/Sanofi’s Dupixent For ‘Smoker’s Lungs’ Disease.
Price Action: REGN shares are up 1.29% at $1,066.8 at last check Monday.
Photo by Vidmir Rais via Pixabay
