Veru Inc. (NASDAQ: VERU), a late clinical-stage biopharmaceutical company developing medicines for cardiometabolic and inflammatory diseases, has selected a proprietary modified release oral formulation of enobosarm for chronic weight loss management after confirming pharmacokinetic targets in a recent clinical study.
The single-dose, open-label pilot study evaluated the plasma concentration versus time profile of a patentable modified release 3mg enobosarm tablet. Results showed the new formulation achieved its intended release profile, including a reduction in maximum plasma concentration (Cmax), a delayed time to maximum concentration (Tmax), a distinct secondary peak, and a similar extent of absorption (AUC) compared to historical data for the immediate-release version.
“The novel enobosarm oral formulation’s unique manufacturing process is protected by a robust patent estate of already issued global patents with protection through 2037 and beyond. Patent applications on enobosarm’s new oral formulation have been filed and if issued, expiry is expected to be 2046,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “This novel modified release oral enobosarm formulation is planned to be available for the Phase 3 clinical studies and for commercialization.”
The new formulation was developed in partnership with Laxxon Medical, utilizing smart delivery systems and the company’s proprietary SPID®-Technology to create advanced oral release profiles via an additive manufacturing process.
“We are proud to partner with Veru, which leveraged our proprietary SPID®-Technology to develop a novel oral formulation while ensuring strong IP protection for future commercialization,” said Helmut Kerschbaumer, Chief Executive Officer of Laxxon Medical. “This innovation has the potential to meaningfully advance Veru’s clinical program and differentiate its enobosarm formulation.”
Enobosarm, a selective androgen receptor modulator (SARM), is designed to enhance fat loss while preserving lean muscle mass, complementing the effects of GLP-1 receptor agonists such as semaglutide. Veru has already reported positive topline and safety results from its Phase 2b QUALITY study in older patients receiving semaglutide for chronic weight management. That trial showed enobosarm significantly augmented fat loss and prevented muscle loss during treatment, and in a maintenance extension study, enobosarm monotherapy prevented weight and fat regain after semaglutide discontinuation.
According to Veru, these results confirm that preserving lean mass with enobosarm plus semaglutide leads to greater fat loss during active treatment, while enobosarm alone helps maintain weight reduction quality after GLP-1 therapy ends. The company has secured a meeting with the U.S. Food and Drug Administration to discuss its planned Phase 3 program.
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