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VERU - Veru Selects Novel Modified Release Oral Enobosarm Formulation for Chronic Weight Loss Management Following Pharmacokinetic Study
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(R)-Technology to create advanced oral release profiles via an additive manufacturing process.
"We are proud to partner with Veru, which leveraged our proprietary SPID(R)-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."
VERU - Veru Selects Novel Modified Release Oral Enobosarm... |
