Veru Inc., a clinical-stage biopharmaceutical company focused on developing new treatments for cardiometabolic and inflammatory diseases, announced it has selected a new modified release oral formulation of enobosarm. This selective androgen receptor modulator aims to help manage chronic weight loss, following positive pharmacokinetic results from a recent clinical trial. The pilot study was a single-dose, open-label trial that tracked drug levels in the blood over time for a proprietary 3mg modified release formulation. The results demonstrated that the new version achieved the desired release profile, including a lower peak concentration, a delayed time to peak, a secondary peak, and overall absorption comparable to previous immediate-release capsules.
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Mitchell Steiner, M.D., Chairman, President, and CEO of Veru, said, “The new oral version of enobosarm is supported by a strong patent portfolio with issued global patents that protect it until 2037 and beyond. We have also filed additional patent applications for this new formulation, which, if approved, would extend protection until 2046. This modified release version is intended for use in upcoming Phase 3 clinical trials and future commercialization plans.”
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Veru developed the formulation in partnership with Laxxon Medical using their proprietary SPID®-Technology, which allows for advanced and controlled oral drug release. The formulation also incorporates a modern additive manufacturing process that supports this unique delivery system. Helmut Kerschbaumer, CEO of Laxxon Medical, stated, “We are proud to work with Veru, applying our SPID®-Technology to develop this innovative oral formulation while ensuring strong intellectual property protection. This advancement has the potential to greatly improve Veru’s clinical development and distinguish their enobosarm in the market.”
This collaboration and the breakthrough formulation highlight Veru’s commitment to delivering innovative therapies with improved efficacy and safety profiles. These advancements are aimed at helping patients who face chronic weight loss and related health conditions.
Together, Veru and Laxxon Medical are paving the way for a new generation of treatments that combine cutting-edge science with robust intellectual property protections to maximize patient benefit and commercial success.
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