Veru Announces Novel Modified-Release Oral Formulation for Enobosarm

Veru Inc. VERU recently announced the selection of a novel modified-release oral formulation for enobosarm for chronic weight loss management. Enobosarm is a selective androgen receptor modulator (SARM) being developed as a next-generation drug that makes weight reduction by GLP-1 RA drugs more tissue-selective for loss of fat and preservation of lean mass.

The latest development follows confirmation of pharmacokinetic endpoints in a clinical study. The novel modified-release oral formulation of enobosarm was developed in collaboration with Laxxon Medical using smart delivery systems, including its proprietary patented SPID-Technology to create advanced, unique oral delivery release profiles, as well as an innovative additive manufacturing process.

More on Veru’s Newest Innovation

The single-dose, open-label pilot study examined the plasma concentration versus time profile of a proprietary, patentable modified-release formulation of enobosarm 3mg. The new formulation achieved the intended distinct target product release profile, which includes a reduction in maximum plasma concentration, a delayed time to maximum plasma concentration, a distinct secondary peak plasma concentration and a similar extent of absorption compared to historical values for enobosarm immediate release capsules.

Moreover, the novel enobosarm oral formulation’s unique manufacturing process is protected by a robust patent estate of issued global patents with protection through 2037 and beyond. Patent applications on enobosarm’s new oral formulation have been filed, and if issued, the expiry is expected to be 2046. According to Veru’s key leadership, the novel modified-release oral enobosarm formulation is planned to be available for Phase 3 clinical studies and commercialization.

Other Developments Within Veru

In June, Veru announced positive top-line efficacy and safety results from the maintenance extension portion of the Phase 2b QUALITY clinical study. The Phase 2b Maintenance Extension clinical trial demonstrated that in 12 weeks after stopping semaglutide, the placebo monotherapy group regained 43% of the body weight that was previously lost during the Phase 2b QUALITY study. Meanwhile, enobosarm monotherapy reduced weight regain by 46% in the enobosarm 3mg group and completely prevented fat regain and preserved lean mass in both enobosarm dose groups compared to placebo after semaglutide discontinuation. 

Industry Prospects Favor Veru

As per a Fortune Business Insights report, the global anti-obesity drug market size was valued at $4.51 billion in 2023 and is expected to grow at a compound annual growth rate of 25.5% through 2032. The prevalence rate of obesity has significantly increased over the past few decades, reaching epidemic levels. Several companies are developing and are engaged in launching effective therapeutics, strategically endorsing their products to tackle the problem, which is propelling the growth of the anti-obesity drug market.

Updates From Veru’s Peers

Like Veru, other drugmakers are also advancing better obesity treatments by enhancing the quality of weight loss.

Among them is Regeneron Pharmaceuticals, Inc. REGN, which recently announced a strategic in-licensing agreement with Hansoh Pharmaceuticals Group Company Limited to acquire exclusive clinical development and commercial rights outside of the Chinese Mainland, Hong Kong, and Macau for a dual GLP-1/GIP receptor agonist currently in Phase 3 testing. According to a top Regeneron official, securing access to a GLP-1/GIP receptor agonist will increase the versatility of the company’s clinical programs for obesity and boost its mission to support quality, sustained weight loss and associated long-term health benefits.

Eli Lilly and Company’s LLY experimental drug, bimagrumab, in combination with Wegovy, results in significant fat loss while preserving lean mass. Findings from the placebo-controlled Phase IIb BELIEVE study revealed that the combination therapy resulted in a 22.1% decrease in body weight, with 92.8% of the weight loss from fat mass. Eli Lilly also recently announced positive top-line results from the Phase 3 ATTAIN-1 trial, evaluating orforglipron — an investigational oral GLP-1 receptor agonist. The outcome showed significant efficacy, and a safety and tolerability profile consistent with injectable GLP-1 therapies at 72 weeks.

Another peer, Scholar Rock SRRK, recently reported positive results from the Phase 2 EMBRAZE proof-of-concept trial assessing apitegromab in combination with tirzepatide to preserve lean mass during tirzepatide-induced weight loss. Apitegromab is an investigational fully human monoclonal antibody inhibiting myostatin activation by selectively binding the pro- and latent forms of myostatin in the skeletal muscle. The EMBLAZE trial demonstrated that 30% of total weight loss with tirzepatide alone was due to lean mass loss. As per a Scholar Rock representative, the results support the hypothesis that the platform of highly selective myostatin inhibitors could support healthier weight loss for millions of patients on GLP therapies by safely preserving lean mass.

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