Pharmaceutical Technology

FDA clears Veru’s IND for GLP-1 RA-associated muscle loss drug

Veru’s Ostarine has previously been investigated in five clinical studies in patients with muscle wastage caused by advanced cancer.

The US Food and Drug Administration (FDA) has cleared Veru’s investigational new drug (IND) application to advance its selective androgen receptor modulator (SARM) candidate Ostarine (enobosarm) to a Phase IIb clinical trial.

The double-blind, randomised, placebo-controlled Phase IIb trial will investigate Ostarine 3mg, 6mg as a treatment to prevent muscle loss in 90-patients taking GLP-1 RA’s who are at risk for muscle atrophy or muscle weakness. The study is measuring lean body mass as a primary endpoint and total body fat mass at 16 weeks as a secondary endpoint. The study expects to release topline data in Q4 2024.

Following completion of the Phase IIb efficacy dose-finding portion, the US-based biopharma company will continue patients in an open label extension trial where patients will receive 6 mg of Ostarine for 12 weeks to determine the ability of the drug to reverse muscle loss and prevent fat and weight rebound after stopping a GLP-1 RA. Results for the open label extension study are anticipated in Q2 2025.

With an IND clearance, the company aims to evaluate Ostarine as a combination treatment with GLP-1 inhibitors in a subpopulation of sarcopenic obese or overweight elderly patients who are particularly susceptible for developing muscle atrophy or muscle weakness, CEO Mitchell Steiner said in the 6 February press release.

According to GlobalData’s Pharma Intelligence Center, Ostarine is forecast to generate $201m in sales in 2029.

GlobalData is the parent company of Pharmaceutical Technology.

Veru, which has two FDA-approved sexual health products, received a class-action complaint against it in December 2022 after it failed to disclose negative information to its shareholders from a Phase III trial of Covid-19 drug sabizabulin, and its interactions with the FDA.

The drug was initially developed for prostate cancer but shifted its focus to treat severe Covid-19 cases in what was described as an ‘opportunistic’ move. Veru falsely suggested to shareholders that data from the Phase III trial was sufficient to support emergency use authorisation (EUA) and even the submission of a new drug application (NDA) without any further studies.