MIAMI - Veru Inc. (NASDAQ: NASDAQ:VERU), a biopharmaceutical company, has announced the appointment of Dr. Steven B. Heymsfield as the Principal Investigator for its Phase 2b clinical trial of enobosarm. The trial aims to assess enobosarm's ability to preserve muscle while enhancing fat loss in patients using GLP-1 RA weight loss treatments.
Dr. Heymsfield, a recognized authority on body composition and obesity, will oversee the multicenter trial, which is currently enrolling participants. The study will evaluate enobosarm doses of 3mg and 6mg against a placebo in approximately 90 patients with sarcopenic obesity or those over 60 years old receiving semaglutide (Wegovy®). The primary outcome will be changes in lean body mass, with secondary measures including body fat mass and physical function, assessed over 16 weeks.
Enobosarm, a selective androgen receptor modulator (SARM), has been studied in 27 clinical trials involving 1,581 participants. It has shown promise in increasing muscle mass and improving physical function, while also reducing fat mass. The drug has been generally well tolerated in these studies, with no increase in gastrointestinal side effects, which is noteworthy given the frequent gastrointestinal side effects associated with GLP-1 RA treatments alone.
This Phase 2b trial is part of Veru's broader effort to address the unmet medical needs of patients undergoing weight loss treatment who are at risk of muscle atrophy and weakness. Topline results from the trial are expected by the end of 2024, with a subsequent extension study to explore enobosarm's potential in maintaining muscle and preventing weight regain post-GLP-1 RA therapy.
The prevalence of sarcopenic obesity in the U.S. is significant, particularly among the elderly, with up to 34.4% of obese individuals over 60 potentially benefiting from weight loss medications. The risk of muscle loss associated with GLP-1 RA therapies could lead to frailty and other health complications, underscoring the importance of this research.
Veru's product pipeline also includes sabizabulin for viral-induced ARDS and a FDA-approved FC2 Female Condom for dual protection against unplanned pregnancy and sexually transmitted infections. The company's focus remains on developing treatments for metabolic diseases, oncology, and ARDS.
This article is based on a press release statement from Veru Inc.
InvestingPro Insights
As Veru Inc. (NASDAQ: VERU) continues to advance its clinical trials and expand its product pipeline, investors and analysts are closely monitoring the company's financial health and market performance. According to InvestingPro data, Veru holds a market capitalization of 215.18 million USD, which provides a snapshot of the company's size in the competitive biopharmaceutical landscape. Despite the potential of enobosarm, Veru's revenue over the last twelve months as of Q2 2024 has declined by 36.67%, indicating challenges in its financial growth trajectory.
InvestingPro Tips suggest that while Veru holds more cash than debt, which is a positive sign of liquidity, the company is quickly burning through its cash reserves. Additionally, analysts do not anticipate the company will be profitable this year, which may be a concern for potential investors. The stock generally trades with high price volatility, which could be attributed to the speculative nature of biopharmaceutical investments and the market's reaction to the progress of clinical trials. Nevertheless, Veru has shown a strong return over the last three months, with a 250.0% price total return, reflecting investor optimism in the short term.
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