MIAMI, FL - Veru Inc. (NASDAQ: NASDAQ:VERU), a biopharmaceutical company, has received U.S. Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) application, the firm announced today. The approval allows Veru to proceed with a Phase 2b clinical trial evaluating enobosarm in combination with GLP-1 receptor agonist (GLP-1 RA) drugs for weight loss, with a focus on preserving muscle mass in elderly patients.
The randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of enobosarm in sarcopenic obese or overweight elderly patients already receiving GLP-1 RA therapy. The trial, which is expected to begin by April 2024, will involve 90 participants and measure primary outcomes in lean body mass and secondary outcomes in total body fat mass over 16 weeks. Topline results from the trial are anticipated by the end of 2024.
Following the dose-finding portion of the Phase 2b clinical trial, an open-label extension trial will commence, where all participants will receive enobosarm monotherapy to evaluate its potential in reversing muscle loss. Results from this extension are expected in the second quarter of 2025.
Enobosarm, also known as ostarine, has previously been studied in clinical trials involving older adults and patients with advanced cancer, showing dose-dependent increases in muscle mass and reductions in fat mass. Veru's Chairman, President, and CEO, Mitchell Steiner, M.D., expressed optimism about the drug's potential to enhance weight loss quality by preserving muscle while preferentially reducing fat.
Sarcopenic obesity, a condition characterized by muscle loss and obesity, affects up to 34.4% of U.S. adults over 60, according to the CDC. These individuals are particularly vulnerable to muscle atrophy and weakness when taking GLP-1 RA drugs, potentially leading to frailty.
Veru's pipeline also includes enobosarm for oncology and sabizabulin for ARDS treatment, though further development of sabizabulin is contingent on external funding.
The information in this article is based on a press release.
InvestingPro Insights
As Veru Inc. (NASDAQ: VERU) embarks on its promising Phase 2b clinical trial for enobosarm, investors are closely monitoring the company's financial health and stock performance. Recent data from InvestingPro indicates that Veru is grappling with challenges on the financial front. The company's market capitalization stands at a modest $71.73 million, reflecting investor sentiment and the size of the company in the competitive biopharmaceutical landscape.
One notable InvestingPro Tip for Veru is the company's rapid cash burn rate, which could impact its ability to fund ongoing and future research without securing additional financing. This is particularly relevant as the company explores the potential of enobosarm and seeks to expand its clinical trials. Additionally, with a P/E Ratio (Adjusted) for the last twelve months as of Q4 2023 at -0.76, Veru's earnings do not currently justify its stock price, suggesting that the market may be factoring in future growth expectations or potential scientific breakthroughs.
The company's revenue has seen a significant decline of -58.59% over the last twelve months as of Q4 2023, which investors should consider when evaluating the company's growth prospects. Moreover, the InvestingPro Tips highlight that analysts do not anticipate Veru will be profitable this year and that the stock has exhibited high price volatility, which may indicate a higher risk profile for potential investors.
Those interested in a deeper dive into Veru's financials and stock performance can find additional insights and tips on InvestingPro. For instance, there are tips regarding the stock's poor performance over various time frames and its trading at a high revenue valuation multiple. In total, there are 13 additional InvestingPro Tips available for Veru, which can be accessed by investors looking to make an informed decision on the stock. To benefit from these insights, use the coupon code SFY24 to get an additional 10% off a 2-year InvestingPro+ subscription, or SFY241 to get an additional 10% off a 1-year InvestingPro+ subscription.
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