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Pop early IMO..

Watch this one for a pop. they released news of going into phase 2 trials right at post market close.
-- The Phase 2b study planned to be conducted in 15 clinical sites in the United States --

-- Topline clinical data expected in the fourth quarter calendar year 2024 --
MIAMI, FL, April 30, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that it has enrolled the first patients in its Phase 2b clinical trial of enobosarm, an oral selective androgen receptor modulator (SARM), to avoid muscle loss and to augment fat loss when combined with semaglutide (Wegovy®), a Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drug, for potentially higher quality weight loss. Topline clinical data is expected in the fourth quarter of the calendar year 2024.
"We are excited to enroll the first patients in the Phase 2b clinical trial, marking an important milestone in the development of enobosarm for high quality weight loss," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. "There is a significant unmet medical need to have a drug that may effectively preserve muscle in patients undergoing weight loss therapy with GLP-1 drugs. Patients receiving GLP-1 drugs lose significant muscle as part of the weight loss which can lead to muscle weakness in older patients with both obesity and low muscle reserves. Muscle weakness is associated with mobility disability and loss of balance resulting in a higher risk for falls and hip and pelvic fractures. In fact, the package insert for Wegovy® has been updated based on the recently reported SELECT (Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity) cardiovascular outcomes clinical trial to highlight the four-fold increase in pelvic and hip fractures that was observed in patients greater than 75 years of age receiving Wegovy® compared to placebo."
"While there is clear medical benefit from weight loss with semaglutide, improving weight loss quality by minimizing the loss of lean mass is the next step forward in improving metabolic complications of obesity. This Phase 2b clinical trial of enobosarm will provide important insights into how this goal can be achieved," said Louis Aronne, MD, obesity medicine specialist at Weill Cornell Medicine in New York, Chief Medical Advisor to Veru*.
About the Enobosarm Phase 2b clinical trial

The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial was designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in approximately 90 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy®).The primary endpoint is difference in total lean body mass measured by DEXA, and the key secondary endpoints are differences in total body fat mass measured by DEXA and physical function as measured by stair climb test at 16 weeks. Topline clinical results from the trial are expected by the end of 2024.
After completing the efficacy dose-finding portion of the Phase 2b clinical trial, participants will then continue into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate Phase 2b extension clinical study are expected in calendar Q2 2025.
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