Veru Reports Muscle Data from 5 Clinical Studies of Enobosarm that Support the Advancement of Enobosarm in Combination with Weight-Loss GLP-1 Drugs, Ozempic®, Wegovy®, or Mounjaro®, to Optimize Weight Loss by Preventing Muscle Wasting and Further Incr...

Veru Reports Muscle Data from 5 Clinical Studies of Enobosarm that Support the Advancement of Enobosarm in Combination with Weight-Loss GLP-1 Drugs, Ozempic®, Wegovy®, or Mounjaro®, to Optimize Weight Loss by Preventing Muscle Wasting and Further Increasing Fat Loss in a Phase 2b Obesity Clinical Study

-- In 5 clinical studies involving 968 older men and postmenopausal women with and without muscle wasting, enobosarm has demonstrated the ability to decrease fat mass, increase muscle mass, and improve muscle strength and physical function --

-- Weight-loss drugs like Ozempic, Wegovy, Mounjaro and other GLP-1 drugs cause a significant loss of both fat and muscle; in older obese or overweight patients who may already have low muscle mass, the further drop in muscle mass of all-important muscles increases risk of muscle weakness, functional limitations, mobility disability, falls, higher hospitalizations, and greater mortality --

-- The Company plans to conduct a Phase 2b double-blind, placebo-controlled study to evaluate enobosarm and GLP-1 drug combination for weight loss to prevent muscle loss and to preferentially increase fat loss in patients who are overweight or have obesity --

-- Phase 2b clinical obesity study to be open for enrollment as early as calendar Q1 2024 --

MIAMI, FL, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of obesity, breast cancer and for viral induced ARDS, today announced that the Company will advance its proprietary novel agent, enobosarm, a selective androgen receptor modulator (SARM), into a Phase 2b clinical trial in combination with weight-loss GLP-1 drugs, Ozempic (semaglutide), Wegovy (semaglutide), or Mounjaro (tirzepatide) to evaluate the efficacy and the safety of enobosarm to further increase fat loss while preventing the significant muscle wasting that occurs with weight-loss GLP-1 drugs.

Weight loss from these medications results from the collective loss of fat mass and lean mass (muscle and bone). Muscle is critical for metabolism, muscle strength and physical function (mobility) and prevention of injury (falls) especially in an older population. According to the CDC, 42% of older adults have obesity and could benefit from weight loss medication, but the high amount of muscle wasting that occurs with weight-loss drugs reduces the muscle mass to sarcopenic, or critically low amounts, which may result in muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures, higher hospitalizations, and increased mortality. Up to 30% of older obese patients have sarcopenic obesity, which means they have both obesity and age-related low muscle mass at the same time and are potentially at the greatest risk for developing critically low muscle mass and muscle weakness and functional limitations when taking weight-loss GLP-1 drugs.

In a study by Wilding et al. reported in The New England Journal of Medicine, a subgroup analysis was conducted in 140 subjects from the Obesity (STEP 1) Trial which evaluated semaglutide 2.4 mg a week treatment compared to placebo for 68 weeks. In this analysis, semaglutide treatment resulted in the average loss of 10.43 kg (22.9 lbs) of fat and 6.92 kg (15.2 lbs) of muscle mass which means that muscle loss made up 40% of the total weight lost. Similarly, Sargeant et al. observed that treatment with GLP-1 receptor agonists and sodium glucose cotransporter 2 inhibitors (SGLT2i) resulted in muscle loss that made up 20-50% of the total weight lost.

Enobosarm treatment consistently prevents loss of muscle across 5 clinical studies (see Table)

Enobosarm is an oral, new chemical entity, new class, selective androgen receptor targeting agent or modulator (SARM) that has demonstrated tissue-selective, dose-dependent increases in muscle mass (lean body mass), reduces fat mass, improves insulin resistance, while sparing other androgenic tissue with no masculinizing effects in women, with prostate neutral effects in men and without increases in hematocrit. Increases in muscle mass have resulted in improvements in muscle strength and physical function. In preclinical studies in male and female mice, enobosarm demonstrated the ability to prevent and treat bone loss. Enobosarm has extensive nonclinical and clinical experience having been evaluated in 25 separate clinical studies in approximately 1,500 subjects dosed. Five clinical studies for a total of 968 patients measured muscle mass endpoints, including two Phase 2 clinical studies in healthy older or sarcopenic subjects (168 subjects) and one Phase 2b and two Phase 3 studies in subjects with muscle wasting because of cancer (800 subjects). Muscle wasting caused by cancer creates a “starvation state” where there is significant loss of both lean body mass and fat mass which is similar to what has been observed with starvation and weight loss GLP-1 drugs. Enobosarm treatment in elderly men and postmenopausal women with and without active muscle wasting consistently resulted in the reduction in fat mass and significant increases in lean body mass (muscle) with improvements muscle strength and physical function. Enobosarm has a large safety database and was generally well tolerated and safe in both men and women.

Table:Veru has clinical data: 5 clinical studies in 968 older subjects with and without muscle wasting