Veru Reports Fiscal 2025 Second Quarter Financial Results and Clinical Program Progress

--Unblinded safety data from Phase 2b QUALITY study expected in the second quarter of calendar 2025 --

--Topline efficacy and safety data for Phase 2b extension maintenance study expected in the second quarter of calendar 2025 --

--With positive Phase 2b QUALITY study, Veru plans for end of Phase 2 meeting with FDA to discuss Phase 3 clinical program --

--Company to host conference call and webcast today at 8:00 a.m. ET--

MIAMI, FL, May 08, 2025 (GLOBE NEWSWIRE) -- Veru Inc. $(VERU)$, a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for its fiscal 2025 second quarter and provided an update on progress of its clinical development programs.

"In addition to our previously disclosed robust and exciting topline efficacy data from the enobosarm Phase 2b QUALITY study, we are now looking forward to the near-term Company catalysts this calendar quarter including the unblinded safety data from the enobosarm Phase 2b QUALITY study as well as the topline efficacy and safety data from the Phase 2b extension maintenance study. The Phase 2b extension study should show us what happens to patients when they stop GLP-1 receptor agonist treatment but remain on enobosarm. The treatment objective is for patients to have a healthier option for choosing to stop GLP-1s without the fear of fat regain," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "We also expect to submit our End of Phase 2 meeting request to FDA. We anticipate that the End of Phase 2 FDA meeting will provide regulatory clarity for the Phase 3 clinical program and should occur in the third quarter of calendar 2025."

Positive Phase 2b QUALITY clinical study: Enobosarm in combination with GLP-1 RA drugs makes weight reduction more tissue selective for fat loss while preserving lean mass and physical function.

In January 2025, the Company announced positive topline results from the Phase 2b QUALITY clinical study which is a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in older (>=60 years of age) patients receiving semaglutide (Wegovy$(R)$ ) for chronic weight management.

Topline Results

In the topline efficacy analysis, the trial met its prespecified primary endpoint with a statistically significant and a clinically meaningful benefit in all patients receiving enobosarm + semaglutide versus placebo + semaglutide at 16 weeks in total lean mass (71% relative reduction in lean mass loss, p=0.002). Notably, the enobosarm 3mg + semaglutide was the best dose with a >99% mean relative reduction in loss of lean mass (p <0.001). Enobosarm 6mg + semaglutide dose was not better than the Enobosarm 3mg + semaglutide dose on lean mass.

Topline Secondary Endpoints

Enobosarm + semaglutide treatment resulted in dose dependent greater loss of fat mass compared to placebo + semaglutide with the enobosarm 6mg dose having a 46% greater relative loss of fat mass compared to placebo + semaglutide group at 16 weeks (p=0.014). Although enobosarm + semaglutide significantly preserved lean mass, the additional loss of fat mass caused by enobosarm treatment was able to replace the lean mass preserved to allow a similar net mean weight loss with semaglutide at 16 weeks. Accordingly, the tissue composition of the total weight loss shifted to greater and selective loss of fat with enobosarm treatment. The median percentage of total body weight loss in the placebo + semaglutide group that was due to lean mass was 32% and estimated fat loss was 68%. In contrast, in the all enobosarm + semaglutide group, the total weight loss due to lean mass was 9.4% vs estimated fat loss of 90.6%, and for the enobosarm 3mg + semaglutide group, it was 0.9% lean mass vs 99.1% estimated fat loss. Therefore, enobosarm + semaglutide improved changes in body composition resulting in more selective and greater loss of adiposity than in subjects receiving placebo + semaglutide.

Physical Function

Physical function was measured by the Stair Climb Test. Climbing stairs is an activity of daily living, and the Stair Climb Test measures functional muscle strength, balance and agility. Declines in performance measured by Stair Climb Test predicts in older patients a higher risk for mobility disabilities, gait difficulties, falls and bone fractures, hospitalizations, and mortality. As a point of reference, stair climb power declines by -1.38% annually with aging according to Van Roie E. PLOS ONE 14:e0210653, 2019.

   -- Phase 2b QUALITY clinical trial is the first human study to demonstrate 
      that older patients who are overweight or have obesity receiving 
      semaglutide GLP-1 RA are at higher risk for accelerated loss of lean mass 
      with physical function decline. A responders analysis was conducted using 
      a greater than 10% decline in stair climb power as the cut off at 16 
      weeks which represents an approximate 7 to 8 year loss of stair climb 
      power that naturally occurs with aging. In our study, the loss of lean 
      mass mattered as 42.6% of patients on placebo + semaglutide group had at 
      least a 10% decline in stair climb power physical function at 16 weeks. 
   -- Enobosarm treatment preserved lean mass (muscle) which translated into a 
      reduction in the proportion of patients that had a clinically significant 
      stair climb physical function decline versus subjects receiving 
      semaglutide alone. The all enobosarm + semaglutide group had a 
      statistically significant and clinically meaningfully 54.4% mean relative 
      reduction in the proportion of subjects that lost at least 10% stair 
      climb power compared to placebo + semaglutide group (p=0.0049). In 
      enobosarm 3mg + semaglutide, there was a 62.4% relative reduction in the 
      proportion of patients with at least a 10% decline in stair climb power 
      from baseline vs. placebo + semaglutide group (p=0.0066). In enobosarm 
      6mg + semaglutide, there was a 46.2% relative reduction in the proportion 
      of patients with at least a 10% decline in stair climb power from 
      baseline vs. placebo + semaglutide group (p=0.0505). 

Topline Results Conclusion

Enobosarm represents a novel drug that improves GLP-1 RA therapy resulting in tissue SELECTIVE quality weight reduction, that is, enobosarm + semaglutide improved changes in body composition which resulted in more selective and greater loss of adiposity (fat mass) than in subjects receiving placebo + semaglutide alone.

Phase 2b QUALITY Clinical Trial Safety

Safety data for the Phase 2b QUALITY study remains blinded as the Phase 2b extension clinical study portion is ongoing. The unblinded Phase 2b QUALITY clinical trial safety will be available this quarter. However, to the Company's knowledge, the aggregate, blinded safety data have to date not shown any significant differences compared to what is expected based on previous studies of enobosarm or GLP-1 RAs.

Phase 2b Extension Maintenance Study

After completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial, the participants continued into a Phase 2b extension trial where all patients have stopped treatment with semaglutide, but continued taking placebo, enobosarm 3mg, or enobosarm 6mg in a blinded fashion for 12 weeks. The Phase 2b extension clinical trial is evaluating whether enobosarm can maintain muscle and prevent the fat regain that generally occurs after discontinuing a GLP-1 RA. The topline efficacy and safety results for the Phase 2b extension clinical study are expected this quarter.

Regulatory Next Steps

As the Phase 2b QUALITY clinical trial is a positive study, we plan to request an End of Phase 2 meeting with the FDA. During the preIND FDA meeting, FDA provided general comments about a regulatory path forward for enobosarm as a drug that improves body composition during weight loss including input on Phase 3 clinical program design.

As a path forward, we plan to propose a Phase 3 clinical program that is similar to the positive Phase 2b QUALITY clinical trial. The proposed Phase 3 clinical trial design is a double-blind, placebo-controlled study in older patients, greater than or equal to 60 years of age, who have obesity or who are overweight and who are eligible for treatment with GLP-1 RA. The GLP-1 RA may be either WEGOVY (semaglutide) and/or Zepbound(R) (tirzepatide). Patients will be randomized to oral daily enobosarm or matching placebo. All subjects will start and receive GLP-1 RA during the study. The proposed primary objective will be the effect of enobosarm on physical function measured by the Stair Climb Test at 24 weeks. Proposed key secondary objectives will be to assess the effect of enobosarm on total lean mass, total fat mass, HOMA-IR, and hemoglobin A1c at 24 weeks.

After the Phase 3 clinical trial ends at 24 weeks of treatment, the plan is to continue to measure total lean mass, total body weight, stair climb, total fat mass, bone mineral density, HOMA-IR, and hemoglobin A1c up to 68 weeks to capture the longer-term benefits of enobosarm improvements on body composition for greater loss of adiposity or fat, weight reduction, and preservation of both lean mass and bone.

Novel Modified Release Oral Enobosarm Formulation is on Track to be Available for Phase 3 Clinical Studies and Commercialization

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