Veru Inc
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 189
- Market Cap
- $122.9M
- Introduction
Veru, Inc. is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 clinical trial of enobosarm for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting. Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The company was founded by William R. Gargiulo, Jr., O. B. Parrish, and Harry Fisch in 1971 and is headquartered in Miami, FL.
Allogene's ALLO-329 Receives FDA IND Clearance for Autoimmune Disease Trial
• The FDA has cleared Allogene Therapeutics' IND application for ALLO-329, a dual-targeting allogeneic CAR T-cell therapy, to treat autoimmune diseases.
• The Phase 1 RESOLUTION trial, planned for mid-2025, will assess ALLO-329's safety and efficacy in systemic lupus erythematosus, idiopathic inflammatory myopathies, and systemic sclerosis.
• ALLO-329 targets both CD19+ B cells and CD70+ activated T cells and incorporates Allogene's Dagger® technology to potentially reduce or eliminate lymphodepletion.
• The trial will evaluate two lymphodepletion arms, one using cyclophosphamide and another eliminating lymphodepletion, to demonstrate the Dagger® effect.
Veru's Enobosarm Shows Promise in Phase IIb Trial for Enhanced Weight Management
• Phase IIb QUALITY trial demonstrates significant improvements in lean mass retention and fat loss when combining enobosarm with semaglutide, compared to placebo.
• The study reports 80.6% of treated patients maintained stair climb power near baseline, indicating enhanced functional benefits particularly relevant for older populations.
• Higher 6mg dose of enobosarm showed superior improvements in fat loss metrics, prompting plans for Phase III program development.
FDA Approves Monthly Maintenance Dosing for Leqembi in Early Alzheimer's Treatment
The FDA has granted approval for monthly maintenance dosing of Leqembi (developed by Eisai and Biogen) for early Alzheimer's disease patients. After 18 months of bi-weekly treatment, patients can transition to monthly dosing at half the original dose, based on Phase 2 study results and modeling simulations demonstrating sustained therapeutic benefits.
Veru's Enobosarm Preserves Lean Mass in Patients on Wegovy for Weight Loss
• Veru's enobosarm significantly reduced lean mass loss in older, overweight or obese patients taking Wegovy, a GLP-1 receptor agonist, in a Phase 2b trial.
• Patients on enobosarm plus Wegovy lost 1.2% of lean mass compared to 4.1% in the Wegovy-only group, demonstrating a statistically significant benefit in lean mass preservation.
• Enobosarm treatment also resulted in greater fat mass reduction and improved physical function, as measured by a stair climb test, compared to placebo plus Wegovy.
• Veru plans to meet with the FDA to discuss advancing enobosarm to Phase 3 trials, focusing on a 52-week study with stair-climb power as the primary endpoint.
Veru's Enobosarm Shows Promise in Preserving Muscle Mass During Weight Loss with GLP-1 RAs
• Veru Inc. announced positive topline results from its Phase 2b QUALITY study, where enobosarm significantly reduced lean mass loss in patients on WEGOVY.
• Patients on enobosarm lost 71% less lean mass and 27% more fat mass compared to those receiving WEGOVY alone, indicating improved body composition.
• The study met its primary endpoint, showing a statistically significant benefit in preserving total lean body mass with enobosarm plus semaglutide versus placebo plus semaglutide.
• Veru plans to meet with the FDA to discuss the design of a Phase 3 clinical program based on these promising results.
Novo Nordisk's Amycretin Shows Promising Weight Loss in Phase 1b/2a Trial
• Novo Nordisk's amycretin, a GLP-1 and amylin receptor agonist, demonstrated significant weight loss in a Phase 1b/2a trial.
• Participants on the highest dose of subcutaneous amycretin (20mg) experienced an average 22% body weight loss over 36 weeks.
• The safety profile of amycretin was consistent with incretin-based therapies, with mainly mild to moderate gastrointestinal adverse events.
• Novo Nordisk plans further clinical development of amycretin for adults with overweight or obesity, based on these encouraging results.
Akero's Efruxifermin Shows Promise in Reversing Cirrhosis Due to MASH in Phase 2b Trial
• Akero Therapeutics' Efruxifermin (EFX) demonstrated statistically significant cirrhosis reversal in patients with MASH in a Phase 2b trial.
• In patients with baseline and week 96 biopsies, 39% treated with 50mg EFX showed cirrhosis reversal without worsening MASH, compared to 15% with placebo.
• The SYMMETRY study underscores the benefit of longer EFX treatment, showing a doubling of effect size from weeks 36 to 96 in the 50mg group.
• Akero is continuing to evaluate 50mg EFX in the Phase 3 SYNCHRONY Outcomes study for patients with compensated cirrhosis due to MASH.
Veru Inc. Initiates Phase 2b Trial of Enobosarm for Sarcopenic Obesity and Sells FC2 Business
• Veru Inc. has commenced its Phase 2b QUALITY trial, evaluating enobosarm combined with semaglutide for sarcopenic obesity, with 168 patients enrolled.
• The QUALITY trial is a multicenter, double-blind, placebo-controlled study assessing enobosarm's safety and efficacy in preserving muscle and augmenting fat loss in elderly patients.
• Veru Inc. sold its FC2 Female Condom business for US$18 million to Riva Ridge Capital Management, aiming to focus on biopharmaceutical development.
• The sale is projected to provide approximately US$12.5 million in proceeds, strengthening Veru's financial position for clinical trials of enobosarm.
Novavax Launches Clinical Trial for JN.1 Subvariant COVID-19 Vaccine
Novavax initiates a new clinical trial to evaluate the safety and immunogenicity of its JN.1 subvariant vaccine (NVX CoV2705) with Matrix-M adjuvant. The study will compare results with the previously authorized NVX-CoV2601 vaccine, marking a significant step in addressing emerging COVID-19 variants.
GLP-1 Agonist Market Set for Exponential Growth, Fueled by Novel Therapies and Expanding Indications
• The GLP-1 agonists market is projected to experience substantial growth by 2034, driven by increased awareness and efficacy in managing diabetes and obesity.
• Key players like Novo Nordisk, AstraZeneca, and Viking Therapeutics are developing innovative GLP-1 agonists, including oral formulations, to enhance patient adherence.
• Emerging therapies such as VK2735, TERN-601, and ECC5004 are poised to transform the market with improved efficacy and novel mechanisms of action.
• GLP-1 agonists are gaining traction beyond diabetes, showing promise in treating obesity and non-alcoholic fatty liver disease (NAFLD), expanding their therapeutic potential.
Weight Loss Drug Race Heats Up: Zepbound Outperforms Wegovy, New Therapies Target Muscle Growth
• Eli Lilly's Zepbound demonstrated superior weight loss compared to Novo Nordisk's Wegovy in a head-to-head trial, with Zepbound users losing over 20% of body weight versus Wegovy's under 14%.
• Several companies, including Eli Lilly, Regeneron, and Veru, are developing new weight loss drugs that aim to preserve or promote muscle growth, addressing concerns about muscle loss with existing GLP-1 therapies.
• The obesity treatment market is experiencing rapid growth and innovation, with over 300 GLP-1R drugs in development and analysts projecting sales to potentially reach $150 billion annually by the early 2030s.
• Upcoming trial readouts in 2025 from companies like Metsera, Skye Bioscience, and Eli Lilly may introduce novel mechanisms and improved convenience, further intensifying competition in the obesity market.
Veru's Enobosarm Shows Potential in Meta-Analysis to Optimize Weight Loss by Preserving Muscle
• A meta-analysis of four randomized clinical trials suggests that enobosarm may optimize weight loss by preserving muscle mass.
• Veru Inc. is conducting a Phase 2b trial to evaluate enobosarm's safety and efficacy in sarcopenic obese or overweight elderly patients receiving semaglutide.
• Topline results from the Phase 2b trial are expected in January 2025, with extension study results anticipated in Q2 2025.
• Enobosarm has a large safety database of 27 clinical trials involving 1581 men and women and was generally well tolerated with no increases in gastrointestinal side effects.
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