Enobosarm

Allogene's ALLO-329 Receives FDA IND Clearance for Autoimmune Disease Trial

4 months ago

• 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 Muscle Preservation During GLP-1 Weight Loss, Despite Market Skepticism

4 months ago

Phase 2b QUALITY trial demonstrates that Veru's enobosarm significantly reduces lean muscle mass loss in older adults taking GLP-1 agonists for weight loss. Despite achieving its primary objective of muscle preservation, Veru's shares dropped nearly 48% as fat mass reduction data failed to reach statistical significance compared to Wegovy alone.

Helicore Biopharma Launches with $65M to Target GIP for Improved Weight Loss

4 months ago

• Helicore Biopharma, backed by Versant Ventures and OrbiMed, launches with $65 million in Series A funding to develop GIP-targeting therapies for obesity. • The lead asset, HCR-188, a monoclonal antibody against GIP, is expected to enter clinical trials this year, with topline data anticipated in late 2025. • Helicore aims to differentiate itself through GIP antibody conjugates, potentially combined with GLP-1 therapies, to target specific obesity subpopulations. • Preclinical data suggest HCR-188, especially with GLP-1 therapies, may induce preferential fat loss over lean mass, addressing a key challenge in obesity treatment.

Veru's Enobosarm Shows Promise in Phase IIb Trial for Enhanced Weight Management

4 months ago

• 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

4 months ago

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

4 months ago

• 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

4 months ago

• 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

4 months ago

• 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

4 months ago

• 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.

AI-Driven Discovery Unveils Cancer Therapy Breakthrough

4 months ago

Rakovina Therapeutics Inc. has synthesized groundbreaking AI-designed drug candidates targeting critical cancer treatments, potentially reshaping oncology research.

Veru Inc. Initiates Phase 2b Trial of Enobosarm for Sarcopenic Obesity and Sells FC2 Business

5 months ago

• 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.

GLP-1 Agonist Market Set for Exponential Growth, Fueled by Novel Therapies and Expanding Indications

5 months ago

• 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

6 months ago

• 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

7 months ago

• 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.

Obesity Drug Race Heats Up: Cagrisema, MariTide, and Zepbound Vie for Dominance

7 months ago

• Eli Lilly's Zepbound is being directly compared to Novo Nordisk's Wegovy in the SURMOUNT-5 trial, with results expected by year-end, potentially impacting market perception. • Novo Nordisk's cagrisema, a dual-acting drug combining semaglutide and amylin, is in Phase 3 trials, aiming to challenge Zepbound and Wegovy's market share. • Amgen's MariTide, a monthly injectable targeting GLP-1 and GIP, is showing promise in Phase 2 trials, with results anticipated by the end of the year. • Companies are also exploring obesity pills and muscle-preserving strategies to improve treatment outcomes and patient adherence.

Drug Development Updates