GLP-1 RA

Fractyl Health's Novel Smart GLP-1 Gene Therapy Shows Promise for Diabetes and Obesity Treatment

5 days ago

• Fractyl Health's RJVA-001, a single-dose pancreatic gene therapy, demonstrated durable metabolic improvements in diabetic mouse models with significantly lower systemic GLP-1 exposure than conventional GLP-1 drugs. • The therapy mimics natural hormone regulation through nutrient-responsive GLP-1 secretion from pancreatic beta cells, potentially addressing durability, adherence, and tolerability challenges seen with current GLP-1 medications. • Endoscopic ultrasound-guided delivery achieved targeted pancreatic expression with no observed toxicity in large animal models, positioning RJVA-001 for first-in-human studies with CTA submission expected by June 2025.

Weight Loss Injections Show Promising Anti-Cancer Effects Beyond Weight Reduction

11 days ago

• Research presented at the European Congress on Obesity suggests weight loss injections may reduce obesity-related cancer risk by nearly 50%, potentially through anti-inflammatory mechanisms beyond simple weight reduction. • Scientists from the University of Manchester are designing a large-scale clinical trial involving tens of thousands of patients to further investigate GLP-1 agonists as cancer prevention tools. • Experts believe these findings could herald a "new dawn" in preventative cancer medicine, potentially benefiting even non-obese individuals with high cancer risk factors.

GLP-1 Receptor Agonists Show Promise in Secondary Prevention of Atrial Fibrillation

23 days ago

• New data from the TRANSFORM-AF study suggests GLP-1 receptor agonists may reduce the risk of recurrent atrial fibrillation events by approximately 13% in patients with obesity and type 2 diabetes. • Patients with severe obesity (BMI >40 kg/m²) appeared to derive the greatest benefit from GLP-1 therapy, despite only modest differences in weight loss between treatment groups. • Researchers propose that GLP-1 receptor agonists could complement conventional AF therapies, potentially addressing the metabolic component of atrial fibrillation that contributes to disease progression.

American Heart Association Awards $1M to Study GLP-1 Medications' Impact on Cardiovascular Risk

23 days ago

• The American Heart Association has funded seven research projects with $1 million to identify which patients with obesity and cardiovascular disease benefit most from GLP-1/GIP medications. • Research teams from seven prestigious institutions will investigate biological, clinical, and social factors influencing treatment response, using the AHA's Precision Medicine Platform for data analysis. • Studies will examine how GLP-1/GIP medications affect cardiovascular outcomes across different populations, with aims to develop more personalized treatment approaches and address health disparities.

Hebe Biotechnology Appoints Dr. Hannes Hentze as CDO to Advance Novel GLP-1 Weight Loss Therapy

a month ago

• Singapore-based Hebe Biotechnology has appointed Dr. Hannes Hentze as Chief Development Officer to lead their next-generation GLP-1 receptor agonist program for weight management. • Dr. Hentze brings over 20 years of pharmaceutical development experience across academic research, biotech ventures, and large pharmaceutical companies, most recently serving at EDDC (A*STAR). • Preclinical data indicates Hebe Bio's GLP-1 RA therapy demonstrates superior efficacy and tolerability, with potential advantages in preserving muscle mass while optimizing fat loss compared to existing treatments.

Novo Nordisk Invests $1.09 Billion to Expand GLP-1 Production Capacity in Brazil

a month ago

• Novo Nordisk has committed $1.09 billion to expand its Montes Claros facility in Brazil, adding aseptic production processes, a warehouse, and a quality control laboratory to boost GLP-1 receptor agonist production. • The expansion, one of the largest pharmaceutical investments in Brazil's history, will create 600 permanent jobs and is expected to begin operations in 2028 to meet growing global demand for semaglutide products. • The facility will be designed with sustainability features including 100% solar power, water conservation strategies, and low-carbon construction materials, targeting LEED certification.

Ozempic Significantly Improves Walking Distance in Patients with Type 2 Diabetes and Peripheral Artery Disease

2 months ago

• Phase 3 STRIDE trial results show Ozempic (semaglutide) 1 mg increased maximum walking distance by 13% compared to placebo in patients with type 2 diabetes and peripheral artery disease. • Patients treated with semaglutide experienced a clinically meaningful median improvement of 26.4 meters in walking distance on a 12% incline, along with better pain-free walking and quality of life measures. • Based on these positive findings, Novo Nordisk has submitted a label extension application to the FDA, potentially making Ozempic the first new medication in over two decades to improve functional outcomes in PAD patients.

HUTCHMED Reports 65% Growth in Oncology Products Revenue, Achieves Profitability in 2024

2 months ago

• HUTCHMED achieved net income of $37.7 million in 2024, reaching profitability ahead of schedule with strong oncology products revenue growth of 65% to $271.5 million. • FRUZAQLA® (fruquintinib) demonstrated impressive global commercial performance with ex-China in-market sales of $290.6 million in its first full year, triggering sales milestone payments from Takeda. • The company is advancing its innovative ATTC (Antibody-Targeted Therapy Conjugate) platform and progressing multiple pipeline candidates, including positive data for savolitinib in NSCLC and sovleplenib for ITP.

Bloom Science and Ascletis Report Promising Results in Obesity Treatment Trials

2 months ago

• Bloom Science's obesity therapy, designed to mimic ketogenic diet effects, demonstrated sustained weight loss in 80% of patients for two weeks after final dosing, coinciding with World Obesity Care Week. • Ascletis Pharma's once-daily oral small molecule GLP-1 receptor agonist achieved a 6.3% reduction in body weight after 28 days in Phase Ib trials, while their muscle-preserving weight loss therapy maintains a 40-day half-life. • These developments emerge as Novo Nordisk prepares for a new Phase III trial of CagriSema, positioned as a potential successor to their successful Wegovy obesity medication.

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.

Aardvark Therapeutics Files for $100M IPO to Advance Novel Hyperphagia Treatment

4 months ago

• Aardvark Therapeutics has filed for a $100 million IPO on NASDAQ, seeking to advance its Phase III drug candidate ARD-101 for treating hyperphagia in Prader-Willi syndrome. • The company's lead candidate ARD-101 is an oral gut-restricted small molecule that works by inhibiting bitter taste receptors, with Phase III trial results expected in early 2026. • Aardvark plans to expand ARD-101's clinical development to include Phase II trials for hyperphagia associated with acquired hypothalamic obesity from craniopharyngioma treatment.

Ascletis' Oral GLP-1RA ASC30 Shows Promising Results in Obesity Trials

4 months ago

• Ascletis Pharma's ASC30, a novel oral GLP-1 receptor agonist, demonstrated dose-proportional pharmacokinetics and a long half-life of up to 60 hours in a Phase Ia study. • Interim Phase Ib results showed a 6.3% mean body weight reduction after 28 days, suggesting potential best-in-class characteristics for obesity treatment. • ASC30 was generally well tolerated, with mainly mild to moderate gastrointestinal-related adverse events and no serious adverse events reported. • Ascletis anticipates topline results from the Phase Ib multiple ascending dose trial by the end of March 2025, evaluating weight loss, safety, and pharmacokinetics.

GLP-1 Agonists Linked to Reduced Risk of 42 Health Conditions in Large Study

4 months ago

• A large observational study of nearly 2 million patients found that GLP-1 receptor agonists (GLP-1RAs) are associated with a reduced risk of 42 health conditions. • The study, which included 215,000 GLP-1RA users, showed benefits beyond glucose control and weight loss, including neurological and respiratory conditions. • While GLP-1RAs demonstrated broad benefits, the study also identified increased risks for certain conditions like kidney stones and low blood pressure. • Researchers emphasize the need for further studies to confirm these findings and understand the long-term effects of GLP-1RA therapy.

Metsera Aims for $289 Million IPO to Advance GLP-1RA Obesity Treatment

4 months ago

• Metsera is seeking a $289 million IPO to fund the Phase III trial of its lead candidate, MET-097i, an injectable GLP-1 receptor agonist for obesity. • MET-097i demonstrated up to 20% weight loss in Phase II trials, showcasing a long half-life that could allow for less frequent injections. • The company is also advancing other pipeline candidates, including MET-233i (ultra-long acting injectable) and MET-002 (oral GLP-1RA), to address the growing obesity market. • Metsera's IPO is viewed as a positive sign for the biopharma fundraising landscape, potentially catalyzing other companies to enter the public markets.

MBX Biosciences' MBX 1416 Shows Promise in Phase 1 Trial for Post-Bariatric Hypoglycemia

4 months ago

• MBX Biosciences announced positive topline results from its Phase 1 trial of MBX 1416 in healthy volunteers, indicating a favorable safety profile. • The trial supports once-weekly dosing of MBX 1416, with a median half-life of approximately 90 hours observed in the multiple ascending dose cohort. • MBX 1416 appeared to increase GLP-1 levels within 60 minutes of a mixed meal tolerance test, suggesting potential therapeutic benefits for PBH patients. • A Phase 2 study in patients with post-bariatric hypoglycemia is anticipated to begin in the second half of 2025, pending FDA alignment on study design.

Emerging Biotechs Vie for Position in Lucrative GLP-1RA Market Dominated by Novo Nordisk and Eli Lilly

5 months ago

• Altimmune's pemvidutide, currently in Phase II trials for obesity and metabolic dysfunction-associated steatohepatitis, is projected to reach $1.21 billion in sales by 2030. • Structure Therapeutics' GSBR-1290, an oral formulation in Phase II for obesity and type 2 diabetes, is forecasted to generate $1.2 billion in sales by 2030. • Viking Therapeutics, Altimmune, and Structure Therapeutics are emerging as potential disruptors in the GLP-1RA market, challenging the dominance of industry giants like Novo Nordisk and Eli Lilly.

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 Receptor Agonists and SGLT2 Inhibitors Show Promise in Cardio-Renal Protection

5 months ago

• Vadadustat (Vafseo) was approved by the FDA for treating anemia caused by chronic kidney disease (CKD) in adults on dialysis for at least 3 months. • Combination therapy with GLP-1 receptor agonists (GLP-1RAs) and SGLT2 inhibitors reduces CKD by 33% and slows kidney function loss by nearly 60%. • Semaglutide shows benefits in treating CKD and cardiovascular events in patients with type 2 diabetes, according to the FLOW randomized trial. • GLP-1s may improve cardiovascular outcomes and promote weight loss in breast cancer patients, according to research presented at ASCO.

Biophytis Presents BIO101 Obesity Program Data at SCWD International Congress, Plans Phase 2 Trial

5 months ago

• Biophytis presented its OBA program featuring BIO101 (20-hydroxyecdysone) at the 17th SCWD International Congress, highlighting its potential to mitigate muscle loss induced by GLP-1RA therapies in obese patients. • Clinical data from the Quinolia study demonstrated that 20-hydroxyecdysone reduced fat mass and maintained muscle strength in overweight and obese individuals on a hypocaloric diet. • A subgroup analysis from the SARA-INT study suggested BIO101 could improve muscle function in sarcopenic obese patients, showing statistically significant improvement in the 400-meter walking speed test. • Biophytis plans to initiate a Phase 2 OBA study in early 2025 to assess BIO101's efficacy and safety in obese patients undergoing treatment with GLP-1 RAs like Semaglutide or Wegovy.

Drug Development Updates