Survodutide
- Generic Name
- Survodutide
GSK Acquires Efimosfermin Alfa from Boston Pharmaceuticals in $2 Billion Deal for Liver Disease Treatment
• GSK has agreed to acquire efimosfermin alfa, a phase III-ready liver disease drug, from Boston Pharmaceuticals in a deal worth up to $2 billion.
• The acquisition includes an upfront payment of $1.2 billion, with potential for additional success-based milestone payments totaling $800 million.
• This strategic move strengthens GSK's pharmaceutical portfolio in the liver disease therapeutic area, addressing significant unmet medical needs.
MetaVia's Novel Dual Receptor Agonist Shows Promising 6.3% Weight Loss in Phase 1 Obesity Trial
• MetaVia's DA-1726, a 3:1 ratio GLP-1/glucagon dual receptor agonist, demonstrated maximum weight loss of 6.3% and mean reduction of 4.3% after just 26 days in Phase 1 trial without dose titration.
• The drug showed favorable safety profile with only mild, transient gastrointestinal side effects and no treatment discontinuations, potentially offering better tolerability than current GLP-1 agonists.
• Beyond weight loss, DA-1726 reduced waist circumference by up to 3.9 inches and lowered fasting glucose by up to 18 mg/dL, suggesting potential applications for type 2 diabetes and MASH patients.
WEGOVY's Market Dominance Grows with Expanded Cardiovascular Indication and Strong Clinical Results
• Novo Nordisk's WEGOVY has secured FDA approval for cardiovascular risk reduction in March 2024, becoming the first obesity medication authorized to reduce cardiovascular death, heart attack, and stroke risks.
• Phase IIIb STEP UP trial demonstrates superior efficacy of WEGOVY 7.2mg compared to 2.4mg dosage, showing significant weight loss benefits at 72 weeks in adults with obesity.
• WEGOVY generated impressive US sales of $6.4 billion in 2024, with market presence now extending to over 15 global markets including recent approval in Japan.
Viking Therapeutics Initiates Phase 2 Trial of Oral VK2735 for Obesity
• Viking Therapeutics has commenced a Phase 2 clinical trial for oral VK2735, a dual GLP-1/GIP agonist, to treat obesity.
• The VENTURE-Oral Dosing Trial will evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy over 13 weeks in approximately 280 adults.
• Prior Phase 1 data showed promising weight reductions up to 8.2% and encouraging tolerability with the oral tablet formulation of VK2735.
• Viking plans to initiate Phase 3 development for the subcutaneous formulation of VK2735 in the first half of 2025, following positive Phase 2 results.
Retatrutide Shows Promising Weight Loss Results Compared to Other GLP-1 Agonists
• A recent study shows retatrutide, an investigational triple agonist, led to a 22.1% weight loss over 48 weeks, surpassing existing GLP-1 drugs.
• Tirzepatide, commercially available as Zepbound, demonstrated a 17.8% weight loss over 72 weeks, highlighting its effectiveness in obesity management.
• Semaglutide (Wegovy) resulted in a 13.9% weight loss over 68 weeks, while liraglutide (Saxenda) showed a 5.8% reduction over 26 weeks.
• Oral semaglutide and orforglipron show promise in improving accessibility and adherence due to their non-injectable administration.
Boehringer Ingelheim Partners with Walgreens for Obesity and Diabetes Clinical Trial
Boehringer Ingelheim collaborates with Walgreens to leverage its community pharmacy network for a large-scale clinical trial targeting individuals with obesity, overweight, and type 2 diabetes. This partnership aims to enhance diversity and inclusivity in clinical trials, particularly among Black and Hispanic adults, by utilizing Walgreens' extensive reach and EmVenio Research's mobile units for hard-to-reach communities.
Hengrui Pharma's HRS9531 Shows Promising Weight Loss in Phase 2 Obesity Trial
• Hengrui Pharmaceuticals and Kailera Therapeutics reported positive Phase 2 results for HRS9531, a GLP-1/GIP receptor dual agonist, in overweight or obese adults.
• Participants receiving the 8 mg dose of HRS9531 achieved a statistically significant 21.1% placebo-adjusted mean weight loss at 36 weeks.
• The trial demonstrated a favorable safety profile, with most adverse events being mild and gastrointestinal-related during dose titration.
• Hengrui is advancing HRS9531 into Phase 3 clinical trials for obesity and type 2 diabetes in China, with Kailera developing it globally as KAI-9531.
Zealand Pharma and Eli Lilly Lead the Charge in Weight Loss Drug Development
• Zealand Pharma's survodutide, a unique anti-obesity molecule, is currently in Phase 3 trials, potentially offering a more effective or tolerable alternative for weight loss.
• Eli Lilly's Zepbound, a blockbuster weight-loss drug, reported $1.2 billion in third-quarter sales and is undergoing manufacturing expansion with a $3 billion investment.
• Lilly is also investing in expanding Zepbound's indications, with recent data showing a significantly lower risk of worsening heart failure in obese patients.
GLP-1 Therapies Expand Beyond Diabetes: Promising Results in Cardiovascular, Renal, and Liver Diseases
• Semaglutide shows a 20% reduction in major cardiovascular events in obese individuals without diabetes, according to the SELECT trial.
• The FLOW trial indicates semaglutide's efficacy in protecting renal function in type 2 diabetes patients with chronic kidney disease, reducing kidney-related events by 24%.
• Tirzepatide demonstrates potential in treating obstructive sleep apnea by reducing apnea episodes and promoting significant weight loss in clinical trials.
• Survodutide shows promise in treating metabolic dysfunction-associated steatohepatitis (MASH), with up to 67% of recipients experiencing a 30% or greater reduction in MASH symptoms.
NASH Treatment Market to Reach Significant Growth by 2032, Driven by Emerging Therapies
• The non-alcoholic steatohepatitis (NASH) market is poised for substantial growth, projected to expand significantly by 2032 across the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
• This growth is fueled by the introduction of novel therapies targeting NASH, with several drugs in Phase II and Phase III clinical trials showing promise for improving treatment outcomes.
• Key players such as Madrigal Pharmaceuticals, Intercept Pharmaceuticals, and Novo Nordisk are actively developing innovative treatments, contributing to a dynamic and competitive market landscape.
• The increasing prevalence of NASH and the growing understanding of its pathophysiology are driving the demand for effective therapies, creating opportunities for pharmaceutical companies.
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.
Zealand Pharma and Palatin Technologies Advance Obesity and Metabolic Disease Pipelines
• Zealand Pharma reported positive Phase 1b results for petrelintide and dapiglutide, advancing both into Phase 2b trials for overweight and obese patients.
• Boehringer Ingelheim's survodutide, a Zealand Pharma-partnered asset, showed positive Phase 2 results in MASH and progresses to Phase 3 trials.
• Palatin Technologies anticipates topline results from its Phase 2 BMT-801 trial of bremelanotide with tirzepatide for obesity in Q1 2025.
Semaglutide Shows Promise in MASH Treatment, Novo Nordisk Plans Filing
• Semaglutide demonstrated efficacy in resolving MASH and improving liver fibrosis in a Phase 3 trial, meeting primary endpoints.
• The ESSENCE trial showed a once-weekly 2.4mg dose of semaglutide was superior to placebo in treating MASH over 72 weeks.
• Novo Nordisk plans to file semaglutide for MASH in the US and Europe in the first half of next year, pending regulatory review.
• Semaglutide's potential approval for MASH could significantly boost its market, adding to its existing uses for diabetes and obesity.
Survodutide Receives FDA Breakthrough Therapy Designation for MASH, Phase III Trials Begin
• The FDA has granted Breakthrough Therapy designation to Boehringer Ingelheim's survodutide for adults with non-cirrhotic MASH and moderate to advanced fibrosis.
• Survodutide's designation is based on clinical data demonstrating potential improvement over existing therapies for MASH and advanced fibrosis.
• Boehringer Ingelheim has initiated two Phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, to evaluate the efficacy and safety of survodutide in MASH patients.
• Survodutide is a dual glucagon/GLP-1 receptor agonist, offering a novel approach to address the unmet medical need in MASH treatment.
Beyond Obesity: GLP-1 Drugs Show Promise in Addiction, Neurodegeneration, and More
• GLP-1 receptor agonists, initially developed for weight loss, are being investigated for their potential to curb cravings and addictions, including alcohol and tobacco use.
• Clinical trials suggest GLP-1 drugs may reduce the risk of cardiovascular events and kidney complications, potentially through mechanisms beyond weight loss, such as reducing inflammation.
• Research indicates GLP-1 drugs could ease symptoms of neurodegenerative diseases like Parkinson's and Alzheimer's by reducing brain inflammation and improving mitochondrial function.
• Studies are exploring the use of GLP-1 medications for various conditions, including depression, anxiety, and even fertility issues, highlighting the broad impact of these drugs.
Madrigal's Resmetirom Nears Full Approval for NASH Cirrhosis Treatment Following Phase 3 Enrollment Completion
• Madrigal Pharmaceuticals completed patient enrollment for its MAESTRO-NASH OUTCOMES trial, evaluating resmetirom for compensated NASH cirrhosis.
• The Phase 3 trial involves 845 patients and aims to measure the progression to liver decompensation events over two to three years.
• Positive outcomes from the trial could support full approval of Rezdiffra for noncirrhotic NASH and expand its indication to cirrhotic patients.
• Resmetirom, a liver-directed THR-β agonist, has already received accelerated approval for NASH with moderate to advanced liver fibrosis.
NeuroBo Pharmaceuticals Completes Enrollment in Phase 1 Trial of DA-1726 for Obesity
• NeuroBo Pharmaceuticals completed enrollment in the single ascending dose (SAD) Part 1 of its Phase 1 clinical trial of DA-1726 for obesity.
• The trial enrolled 45 participants randomized into five cohorts to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726.
• DA-1726 is a novel, dual oxyntomodulin analog agonist targeting both GLP-1 and glucagon receptors, showing promise in preclinical studies.
• Top-line data from SAD Part 1 is expected in Q3 2024, with MAD Part 2 results anticipated in Q1 2025, and Part 3 dosing planned for Q3 2025.
Resmetirom and GLP-1 Agonists Show Promise in Treating MASH
Resmetirom, an orally administered liver-targeted thyroid hormone receptor-β selective agonist, has shown promising results in treating MASH, with significant improvements in liver health observed in clinical trials. GLP-1 agonists, primarily used for diabetes and obesity, are also being explored for MASH treatment, offering a complementary approach by targeting extrahepatic mechanisms. Despite their potential, challenges remain, including anti-fibrosis effects and long-term tolerability.
Boehringer Ingelheim Achieves Significant Pipeline Progress in First Half of 2024
Boehringer Ingelheim has reported significant progress in its pharmaceutical pipeline during the first half of 2024, with notable advancements in cardiovascular, renal, metabolic health, and oncology. The company also experienced a 7.4% year-on-year growth in net sales, driven by high demand for its medications. Key developments include positive Phase II data for survodutide in treating metabolic dysfunction-associated steatohepatitis (MASH) and the initiation of a Phase III trial for a novel selective aldosterone synthase inhibitor in chronic heart failure.
Breakthroughs and Trends in Anti-Obesity Drug Development for 2024
The anti-obesity drug landscape is evolving with the introduction of breakthrough treatments like Semaglutide and Tirzepatide, alongside the development of innovative monotherapies, combination therapies, and emerging injectable pharmacotherapies. The focus is also shifting towards oral drug formulations and addressing sarcopenia in obesity treatment. Preclinical research and clinical trials continue to play a crucial role in advancing obesity therapeutics.
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