"Of the 28 million Americans with AUD, over 6 million have progressed to ALD, a condition for which there are no approved treatments and few in development," said Dr. Loomba. "Alcohol-related liver mortality is highest in patients with comorbid obesity, highlighting the urgent need for a liver-directed therapy that can also drive weight loss. The robust reductions in body weight, liver fat and VCTE and the low rates of adverse event discontinuation in the recently completed IMPACT Phase 2b MASH trial suppor ...

Core Viewpoint - Altimmune, Inc. is set to present topline data from its IMPACT Phase 2b trial evaluating pemvidutide for treating metabolic dysfunction-associated steatohepatitis (MASH) on June 26, 2025 [1][2]. Group 1: Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases [5]. - The company's lead program, pemvidutide, is a GLP-1/glucagon dual receptor agonist aimed at treating MASH, obesity, Alcohol Use Disorder (AUD), and Alcohol-associated Liver Disease (ALD) [5]. Group 2: IMPACT Study Details - The IMPACT trial enrolled 212 patients with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive either weekly subcutaneous pemvidutide at doses of 1.2 mg and 1.8 mg or placebo for 24 weeks [3]. - Key efficacy endpoints include MASH resolution or fibrosis improvement at 24 weeks, with secondary endpoints focusing on weight loss and non-invasive tests [3]. - A total of 48 weeks of treatment is planned, with final readout expected in Q4 2025 [3]. Group 3: Pemvidutide Characteristics - Pemvidutide is an investigational peptide-based dual receptor agonist that mimics the effects of diet and exercise on weight loss, suppressing appetite and increasing energy expenditure [4]. - Clinical trials have shown significant MASH resolution, liver fibrosis improvement, and weight loss, along with reductions in liver fat content, triglycerides, LDL cholesterol, and blood pressure [4]. - The U.S. FDA has granted Fast Track designation to pemvidutide for MASH treatment, with ongoing trials for AUD and ALD [4].

Core Insights - Altimmune, Inc. is presenting findings on pemvidutide, a novel GLP-1/glucagon dual receptor agonist, at the American Diabetes Association's 85 Scientific Sessions, focusing on its potential in treating metabolic dysfunction-associated steatohepatitis (MASH), obesity, alcohol use disorder (AUD), and alcohol-associated liver disease (ALD) [1][4]. Group 1: Presentation Details - The oral presentation titled "Effects of Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, on Cardioinflammatory Lipids in Subjects with Obesity or Overweight" will be held on June 21, 2025, at 5:45 PM CDT [2]. - Three poster presentations will cover topics including cardiovascular safety, non-invasive tests of central adiposity, and cholesterol transport in a hamster model, all scheduled for June 22, 2025 [2]. Group 2: Pemvidutide Overview - Pemvidutide is designed to activate GLP-1 and glucagon receptors, mimicking the effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure [3]. - Clinical trials have shown that pemvidutide leads to significant weight loss, preservation of lean mass, and reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure [4]. Group 3: Regulatory Status and Trials - The U.S. FDA has granted Fast Track designation to pemvidutide for MASH treatment, with the MOMENTUM Phase 2 obesity trial completed in 2024 and ongoing IMPACT Phase 2b MASH trial expected to report top line results in Q2 2025 [4]. - IND applications for AUD and ALD have received FDA clearance, with the Phase 2 trial for AUD starting in Q2 2025 and the ALD trial set to begin in Q3 2025 [4]. Group 4: Company Background - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases, with pemvidutide as its lead program [5].

Core Insights - Altimmune, Inc. has initiated the RECLAIM Phase 2 trial for pemvidutide, targeting Alcohol Use Disorder (AUD) [1][2] - Pemvidutide is a dual receptor agonist aimed at treating metabolic dysfunction-associated steatohepatitis (MASH), obesity, AUD, and alcohol liver disease (ALD) [1][4] - The trial will enroll approximately 100 subjects and assess changes in alcohol consumption and related biomarkers [2][3] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on peptide-based therapeutics for liver and cardiometabolic diseases [4] - The lead program, pemvidutide, is designed to address multiple conditions including MASH, obesity, AUD, and ALD [4] Industry Context - Over 28 million individuals in the U.S. are affected by AUD, with less than 10% currently receiving treatment [3] - Existing medications for AUD have limited effects and compliance rates, highlighting the need for new therapies [3] - Pemvidutide has shown promising preclinical results, significantly reducing alcohol preference in animal models [3]

MASH Resolution Index (MASHResInd) model highly predictive of MASH resolutionGAITHERSBURG, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing next-generation peptide-based therapeutics for liver and cardiometabolic diseases, today announced the presentation of new analyses at the European Association for the Study of the Liver (EASL) Congress™ in Amsterdam, The Netherlands. The presentation focuses on the use of the MASH Resolution ...

Core Insights - Altimmune, Inc. is presenting analyses of pemvidutide-treated subjects with metabolic dysfunction-associated steatotic liver disease (MASLD) at the EASL International Liver Congress™ 2025, highlighting the use of the MASH Resolution Index as a non-invasive measure of histologic response [1][2] Group 1: Pemvidutide Overview - Pemvidutide is a novel peptide-based dual receptor agonist targeting GLP-1 and glucagon, aimed at treating obesity, MASH, Alcohol Use Disorder (AUD), and Alcohol Liver Disease (ALD) [3] - The drug has shown significant weight loss, lean mass preservation, and reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure in clinical trials [3] - Pemvidutide has received Fast Track designation from the U.S. FDA for MASH treatment and is currently undergoing Phase 2 trials for obesity and MASH [3] Group 2: Company Background - Altimmune is a late clinical-stage biopharmaceutical company focused on developing next-generation peptide-based therapeutics [4] - The company is actively working on pemvidutide for various metabolic and liver-related conditions [4]

OPKO Health (OPK) Q1 2025 Earnings Call April 30, 2025 04:30 PM ET Speaker0 Good afternoon and welcome to the UpcoHealth First Quarter twenty twenty five Financial Results Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead. Speaker1 Thank you, operator. Good afternoon. This is Yvonne Briggs with Allianc ...