Core Insights - Altimmune, Inc. has initiated the RESTORE Phase 2 trial for pemvidutide, targeting Alcohol-Associated Liver Disease (ALD) [1][2] - Pemvidutide is a dual receptor agonist aimed at treating various liver and cardiometabolic diseases, including Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Alcohol Use Disorder (AUD) [1][4] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases [5] - The lead program, pemvidutide, is designed to address MASH, AUD, ALD, and obesity [5] Clinical Trial Details - The RESTORE trial will enroll approximately 100 patients across 34 sites, with a 1:1 randomization to receive either 2.4mg pemvidutide or placebo for 48 weeks [2] - The primary endpoint is the change in liver stiffness measurement (LSM) at Week 24, with key secondary endpoints including changes in LSM at Week 48 and alcohol consumption [2] Pemvidutide Efficacy - Previous trials, including the IMPACT Phase 2b trial, demonstrated significant reductions in liver fat, body weight, and liver stiffness, supporting the potential efficacy of pemvidutide [3][4] - Pemvidutide has shown class-leading tolerability with low rates of discontinuation due to adverse events [4] Market Need - There are currently no approved treatments for ALD, and over 6 million Americans with Alcohol Use Disorder have progressed to this condition, highlighting the urgent need for effective therapies [3]

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]

Core Insights - Altimmune, Inc. presented new analyses at the EASL Congress™ highlighting the predictive capability of the MASH Resolution Index (MASHResInd) for MASH resolution in patients treated with pemvidutide, a dual receptor agonist [1][2] Group 1: MASH Resolution Index (MASHResInd) - MASHResInd is a composite score that integrates multiple non-invasive tests, including MRI-PDFF, ALT, and AST levels, to predict MASH resolution on biopsy [2] - In a trial involving pemvidutide for MASLD, MASHResInd indicated a high probability of MASH resolution with treatment [2] Group 2: Pemvidutide Treatment Results - After 24 weeks of treatment, MASHResInd responses were observed in 69.2%, 92.3%, and 90.9% of subjects receiving 1.2 mg, 1.8 mg, and 2.4 mg of pemvidutide, respectively, compared to 22.2% in the placebo group [3][4] - The results suggest that pemvidutide may lead to significant histologic improvements in MASH, with high response rates at the higher doses [3][4] Group 3: Future Developments - The upcoming IMPACT Phase 2b Trial readout is anticipated to be reported this quarter, with confidence in achieving statistical significance based on the trial's results [4] - Pemvidutide has received Fast Track designation from the U.S. FDA for the treatment of MASH and is also being studied for obesity, alcohol use disorder, and alcohol-related liver disease [8][9]

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]