pemvidutide (ALT-801) / Altimmune - LARVOL DELTA

Incretin-Based Therapies in MASH: A Meta-Analysis of Hepatic and Metabolic Outcomes (ACG 2025) - "Incretin-based therapies significantly reduced liver fat in MASH patients. Triple agonist retatrutide achieved the greatest reduction (up to 83%), followed by dual GLP-1/glucagon agonists (pemvidutide: 64%, survodutide: 60%) and GLP-1/GIP agonist tirzepatide (47%). GLP-1 monotherapy (semaglutide) also reduced liver fat (39%) and improved liver enzymes."

Retrospective data • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Altimmune Announces FDA Fast Track Designation for Pemvidutide in Alcohol Use Disorder (AUD) (GlobeNewswire) - "RECLAIM (NCT06987513), a Phase 2 trial evaluating the safety and efficacy of pemvidutide in AUD, is currently enrolling."

Enrollment status • Fast track • Addiction (Opioid and Alcohol)

Review: Special Issue: Real-world evidence on the use of GLP1 receptor agonists: Emerging concepts in obesity management: focus on glucagon receptor agonist combinations. (PubMed, Drugs Context) - "Agents like mazdutide, pemvidutide, survodutide and retatrutide have demonstrated the ability to trigger significant weight loss in earlier phase trials, often surpassing the amount of weight loss obtained with existing therapies...Key considerations as these drugs move forward in development to eventual approval include cost, access and long-term safety. This article is part of the Real-world evidence on the use of GLP1 receptor agonists Special Issue: https://www.drugsincontext.com/special_issues/real-world-evidence-on-the-use-of-glp1-receptor-agonists."

HEOR • Journal • Real-world evidence • Review • Cardiovascular • Diabetes • Endocrine Disorders • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

New data on corrected T1 (cT1) imaging demonstrates potentially class-leading improvements in pemvidutide-treated patients (GlobeNewswire) - "cT1 is a highly reproducible MRI-based imaging method that measures the magnitude of liver inflammation and fibrosis. Decreases in cT1 relaxation time of 80 milliseconds (ms) or greater have been correlated with improvements in liver inflammation and fibrosis in clinical studies; In an analysis of imaging data from the IMPACT trial, mean decreases from baseline in cT1 relaxation time were 145.0 ms and 147.9 ms in the pemvidutide 1.2 mg and 1.8 mg groups, respectively, compared with a decrease of 27.5 ms in placebo (p < 0.001 for both)....The IMPACT trial is ongoing with data on weight loss, NITs and safety at 48 weeks of treatment expected in the fourth quarter of 2025; End-of-Phase 2 Meeting with FDA targeted for fourth quarter of 2025."

FDA event • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD) (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Altimmune, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

Altimmune Announces Initiation of RESTORE Phase 2 Trial Evaluating the Efficacy and Safety of Pemvidutide in Alcohol-Associated Liver Disease (ALD) (GlobeNewswire) - "Altimmune, Inc...announced that it has enrolled the first patient in the RESTORE Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol-Associated Liver Disease (ALD)...RESTORE (NCT07009860) is a randomized, placebo-controlled trial enrolling approximately 100 patients across 34 sites, with Dr. Rohit Loomba, Professor of Medicine, Chief of the Division of Gastroenterology and Hepatology, and Director of the MASLD Research Center at the University of California, San Diego, serving as the principal investigator. Patients will be randomized 1:1 to 2.4mg pemvidutide or placebo for 48 weeks. The primary endpoint of the trial is the change from baseline in liver stiffness measurement (LSM) by vibration controlled transient elastography (VCTE) at Week 24."

Enrollment open • Hepatology

Altimmune to Announce Topline 24 Week Results from its IMPACT Phase 2b Trial of Pemvidutide in the Treatment of MASH on Thursday, June 26 (GlobeNewswire) - "Altimmune...will host an investor webcast on Thursday, June 26, 2025 at 8:30 am E.T. to present topline 24 week data from its IMPACT Phase 2b trial evaluating pemvidutide in the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH)....A final readout is anticipated in the fourth quarter of 2025."

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Topline Results from the IMPACT Phase 2b Trial of Pemvidutide in the Treatment of MASH (GlobeNewswire) - P2b | N=190 | IMPACT (NCT05989711) | Sponsor: Altimmune, Inc. | "Treatment discontinuation rates were low, with only 9% of participants prematurely discontinuing treatment. In an intent-to-treat (ITT) analysis, in which participants with missing biopsies were considered non-responders, the proportions of participants achieving MASH resolution without worsening of fibrosis at 24 weeks were 59.1% and 52.1% for pemvidutide 1.2 mg and 1.8 mg, respectively versus 19.1% for placebo (p< 0.0001 both doses). The effects on fibrosis improvement without worsening of MASH in an ITT analysis were 31.8% and 34.5% for pemvidutide 1.2 mg and 1.8 mg, respectively compared with 25.9% for placebo (differences not statistically significant)...final readout is anticipated in the fourth quarter of 2025."

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Pemvidutide, a Balanced GLP-1/Glucagon Dual Receptor Agonist, Enhances Reverse Cholesterol Transport in a Golden Syrian Hamster Model (ADA 2025) - "Pemvidutide treatment increased excretion of cholesterol into feces and upregulated transporters of cellular cholesterol in the liver, consistent with increased RCT. These findings suggest that in addition to other mechanisms, pemvidutide improves serum cholesterol through enhanced cholesterol excretion."

Preclinical • Metabolic Disorders • Obesity

Integrated Analysis Supports Cardiovascular Safety and Risk Reduction with Pemvidutide Treatment (ADA 2025) - "Pemvidutide reduces SBP and DBP without clinically meaningful effects on QTc or HR and no imbalances in cardiac adverse events."

Clinical • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Noninvasive Tests of Central Adiposity Correlate with Reductions in MRI-Measured Visceral Adipose Tissue Mass in Subjects with Overweight or Obesity Treated with Pemvidutide (ADA 2025) - "BRI and WHtR may be useful for estimating VAT mass changes resulting from pemvidutide treatment."

Clinical • Non-invasive • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Effects of Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, on Cardioinflammatory Lipids in Subjects with Obesity or Overweight (ADA 2025) - "Pemvidutide elicited significant weight loss and decreases in atherogenic pro-inflammatory lipid species in subjects with obesity or overweight."

Clinical • Diabetes • Metabolic Disorders • Obesity

Altimmune Announces Multiple Presentations at Upcoming American Diabetes Association’s Scientific Sessions (GlobeNewswire) - "Altimmune, Inc....today announced an oral presentation and three poster presentations on pemvidutide at the American Diabetes Association’s (ADA) 85th Scientific Sessions, to be held in Chicago, IL from June 20-23, 2025."

Clinical data • Obesity

IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=190 | Active, not recruiting | Sponsor: Altimmune, Inc. | Trial completion date: Sep 2025 ➔ Dec 2025

Trial completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD) (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Altimmune, Inc.

New P2 trial • Hepatology

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Altimmune, Inc.

New P2 trial • Addiction (Opioid and Alcohol) • Genetic Disorders • Obesity

Altimmune Announces Initiation of RECLAIM Phase 2 Trial Evaluating the Efficacy and Safety of Pemvidutide in Alcohol Use Disorder (AUD) (GlobeNewswire) - "Altimmune, Inc...announced that it has enrolled the first subject in the RECLAIM Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol Use Disorder (AUD)...The trial is expected to enroll approximately 100 subjects randomized 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks. The primary endpoint of the trial is a change in alcohol consumption, assessed as the change from baseline in the average number of heavy drinking days per week at Week 24, with the key secondary endpoints including the proportion of subjects achieving a 2-level reduction in World Health Organization (WHO) risk drinking level and the absolute change from baseline in average levels of phosphatidylethanol (PEth), a serum biomarker of alcohol intake."

Enrollment open • CNS Disorders

Altimmune Secures Up to $100 Million in Credit Facility from Hercules Capital (GlobeNewswire) - "Altimmune...announced that it has entered into an agreement with Hercules Capital..., a leader in debt financing for life science companies, for up to $100 million in a credit facility, with a $15 million tranche funded at closing....Access to this additional capital strengthens Altimmune’s balance sheet, which included $150 million in cash and cash equivalents as of March 31, 2025, and will support the ongoing development of pemvidutide, Altimmune’s novel GLP-1/glucagon dual receptor agonist."

Financing • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Presents New Analyses Predicting High Rates of MASH Resolution on Biopsy following Pemvidutide Treatment at the EASL International Liver Congress (GlobeNewswire) - P=NA | N=NA | "The presentation focuses on the use of the MASH Resolution Index (MASHResInd) algorithm to predict MASH resolution on biopsy in patients treated with pemvidutide, Altimmune’s 1:1 GLP-1/glucagon dual receptor agonist....The composite MASHResInd score is a robust, non-invasive marker for liver histology improvement, with potential application across clinical research and practice. In the analyses presented at EASL, 24 weeks of treatment with pemvidutide resulted in MASHResInd responses (defined as an index ≥ -0.67) in 69.2%, 92.3% and 90.9% of subjects receiving 1.2 mg (p<0.05), 1.8 mg (p<0.001), and 2.4 mg (p<0.001) of pemvidutide, respectively, compared with 22.2% in subjects receiving placebo."

Clinical data • Diagnostic • Non-invasive • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Announces First Quarter 2025 Financial Results and Business Update (GlobeNewswire) - "Top-line data from the IMPACT Phase 2b trial of pemvidutide in biopsy-confirmed F2/F3 MASH expected in Q2 2025: Top-line data is expected to include rates of MASH resolution and fibrosis improvement, weight loss, non-invasive tests, and data on safety and tolerability. A total of 212 participants were randomized, exceeding the 190 originally planned....Investigational New Drug (IND) applications were cleared by the FDA in the first quarter of 2025. The Phase 2 trials in AUD and ALD are expected to initiate in the second and third quarters of 2025, respectively."

IND • New P2 trial • P2b data • Trial status • Alcoholic Fatty Liver Disease • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune to Present at Upcoming EASL International Liver Congress 2025 (GlobeNewswire) - "Altimmune, Inc...announced that the Company will present analyses of pemvidutide-treated subjects with metabolic dysfunction-associated steatotic liver disease (MASLD) utilizing the MASH Resolution Index (MASHResInd; Loomba 2024), a highly sensitive non-invasive measure of MASH histologic response, in a poster session at the European Association for the Study of the Liver (EASL) International Liver Congress 2025 in Amsterdam, The Netherlands. The abstract will be featured in the conference poster session and poster tour."

Clinical • Non-invasive • Metabolic Dysfunction-Associated Steatohepatitis

Change in cT1 following interventions in metabolic dysfunction-associated steatotic liver disease: a systematic review and meta-analysis (EASL 2025) - "By treatment type, fibroblast growth factor (FGF) analogues (aldafermin; pegozafermin), glucagon-like peptide (GLP)-1 receptor agonists (pemvidutide; tirzepatide) and farnesoid X receptor (FXR) agonists (vonafexor; ocaliva; TERN-101), cT1 had a mean change of -79ms [95% CI: -90, - 68], -68ms [95% CI: -77, -58] and -62ms [95% CI: -74, -49], respectively... Evidence to-date supports a significant treatment-induced reduction in cT1 as compared to minimal changes in the placebo group. Our findings could inform current and future study designs for investigational therapies for liver disease and support monitoring of treatment response in individuals with MASLD in clinical trials and clinical practice."

Retrospective data • Review • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • FGF

MASH resolution index, a novel, highly sensitive non-invasive measure of histologic improvement, predicts high rates of MASH resolution with pemvidutide treatment of metabolic dysfunction-associated steatohepatitis (MASH) (EASL 2025) - No abstract available

Non-invasive • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

MASH resolution index, a novel, highly sensitive non-invasive measure of histologic improvement, predicts high rates of MASH resolution with pemvidutide treatment of metabolic dysfunction-associated steatohepatitis (MASH) (EASL 2025) - "Pemvidutide administered for 24 weeks was associated with significantly greater MASHResInd and cT1 responses. These findings suggest a high probability of achieving MASH resolution with pemvidutide in biopsy-driven trials."

Non-invasive • Diabetes • Fibrosis • Genetic Disorders • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Change in cT1 following interventions in MASLD: A systematic review and meta-analysis (APASL 2025) - "By treatment type, fibroblast growth factor (FGF) analogues (aldafermin; pegozafermin), glucagon-like peptide (GLP)-1 receptor agonists (pemvidutide; tirzepatide) and farnesoid X receptor (FXR) agonists (vonafexor; ocaliva; TERN-101), cT1 had a mean change of -79ms [95% CI: -90, -68], -68ms [95% CI: -77, -58] and -62ms [95% CI: -74, -49], respectively... Evidence to-date supports a significant treatment-induced reduction in cT1 as compared to minimal changes in the placebo group. Our findings could inform current and future study designs for investigational therapies for liver disease and support monitoring of treatment response in individuals with MASLD in clinical trials and clinical practice. Table and Figure:Figure 1.Figure."

Retrospective data • Review • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease • FGF