pemvidutide (ALT-801) / Altimmune - LARVOL DELTA

Efficacy and safety of pemvidutide in metabolic dysfunction-associated steatohepatitis: a GRADE-assessed meta-analysis of randomized controlled trials. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Pemvidutide significantly improves hepatic and metabolic parameters in MASLD/MASH with acceptable tolerability. Larger, longer trials are warranted to confirm antifibrotic efficacy."

Journal • Retrospective data • Cardiovascular • Heart Failure • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Concurrent responses in multiple non-invasive tests for hepatic inflammation and fibrosis following pemvidutide treatment: 24-week responder analyses of the phase 2b IMPACT trial in metabolic dysfunction-associated steatohepatitis (EASL 2026) - No abstract available

Non-invasive • P2b data • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Effect of pemvidutide on cardiovascular risk factors in patients with metabolic dysfunction-associated steatohepatitis: 48-week results from the phase 2b, IMPACT trial (EASL 2026) - No abstract available

Clinical • P2b data • Cardiovascular • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Week 48 top-line results from the phase 2b, multicenter, randomized, placebo-controlled IMPACT trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (EASL 2026) - No abstract available

Clinical • P2b data • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Announces Fourth Quarter and Full-year 2025 Financial Results and Business Updates (The Manila Times) - "Initiation of Phase 3 MASH trial planned for 2026....Successful End-of-Phase 2 Meeting with FDA: Alignment on Phase 3 registrational trial design confirmed following receipt of meeting minutes; Global Phase 3 trial expected to evaluate multiple pemvidutide doses over a 52-week treatment period with biopsy-based endpoints to support potential accelerated approval; Company has submitted request for scientific advice to European regulators."

New P3 trial • Metabolic Dysfunction-Associated Steatohepatitis

Glucagon-like peptide 1 receptor agonists in substance use disorders: A systematic review of ClinicalTrials.Gov. (PubMed, Addict Behav Rep) - "Agents studied included semaglutide (n = 15), exenatide (n = 8), tirzepatide (n = 6), liraglutide (n = 2), dulaglutide (n = 1), and pemvidutide (n = 1)...While GLP-1RAs may represent a paradigm shift for treating SUD, current trials have focused on alcohol and nicotine/tobacco use disorders, with notable gaps for methamphetamine and cannabis use disorders. Trials testing next-generation GLP-1RAs with FDA recommended endpoints are needed to define efficacy and safety across SUDs."

Journal • Addiction (Opioid and Alcohol) • Nicotine Addiction • Substance Abuse • Tobacco Addiction

Systemic Pharmacokinetic Principles of Therapeutic Peptides. (PubMed, Clin Pharmacokinet) - "In summary, our results underscore that the systemic pharmacokinetics of peptide drugs generally follow size-related physiological scaling patterns and provide quantitative tools to facilitate translational assessments in the drug discovery process."

Journal • PK/PD data

Altimmune Announces Pricing of $75 Million Registered Direct Offering of Common Stock (GlobeNewswire) - "Altimmune intends to use the net proceeds to fund preparation for its upcoming Phase 3 trial in metabolic dysfunction-associated steatohepatitis (MASH) as well as for working capital and general corporate purposes."

Financing • New P3 trial • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Receives FDA Breakthrough Therapy Designation for Pemvidutide in MASH (Yahoo Finance) - "Breakthrough Therapy Designation for pemvidutide in MASH was granted based on submission of 24-week data from the IMPACT Phase 2b trial demonstrating statistically significant MASH resolution without worsening of fibrosis, along with early and substantial improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation....The Company plans to initiate a Phase 3 trial evaluating multiple pemvidutide doses over a 52-week treatment period."

Breakthrough therapy • New P3 trial • Metabolic Dysfunction-Associated Steatohepatitis

IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=212 | Completed | Sponsor: Altimmune, Inc. | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Announces that Pemvidutide Achieved Key Measures of Success at 48 Weeks in IMPACT Phase 2b MASH Trial (GlobeNewswire) - "Pemvidutide-treated participants achieved statistically significant reductions in primary non-invasive markers of fibrosis, including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM). ELF: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of -0.49 and -0.58 respectively, vs. +0.16 in placebo-treated patients (p<0.0001, both doses). LSM: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of -3.04 (p<0.05) and -3.97 (p<0.001), respectively, vs. -0.03 in placebo-treated participants."

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

End-of-Phase 2 meeting with FDA supports advancing to registrational Phase 3 trial in MASH patients with moderate to advanced liver fibrosis (GlobeNewswire) - "Additionally, the Company announced that it held a productive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) which resulted in alignment on the parameters for a registrational Phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis. With the FDA’s recent qualification of AIM-MASH AI Assist, the Agency was open to the Company’s intent to integrate use of this AI tool into the Phase 3 trial."

FDA event • Metabolic Dysfunction-Associated Steatohepatitis

Muscle Loss in Obesity Therapy as a Therapeutic Target: Trial Design and Endpoints for Regulatory Discussions. (PubMed, J Cachexia Sarcopenia Muscle) - "Discussions highlighted the impact of glucagon-like peptide-1 (GLP-1) receptor agonists or GLP-1/glucose-dependent insulinotropic polypeptide (i.e., GLP-1/GIP) agonists on body composition and muscle health; the challenges of distinguishing 'true' skeletal muscle from fat-free tissue; the impact of treatment discontinuation and weight regain; advances in imaging and quantitative assessment of lean body mass; as well as insights from emerging muscle-preserving therapies (e.g., bimagrumab, pemvidutide and enobosarm)...These also involve significant regulatory considerations for future drug development and approval pathways, for instance related to the very large number of individuals that may be considered for these therapeutic approaches as well as from the potential long (or life-long) duration of therapy considered with these drugs. Together, these discussions highlight the growing importance of integrating body composition and functional assessments in future..."

Journal • Cachexia • Genetic Disorders • Obesity • Sarcopenia

The dual GLP-1-glucagon agonist pemvidutide in MASH: a phase 2b trial. (PubMed, Lancet) - No abstract available

Journal • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

RECLAIM STUDY: A Phase 2 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 | Active, not recruiting | Sponsor: Altimmune, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2026 ➔ Jun 2026 | Trial primary completion date: Sep 2026 ➔ May 2026

Enrollment closed • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • Genetic Disorders • Obesity

Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study. (PubMed, Lancet) - P2 | "Pemvidutide treatment met the primary endpoint of MASH resolution without worsening of fibrosis at 24 weeks but did not meet the other primary endpoint of fibrosis improvement without worsening of MASH at this timepoint. Additional trials of longer duration are planned."

Journal • P2b data • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

DA-1726, An Oxyntomodulin Analogue: A Promising Therapy for Obesity and Related Metabolic Disorders (OBESITY WEEK 2025) - "In conclusion, these findings suggest that DA-1726 offers advantages including superior weight loss, increased EE, and improved lipid metabolism. These results support the potential of DA-1726 as a promising therapeutic option for the treatment of obesity and associated metabolic disorders."

Dyslipidemia • Genetic Disorders • Metabolic Disorders • Obesity

Recent Highlights and Anticipated Milestones: Metabolic Dysfunction-Associated Steatohepatitis (MASH) (GlobeNewswire) - "End-of-Phase 2 Meeting with FDA scheduled for fourth quarter 2025: During the in-person meeting, the Company is seeking alignment with the Agency on its proposed Phase 3 trial design and study endpoints; 48-week data from Phase 2b IMPACT Trial to be reported in fourth quarter 2025: The readout will include longer-term NIT and weight loss data."

FDA event • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Presents AI-Based Analysis of Liver Fibrosis Reduction from IMPACT Phase 2b Trial of Pemvidutide in MASH in Late-breaking Poster at AASLD The Liver Meeting 2025 (GlobeNewswire) - "Data for total fibrosis showed 31% of patients in the pemvidutide 1.8 mg group (n=85), and 12% of patients in the pemvidutide 1.2 mg group (n=41) achieved a ≥ 60% reduction in the area of fibrosis compared to 8% of placebo-treated patients (n=86, p= 0.0003 and p=0.5, respectively); Data for early fibrosis showed 34% of patients in the pemvidutide 1.8 mg group (n=85), and 24% of patients in the pemvidutide 1.2 mg group (n=41) achieved ≥ 60% reduction in the area of fibrosis compared to 9% of placebo-treated patients...Data for advanced fibrosis showed 27% of patients in the pemvidutide 1.8 mg group (n=85), and 5% of patients in the pemvidutide 1.2 mg group (n=41) achieved ≥ 60% reduction in the area of fibrosis..."

Late-breaking abstract • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

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 to Present Phase 2b IMPACT Data on Pemvidutide in MASH in Late-Breaking Oral Podium Presentation and Late-Breaking Poster at AASLD The Liver Meeting 2025 (GlobeNewswire) - "Oral presentation to highlight 24-week efficacy and safety data. Poster to feature results of AI-based analyses of liver fibrosis reduction."

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial. (PubMed, JHEP Rep) - P1 | "The current trial demonstrates that continued treatment with pemvidutide further improves these clinical markers of MASH. The study is registered at ClinicalTrials.gov (NCT05292911)."

Clinical • Journal • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus

Altimmune Appoints Industry Veteran Christophe Arbet-Engels, M.D., PhD as Chief Medical Officer to Drive Next Phase of Clinical Development of Pemvidutide. (GlobeNewswire) - Dr Arbet-Engels...will lead the ongoing clinical development of pemvidutide including the planned Phase 3 trial in metabolic dysfunction-associated steatohepatitis (MASH).

New P3 trial • Metabolic Dysfunction-Associated Steatohepatitis

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