pemvidutide (ALT-801) / Altimmune - LARVOL DELTA

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

Altimmune to test obesity drug for alcohol use disorder and related health conditions (Reuters) - "Altimmune...said on Thursday that it plans to test its lead experimental obesity drug, pemvidutide, to potentially treat alcohol use disorder and alcohol-associated liver disease....Altimmune plans to initiate a mid-stage trial testing pemvidutide for alcohol use disorder in the second quarter and another mid-stage trial testing it for alcohol-associated liver disease in the third quarter of this year."

New trial • Hepatology

Multifunctional incretin peptides in therapies for type 2 diabetes, obesity and associated co-morbidities. (PubMed, Peptides) - "Recent studies with peptide-based incretin herapies have focussed mainly on the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide and the dual agonist tirzepatide that engages receptors for GLP-1 and glucose-dependent insulinotropic polypeptide (GIP)...New incretin-based peptide therapies in development include a long-acting glucagon receptor agonist (LY3324954), dual GLP-1/glucagon receptor agonists (survodutide, pemvidutide, mazdutide, G49), triple GLP-1/GIP/glucagon receptor agonists (retatrutide, efocipegtrutide), a combination of semaglutide with the amylin analogue cagrilintide (CagriSema), a unimolecular GLP-1/amylin receptor dual agonist (amycretin), and a GIP receptor antibody with GLP-1 receptor agonism (MariTide). The creation of multi-targeting incretin-based synthetic peptides provides opportunities for improved management of type 2 diabetes and obesity as well as new therapeutic approaches to an expanding list of associated co-morbidities. The..."

Journal • Cardiovascular • Diabetes • Genetic Disorders • Hepatology • Inflammation • Metabolic Disorders • Nephrology • Obesity • Obstructive Sleep Apnea • Orthopedics • Renal Disease • Respiratory Diseases • Sleep Apnea • Sleep Disorder • Type 2 Diabetes Mellitus

Current priorities in research on metabolic-associated fatty liver disease based on the results of EASL - 2024. (PubMed, Pol Merkur Lekarski) - " Studies on the pathogenesis of MASLD progression confirm the significant role of insulin resistance and hyperinsulinemia in increasing hepatocyte cytolysis activity, raising the concentration of cytokeratin CK-18, HbA1c, low-density lipoproteins, triglycerides, and the severity of fibrosis (FIB-4). EASL 2024 studies evaluated the diagnostic efficiency of non-invasive methods for assessing steatosis and liver fibrosis severity in MASLD (FIB-4, FibroScan®, Enhanced Liver Fibrosis (ELF), Vibration Controlled Transient Elastography (VCTE), LiverPRO, etc.). Due to the high prevalence of steatotic liver disease, comorbidities such as chronic viral hepatitis C, autoimmune hepatitis, and alcoholic liver disease - contributing to liver fibrosis progression and hepatocellular carcinoma - are significant. Promising drugs for MASLD treatment include resmethyrom, fibroblast growth factor 21 analogs (including pegosafermin), and pemvidutide, a long-acting, balanced..."

Journal • Review • Autoimmune Hepatitis • Dyslipidemia • Fibrosis • Gastroenterology • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Oncology • Solid Tumor • FGF21 • KRT18

Altimmune Announces Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update (GlobeNewswire) - "IMPACT, the Company's biopsy-driven Phase 2b trial of pemvidutide in MASH, is on track for top-line data readout in Q2 2025....Additional Indications for Pemvidutide: The Company submitted IND applications for pemvidutide in two additional indications at the end of 2024, both of which have been cleared by FDA. Phase 2 trials in additional indications are expected to initiate in mid-2025....Research and development expenses were $19.8 million for the three months ended December 31, 2024, compared to $16.9 million in the same period in 2023. The expenses for the quarter ended December 31, 2024, included $13.6 million in direct costs related to development activities for pemvidutide."

Commercial • New P2 trial • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Approved and Emerging Hormone-Based Anti-Obesity Medications: A Review Article. (PubMed, Indian J Endocrinol Metab) - "Two GLP1RAs, namely Liraglutide and Semaglutide, have been approved by the Food and Drug Administration (FDA) and European Medicine Agency (EMA) for use in clinical practice for weight loss. Three oral GLP1RAs, namely Semaglutide, Danuglipron, and Orforglipron, are undergoing advanced clinical trials in individuals with obesity. Amylin receptor agonist (AMYRA) Cagrilintide, when used alone or in combination with Semaglutide, has demonstrated substantial weight reduction in clinical trials. Tirzepatide, a dual agonist for the glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptors, has been observed to be associated with a significant placebo-subtracted weight reduction of 17.8% in a 72-week randomized controlled trial...Three long-acting GLP1R/glucagon receptor (GCGR) dual agonists, namely Survodutide, Mazdutide, and Pemvidutide, exhibited significant weight loss in clinical trials. Retatrutide, a GLP1R/GCGR/GIPR tri-agonist, has been associated with a..."

Journal • Review • Cardiovascular • Genetic Disorders • Obesity

Altimmune Presents New Data on the Effect of Pemvidutide on Inflammatory Lipids in Subjects with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) at The Liver Meeting 2024 (GlobeNewswire) - P1 | N=95 | NCT05006885 | Sponsor: Altimmune, Inc. | "Altimmune, Inc...today presented new data from its 12-week Phase 1b trial of pemvidutide in metabolic dysfunction-associated steatotic liver disease (MASLD) at The Liver Meeting of the American Association for the Study of Liver Diseases....The new data were derived from an analysis of plasma samples from subjects who completed a randomized placebo-controlled Phase 1b trial of pemvidutide in subjects with overweight or obesity and MASLD. In the Phase 1b clinical trial, 94 subjects with obesity or overweight and liver fat content (LFC) ≥10% were dosed 1:1:1:1 to pemvidutide (1.2mg, 1.8mg and 2.4mg) or placebo administered once-weekly subcutaneously for 12 weeks. In this study, pemvidutide reduced LFC relative to baseline by up to 68.5% and decreased total cholesterol and triglycerides by up to 12.2% and 44.6%, respectively, after 12 weeks of treatment."

P1 data • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis