pemvidutide (ALT-801) / Altimmune - LARVOL DELTA

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 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 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 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

Pemvidutide, a Balanced GLP-1/Glucagon Dual Receptor Agonist, Enhances Reverse Cholesterol Transport in a Golden Syrian Hamster Model (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Preclinical • Metabolic Disorders

Integrated Analysis Supports Cardiovascular Safety and Risk Reduction with Pemvidutide Treatment (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • Metabolic Disorders

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) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • Non-invasive • Metabolic Disorders • Obesity

Effects of Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, on Cardioinflammatory Lipids in Subjects with Obesity or Overweight (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • Metabolic Disorders • 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

Altimmune to Present New Data on the Lipidomic Profile in Subjects Treated with Pemvidutide at The Liver Meeting 2024 (Yahoo Finance) - "Altimmune, Inc...today announced that new data showing reductions of multiple classes of atherogenic and cardio-inflammatory lipids in subjects treated with pemvidutide will be presented in a poster session at The Liver Meeting® 2024 of the American Association for the Study of Liver Diseases (AASLD) in San Diego, CA taking place November 15-19, 2024. The data were derived from Altimmune’s 12-week Phase 1b randomized, placebo-controlled study in subjects with metabolic dysfunction-associated steatotic liver disease (MASLD), a precursor to the more serious metabolic dysfunction-associated steatohepatitis (MASH). The Company has completed enrollment in a Phase 2b efficacy trial of pemvidutide in patients with biopsy-confirmed F2/F3 MASH, with topline data expected in the second quarter of 2025."

P1 data • P2b data • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

EFFECT OF PEMVIDUTIDE, A GLP-1/GLUCAGON DUAL RECEPTOR AGONIST, ON PLASMA LIPIDOMIC PROFILES IN SUBJECTS WITH METABOLIC DYSFUNCTION-ASSOCIATED STEATOTIC LIVER DISEASE (MASLD) (AASLD 2024) - "Pemvidutide administered weekly for 12 weeks induced significant decreases in MASH associated lipid species. These findings support pemvidutide's potential benefit on MASH and MASH-associated co-morbidities, including atherosclerosis and metabolic syndrome."

Clinical • Atherosclerosis • Cardiovascular • Dyslipidemia • Genetic Disorders • Hepatology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

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

Enrollment closed • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Completes Enrollment in Phase 2b IMPACT Trial of Pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH) (GlobeNewswire) - "Altimmune, Inc...today announced completion of patient enrollment in IMPACT, its Phase 2b biopsy-driven trial evaluating pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) and provided an update on additional development and regulatory initiatives related to pemvidutide....Altimmune also expects to file IND applications for pemvidutide in up to three additional indications with the first of these IND submissions in Q4 2024. The company plans to disclose details on these indications following alignment with the FDA. Preparations for the first trial are underway, with initiation planned for H1 2025."

Enrollment closed • IND • New P1 trial • Pipeline update • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Pemvidutide preserves lean body mass during weight loss in patients with overweight and obesity: results of a phase 2, MRI-based body composition sub-study (EASD 2024) - P2 | "Pemvidutide treatment over 48 weeks resulted in a lean loss index comparable to that reported historically with diet and exercise. The relative preservation of LT together with the preferential loss of VAT over SAT is expected to augment the lipid-lowering effects of pemvidutide in potentially reducing risk of cardiovascular events."

Clinical • P2 data • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Pemvidutide: Top-line data from P2b IMPACT trial (NCT05989711) for MASH in Q1 2025 (Altimmune) - Corporate Presentation

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Announces Publication of Clinical Study of Pemvidutide in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in Journal of Hepatology (Yahoo Finance) - P1 | N=94 | NCT05006885 | Sponsor: Altimmune, Inc | "Altimmune, Inc...today announced the data from its 12-week clinical trial of pemvidutide, an investigational GLP-1/glucagon dual receptor agonist, in metabolic dysfunction-associated steatotic liver disease (MASLD) has been published in the Journal of Hepatology....Relative reductions in LFC from baseline, the study’s primary efficacy endpoint, were up to 68.5% in subjects receiving pemvidutide compared to 4.4% in subjects receiving placebo. Responder analyses showed that up to 94.4% of subjects receiving pemvidutide achieved ≥30% relative reduction in LFC, an important predictor of MASH resolution and fibrosis improvement, compared to only 4.2% receiving placebo (p <0.0001 vs. placebo, respectively)."

P1 data • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease