Altimmune Presents New Analyses Predicting High Rates of MASH Resolution on Biopsy following Pemvidutide Treatment at the EASL International Liver Congress™

GAITHERSBURG, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing next-generation peptide-based therapeutics for liver and cardiometabolic diseases, today announced the presentation of new analyses at the European Association for the Study of the Liver (EASL) Congress™ in Amsterdam, The Netherlands. 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.

Developed by Dr. Rohit Loomba, Professor of Medicine, Director of Hepatology, and Vice Chief, Division of Gastroenterology at University of California San Diego, MASHResInd is a composite score incorporating multiple non-invasive tests, including MRI proton-density-fat-fraction (MRI-PDFF), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels for predicting MASH resolution on biopsy. Applied to datasets from a previously completed trial with pemvidutide in subjects with metabolic dysfunction-associated steatotic liver disease (MASLD), the MASHResInd predicted a high probability that MASH resolution would occur with pemvidutide treatment.

“These findings underscore the potential of pemvidutide to achieve meaningful histologic improvements in MASH using non-invasive, reproducible biomarkers,” said Dr. Loomba. “We are encouraged by the significant response in the MASHResInd model, which may suggest a high likelihood of achieving MASH resolution in Altimmune’s IMPACT Phase 2b Trial of pemvidutide.”

Key Data Highlights:

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.

“This analysis of patients from our study of pemvidutide in MASLD further reinforces our excitement around the upcoming IMPACT readout, which remains on track to be reported this quarter,” added Scott Harris, M.D., Chief Medical Officer of Altimmune. “Our MASLD trial achieved class-leading reductions in liver fat content, which is recognized to be a primary driver for MASH resolution and fibrosis improvement. The MASHResInd response rates greater than 90% at the 1.8 and 2.4 mg pemvidutide doses give us further confidence in the ability of pemvidutide to achieve statistical significance in the 24-week biopsy-based endpoints of the IMPACT Trial.”

Presentation Details

The posters presented at the EASL International Liver Congress™ 2025 will be accessible on the Events section of the Altimmune website.

Pemvidutide is a novel, investigational, peptide-based 1:1 GLP-1/glucagon dual receptor agonist in development for the treatment of obesity, MASH, alcohol use disorder (AUD) as well as alcohol liver disease (ALD). Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss with class-leading lean mass preservation, and robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial. IND applications in AUD and ALD have received FDA clearance with Phase 2 trials to commence in mid-2025.

Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity, MASH, alcohol use disorder as well as alcohol related liver disease. For more information, please visit www.altimmune.com.

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