In This Article:
MASH Resolution Index (MASHResInd) model highly predictive of MASH resolution
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.”