Altimmune Presents New Analyses Predicting High Rates of MASH Resolution on Biopsy following Pemvidutide Treatment at the EASL International Liver Congress™
- High MASHResInd response rates of over 90% at 1.8mg and 2.4mg doses
- Statistically significant results vs placebo (p<0.001 for higher doses)
- IMPACT trial readout expected this quarter
- Class-leading reductions in liver fat content achieved
- None.
Insights
Pemvidutide shows impressive 90%+ MASH resolution prediction rates at higher doses, strongly suggesting efficacy ahead of critical IMPACT trial results.
The MASHResInd model developed by respected hepatologist Dr. Loomba combines multiple non-invasive markers (MRI-PDFF, ALT, AST) to predict MASH resolution without biopsy. When applied to pemvidutide's previous MASLD trial data, the results are remarkably strong, with predicted MASH resolution rates of
This dose-dependent response pattern (
While these are predictive biomarkers rather than actual biopsy results, the strength of these findings increases confidence in pemvidutide's mechanism of action. The upcoming IMPACT trial readout this quarter will provide the definitive biopsy-confirmed data needed to validate these predictions and determine pemvidutide's true clinical potential in MASH treatment.
Pemvidutide's 90%+ predicted MASH resolution rates strengthen investment case ahead of imminent IMPACT trial readout this quarter.
This data presentation at EASL strategically builds momentum for Altimmune's most important near-term catalyst - the Phase 2b IMPACT trial readout confirmed for this quarter. The impressively high predicted MASH resolution rates using the MASHResInd model (
Pemvidutide's dual GLP-1/glucagon mechanism potentially differentiates it in the increasingly competitive NASH/MASH space, where the glucagon component may provide additional hepatic benefits beyond those seen with pure GLP-1 agonists. This is particularly relevant as the MASH therapeutic market represents a multi-billion dollar opportunity with limited approved treatment options.
While these are predictive results rather than actual biopsy-confirmed data, they substantially increase confidence in a positive IMPACT trial outcome. A successful readout would position Altimmune to advance to pivotal Phase 3 studies and potentially seek accelerated regulatory pathways given the significant unmet need in MASH treatment.
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
“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
Presentation Details
Title: 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) Presenter: Shaheen Tomah, M.D., Director, Clinical Development, Altimmune |
Poster Tour Presentation:
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General Poster Session Presentation:
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The posters presented at the EASL International Liver Congress™ 2025 will be accessible on the Events section of the Altimmune website.
About Pemvidutide
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.
About Altimmune
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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ir@altimmune.com
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FAQ
What were the MASHResInd response rates for ALT's pemvidutide treatment?
What is the MASH Resolution Index (MASHResInd) used in Altimmune's study?
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What is pemvidutide and how does it work?
