Significant reductions across non-invasive measures of liver fat, inflammation and fibrosis observed at 48 weeks of pemvidutide treatment, with generally favorable tolerability profile
Publication of results provides further validation for the balanced 1:1 glucagon/GLP-1 dual receptor agonist profile of pemvidutide
MORRISTOWN, N.J., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a biopharmaceutical company advancing pemvidutide, an investigational balanced 1:1 glucagon/GLP-1 dual receptor agonist, in serious liver diseases, today announced the publication of 48-week results from the IMPACT Phase 2b trial of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH) in The Lancet Gastroenterology & Hepatology. The paper, titled “Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 48-week results from a multicentre, randomised, double-blind, phase 2b study,” reports secondary endpoints of MASH resolution and fibrosis improvement following 48 weeks of treatment.
The publication in The Lancet Gastroenterology & Hepatology builds upon the previously published 24-week results from IMPACT, in which pemvidutide met the primary endpoint of MASH resolution without worsening of fibrosis. (Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study) At Week 48, pemvidutide treatment resulted in significant reductions versus placebo across multiple non-invasive measures of liver fat, hepatic inflammation and fibrosis, together with significant weight loss. The results suggest continued improvement in liver health.
“Building on the findings presented at The Liver Meeting®, the published IMPACT results show that improvements seen earlier in treatment increased across multiple measures of liver health, including inflammation and, importantly, fibrosis,” said Mazen Noureddin, M.D., IMPACT trial principal investigator, Professor of Medicine at Houston Methodist Hospital and Co-Chair of the Board of Summit Clinical Research Solutions. “These findings are particularly encouraging given the role of fibrosis in long-term outcomes in MASH. Liver benefits were accompanied by weight loss and maintenance of glycemic control, with generally favorable gastrointestinal tolerability and no significant change in heart rate. Taken together, these results provide a strong foundation for the ongoing PERFORMA Phase 3 trial and give us real confidence in pemvidutide’s potential to become one of the next approved treatments for MASH.”
Weight loss with the 1.8 mg dose appeared to continue through the end of the 48-week treatment period, and no significant changes in heart rate were observed with treatment while glycemic control was maintained. Pemvidutide demonstrated a generally favorable tolerability profile over 48 weeks despite being administered without dose titration. Approximately 1% of total patients receiving pemvidutide discontinued treatment due to adverse events (AEs). The majority of AEs were mild to moderate, and no imbalances in cardiac AEs were observed with pemvidutide versus placebo. Most gastrointestinal AEs were mild to moderate in severity and predominantly occurred within the first 8 weeks.
“What is especially compelling about these 48-week results is the breadth of benefit we continue to see across the key drivers of MASH, from significant reductions in liver fat to continued improvements in measures of inflammation and fibrosis,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune. “Combined with meaningful weight loss and generally favorable tolerability, these data reinforce our belief that pemvidutide has the potential to offer a differentiated approach to treating MASH, and further derisk our Phase 3 PERFORMA trial. We look forward to continuing its execution to potentially deliver valuable treatment options to patients as rapidly as possible.”
About the IMPACT Phase 2b Study
The randomized, placebo-controlled, double-blind IMPACT Phase 2b trial (NCT05989711) enrolled 212 participants with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomized 1:2:2 to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks. The primary efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss measured at 24 and 48 weeks.
About Pemvidutide
Pemvidutide is a novel investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity that has an effect on reducing liver fat, inflammation, and fibrosis, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss and are involved in pathways related to craving and reward.
The FDA has granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced topline 48-week data from the IMPACT Phase 2b trial in MASH. In July 2026, the PERFORMA Phase 3 trial, a global, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH was initiated. In July 2026, the Company announced positive topline results from the RECLAIM Phase 2 trial in AUD. In August 2026, the Company announced completion of enrollment of the RESTORE Phase 2 trial in ALD.
About Altimmune
Altimmune is a biopharmaceutical company developing pemvidutide for patients with serious liver diseases. Pemvidutide, a unique dual-action investigational therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio, is in late-stage clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), recently showed robust results in the RECLAIM Phase 2 trial in alcohol use disorder (AUD) and is being studied in alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com.
Forward-Looking Statements
Any statements made in this press release related to the Company’s planning, development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the ongoing PERFORMA and RESTORE trials, and completed RECLAIM trial, the timing of key milestones for the Company’s clinical programs, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov.
Investor Contact:
Luis Sanay, CFA
ir@altimmune.com
Media Contact:
Marisa Sharkey
media@altimmune.com
