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Altimmune Announces that Pemvidutide Achieved Key Measures of Success at 48 Weeks in IMPACT Phase 2b MASH Trial
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December 19, 2025 06:30 ET | Source: Altimmune, Inc
- Improvements observed in key non-invasive markers of fibrosis across treatment arms versus placebo, with continued reductions from 24-week timepoint
- Additional weight loss from 24 to 48 weeks with 1.8 mg dose, without plateauing
- Favorable tolerability profile of pemvidutide preserved at 48 weeks, reinforced by low treatment-related discontinuation rate
- End-of-Phase 2 meeting with FDA supports advancing to registrational Phase 3 trial in MASH patients with moderate to advanced liver fibrosis
Conference call to be held today at 8:00 a.m. ET
GAITHERSBURG, Md., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing therapies that address serious liver diseases, today announced positive topline results from the IMPACT Phase 2b trial of pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) at 48 weeks.
Topline 48-week data from the IMPACT trial showed that treatment with pemvidutide achieved statistically significant improvements across treatment arms in key non-invasive tests (NITs), including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), versus placebo. Importantly, these data exhibited continued reductions from week 24 and provide evidence of continued improvement in antifibrotic activity with both treatment doses. These are well-established markers of fibrosis and hepatic inflammation and are strongly associated with histological changes and liver related events. Additional weight loss was observed with the 1.8 mg dose compared to the IMPACT 24-week data, with no evidence of plateauing. The 48-week data also maintained the favorable tolerability profile seen at 24 weeks, including a lower discontinuation rate due to adverse events than placebo.
"The magnitude of response versus placebo on measures such as ELF and LSM at 48 weeks makes these data particularly compelling, as these noninvasive markers have been shown to correlate with histologic fibrosis stage. These results reinforce that pemvidutide may address both liver-specific and metabolic drivers of MASH without compromising tolerability – three critical elements of a potential effective treatment for this patient population," said Mazen Noureddin, M.D., IMPACT trial principal investigator, Professor of Medicine at Houston Methodist Hospital and Co-Chairman of the Board for Summit and Pinnacle Clinical Research. "I am encouraged by the dose response observed and the performance of the 1.8 mg arm and I am eager to see this differentiated therapeutic candidate advance into Phase 3 evaluation."
Highlights from the 48-Week Topline Results
• Pemvidutide-treated participants achieved statistically significant reductions in primary non-invasive markers of fibrosis, including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM).
o ELF: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of -0.49 and -0.58 respectively, vs. +0.16 in placebo-treated patients (p<0.0001, both doses).
o LSM: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of -3.04 (p<0.05) and -3.97 (p<0.001), respectively, vs. -0.03 in placebo-treated participants.
o The proportion of participants receiving pemvidutide 1.2 mg and 1.8 mg that achieved both a ≥0.5 reduction in ELF and a 30% reduction in LSM were 27.8% (p<0.001) and 32.4% (p<0.0001) respectively, vs. 3.2% in placebo-treated participants.
• Pemvidutide-treated participants also achieved statistically significant reductions in key non-invasive measures of liver health and hepatic inflammation, including liver fat content, alanine aminotransferase (ALT) and corrected T1 (cT1).
o Liver fat content: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of 45.2% and 54.7% respectively, compared to 8.2% in participants who received placebo (p<0.0001).
o ALT: 1.2 mg and 1.8 mg achieved a mean reduction from baseline of -37.8 IU/L and -37.4 IU/L respectively, vs. -10.3 IU/L in placebo-treated participants (p<0.0001, both doses).
o cT1: 1.2 mg and 1.8 mg achieved a mean reduction from baseline of -124 and -140 milliseconds (ms) respectively, vs. -21 ms in placebo-treated participants (p<0.0001, both doses).
• Participants receiving pemvidutide 1.2 mg and 1.8 mg achieved weight loss of 4.5% and 7.5%, respectively, vs. 0.2% of placebo-treated participants (p<0.0001, both doses), with no plateauing at 48 weeks with the 1.8 mg dose.
• Adverse events leading to treatment discontinuation occurred in 0% and 1.2% of patients treated with pemvidutide 1.2 mg and 1.8 mg, respectively, vs. 3.5% of participants on placebo.
• No serious or severe AEs related to treatment were reported.
Additionally, the Company announced that it held a productive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) which resulted in alignment on the parameters for a registrational Phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis. With the FDA's recent qualification of AIM-MASH AI Assist, the Agency was open to the Company's intent to integrate use of this AI tool into the Phase 3 trial. AIM-MASH AI Assist is intended to help standardize histologic assessment and reduce the time and resources needed for MASH drug development.
"With the benefit of FDA feedback and these 48-week data now in hand, we are greatly looking forward to progressing pemvidutide to a Phase 3 program which we intend to initiate in 2026. Strong evidence of antifibrotic improvements based upon non-invasive tests, combined with an attractive tolerability profile, highlight pemvidutide's differentiation and potential to be a meaningful treatment option for the MASH patient community," said Vipin Garg, Ph.D., Chief Executive Officer of Altimmune.
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