| IMPACT MASH primary endpoint: MASH resolution without fibrosis worsening (24 weeks, ITT) | 1.2mg pemvidutide weekly | 59.1% MASH resolution at week 24 vs 19.1% placebo (p<0.0001); met the primary endpoint |
| IMPACT MASH primary endpoint: MASH resolution without fibrosis worsening (24 weeks, ITT) | 1.8mg pemvidutide weekly | 52.1% MASH resolution at week 24 vs 19.1% placebo (p<0.0001); resolution was not dose-ordered (the 1.2mg arm scored numerically higher than 1.8mg) |
| IMPACT MASH secondary endpoint: fibrosis improvement >=1 stage without MASH worsening (24 weeks, ITT) | 1.2mg / 1.8mg vs placebo | 31.8% (1.2mg) and 34.5% (1.8mg) vs 25.9% placebo at week 24; differences were not statistically significant (the trial was not powered for fibrosis improvement at this 24-week duration) |
| IMPACT MASH liver fat reduction (MRI-PDFF, 24 weeks) | 1.2mg / 1.8mg vs placebo | 58.0% (1.2mg) and 62.8% (1.8mg) relative reduction in liver fat vs 16.2% placebo (p<0.001 both doses) |
| IMPACT MASH weight loss (secondary endpoint, 24 weeks) | 1.2mg / 1.8mg vs placebo | -5.0% (1.2mg) and -6.2% (1.8mg) mean weight loss vs -1.0% placebo at 24 weeks (p<0.001 both doses) |
| IMPACT MASH 48-week extension (weight loss) | 1.2mg / 1.8mg vs placebo | Dec 2025 readout: -4.5% (1.2mg) and -7.5% (1.8mg) mean weight loss vs -0.2% placebo at 48 weeks (p<0.0001 both doses), with no weight-loss plateau at the 1.8mg dose. The primary histology endpoints were assessed at 24 weeks; the 48-week data covered secondary and non-invasive markers (ELF, liver stiffness) |
| IMPACT MASH tolerability | Adverse-event discontinuations | 0.0% (1.2mg) and 1.2% (1.8mg) vs 2.4% placebo; among the lowest discontinuation rates reported for an incretin in MASH |
| MOMENTUM obesity Phase 2 (48 weeks): high-dose cohort | 2.4mg pemvidutide weekly | Nov 2023 topline: 15.6% mean weight loss at 48 weeks at the high dose; competitive with semaglutide STEP 1 (~14.9% at 68 weeks). GI tolerability profile broadly comparable to other GLP-1 agonists |
| PERFORMA MASH Phase 3 (pivotal, registrational) | Phase 3 program | PERFORMA Phase 3 trial planned to initiate 2H 2026 (Altimmune EASL 2026 update); pivotal MASH biopsy + fibrosis-improvement co-primary endpoints; FDA Fast Track + Breakthrough Therapy Designation granted for MASH. Competing with Rezdiffra (already approved March 2024), survodutide (Phase 3), and semaglutide in MASH (FDA-approved August 2025) |
| MOMENTUM Phase 3 obesity (registrational) | Phase 3 program | Pivotal trial design + dose selection finalizing 2025; supports a separate obesity FDA filing pathway; target launch 2029-2030 if approved |
| Editorial. Why ALT matters | Strategic context | Altimmune is the smallest standalone biotech with parallel MASH + obesity Phase 3 ambitions. The dual GLP-1/glucagon mechanism is mechanistically distinct, but the development timeline (2028-2029 launches) puts ALT well behind the commercial-stage leaders. Pemvidutide MASH faces a crowded competitive field: Rezdiffra (oral, mechanistically distinct THR-beta), semaglutide (approved for MASH), survodutide (Phase 3), efruxifermin (AKRO, FGF21). The strategic question: standalone commercial launch vs acquisition (NVO + Roche + Boehringer have all been speculated as potential acquirers given the dual-mechanism asset profile) |
Altimmune