Altimmune, Inc.

Company overview

Altimmune, Inc. is a late clinical-stage biopharmaceutical company focused on pemvidutide (formerly ALT-801), a balanced 1:1 glucagon/GLP-1 dual receptor agonist. The lead clinical development program targets metabolic dysfunction-associated steatohepatitis (MASH), with additional programs in alcohol use disorder (AUD) and alcohol-associated liver disease (ALD).

Lead asset — pemvidutide

• Dual glucagon receptor and GLP-1 receptor agonist with 1:1 potency.
• Intended effects:
  • Liver-directed: reductions in liver fat, inflammation, and fibrosis progression.
  • GLP-1–mediated: appetite suppression, weight loss, and reductions in cravings.
• Competitive positioning: Altimmune emphasizes the balanced 1:1 activity as a clinical differentiator that couples liver-directed and metabolic benefits.

History and platform

• Pemvidutide was acquired through the July 2019 Spitfire Pharma, Inc. acquisition.
• EuPort technology (surfactant-functionalized incretin peptides), licensed from Mederis Diabetes, LLC, is the platform used for pemvidutide and related peptides.
• Altimmune holds an exclusive license to develop and commercialize EuPort-enabled GLP-1/glucagon peptides for pemvidutide and related indications.

Intellectual property and collaborations

• Patent estate covers EuPort claims and pemvidutide-specific uses, formulations, dosing regimens, weight loss, cardiovascular risk reduction, and liver disease applications, with expirations extending into the 2030s–2040s (subject to extensions and national term adjustments).
• Patents and applications exist in the US, Europe, Japan, Korea, Australia, Mexico and other jurisdictions.
• Collaboration with Adocia S.A. (Dec 24, 2024) grants exclusive rights to oral administration of pemvidutide; related patent term dates extend into the 2040s.

Regulatory designations

• FDA Breakthrough Therapy Designation for MASH.
• FDA Fast Track designation for MASH.
• FDA Fast Track designation for AUD (granted Aug 2025).

Clinical development status and milestones

• IMPACT (Phase 2b, MASH):
  • 24-week data: 212 subjects with biopsy-confirmed MASH (F2/F3, with/without diabetes); weekly 1.2 mg and 1.8 mg doses vs placebo.
  • Intent-to-treat (24-week) results: MASH resolution without worsening fibrosis in 58.2% (1.2 mg) and 52.1% (1.8 mg) vs 19.9% for placebo (p<0.0001 for both doses).
  • Fibrosis improvement without worsening: 32.6% (1.2 mg) and 35.7% (1.8 mg) vs 27.9% placebo (not statistically significant).
  • AI-assisted analysis: 31% of 1.8 mg patients achieved ≥60% fibrosis reduction vs 8% placebo (p<0.001).
  • Safety: low discontinuation rates due to adverse events (<1% for 1.2 mg; 1.2% for 1.8 mg) and no serious drug-related adverse events reported.
• IMPACT 48-week topline (Dec 2025):
  • Improvements in ELF and liver stiffness measurement (LSM) versus placebo; reductions in liver fat, ALT, and cT1.
  • Continued, dose-responsive weight loss at 48 weeks: 4.5% (1.2 mg) and 7.5% (1.8 mg) vs 0.2% placebo.
  • Safety profile remained favorable with low discontinuation due to adverse events.
• Regulatory interactions:
  • End-of-Phase 2 meeting with FDA (Dec 2025); meeting minutes finalized Jan 2026.
  • Phase 3 plan: a 52-week pivotal, biopsy-driven MASH trial is planned to begin in 2026.
  • FDA-qualified AIM-MASH pathology assist tool approved for use in the Phase 3 MASH trial.
  • European regulatory engagement ongoing to align on the final Phase 3 protocol.

Additional clinical programs

• AUD — RECLAIM (Phase 2):
  • Randomized, placebo-controlled trial (~100 subjects; ~15 sites in the US).
  • Started May 2025; enrollment completed Nov 2025.
  • Primary endpoint: change in heavy drinking days per week at Week 24.
  • Topline results expected in 2026.
• ALD — RESTORE (Phase 2):
  • ~100 patients across ~34 sites; started July 2025.
  • 24- and 48-week outcomes include LSM by VCTE, ELF, alcohol use measures, and body weight.

Clinical exposure and program scale

• As of Dec 31, 2025: over 700 patients exposed to pemvidutide across 8 completed studies and 2 ongoing studies.

Strategic focus

• Advance a registrational Phase 3 MASH program in 2026 based on anti-inflammatory/anti-fibrotic signals, weight loss, and tolerability.
• Continue development in AUD and ALD, using dual GLP-1/glucagon activity to address liver and metabolic components.
• Optimize formulation, dose, and presentation and pursue strategic partnerships or licensing to accelerate development and commercialization.

Regulatory and market context

• US pathway: IND-to-NDA/BLA with potential expedited programs (Fast Track, Breakthrough Therapy, accelerated approval) and potential post-approval commitments.
• EU/UK: Clinical Trials Regulation 536/2014 applies; ongoing scientific and regulatory alignment for Phase 3.
• Competitive landscape includes major pharma and other biotech programs across GLP-1, GIP, glucagon, FGF-21, THRβ, and other metabolic and liver-targeted mechanisms.

Bottom-line summary

Altimmune is developing pemvidutide, a balanced GLP-1/glucagon dual agonist, primarily for MASH with parallel programs in AUD and ALD. The company uses EuPort surfactant-based peptide technology licensed from Mederis and maintains a patent portfolio covering pemvidutide and related applications into the 2030s–2040s. Positive Phase 2 signals, regulatory interactions, and planned Phase 3 initiation in 2026 define the near-term clinical and regulatory roadmap.