Altimmune (ALT) Leerink Global Healthcare Conference 2026 summary

Recent clinical progress and data highlights

• Two phase II MASH trial readouts in 2025 provided 24-week and 48-week data, showing promising efficacy and tolerability for pemvidutide, with breakthrough therapy designation and FDA alignment on phase III design.

• Ongoing phase II trials in alcohol use disorder (AUD) and alcohol-related liver disease (ALD) are expected to deliver top-line data and complete enrollment in 2026.

• Pemvidutide demonstrated a unique 1:1 GLP-1/glucagon agonism, offering balanced metabolic and liver effects, with superior tolerability and lower discontinuation rates compared to competitors.

• Phase II data showed strong MASH resolution and antifibrotic trends, with continued improvement at 48 weeks on non-invasive markers, supporting a 52-week endpoint for phase III.

• Subgroup analyses revealed consistent efficacy and tolerability across F2, F3, gender, and diabetic status, with no outlier populations.

Phase III program design and regulatory alignment

• Phase III will use a simple titration scheme to improve tolerability and enable testing of a higher 2.4 mg dose, aiming for added efficacy and weight loss.

• The primary endpoint is histology at 52 weeks, with the AIM-MASH digital pathology tool incorporated to reduce variability and potentially improve endpoint robustness.

• The study includes both biopsy-proven and NIT-identified cohorts, collecting comprehensive non-invasive test data to adapt if regulatory acceptance of NITs evolves.

• FDA and European regulators are aligned on trial design, supporting a global development strategy.

• Focus remains on F2/F3 populations, with potential future expansion to F4 (compensated cirrhotics) as resources allow.

Differentiation, market positioning, and future directions

• Pemvidutide's tolerability and balanced mechanism position it as a strong candidate for chronic MASH therapy, with potential for use as monotherapy or in combination regimens.

• Lean mass preservation and safety profile may make it preferable for patients at risk of sarcopenia or with multiple comorbidities.

• Market research suggests efficacy, tolerability, and ability to keep patients on therapy will drive clinician choice among incretin options.

• The MASH market is expected to evolve into a multi-mechanism, chronic therapy landscape similar to diabetes, with opportunities for both oral and injectable agents.

• Ongoing research will explore combination strategies and further differentiation in real-world patient populations.