Altimmune (ALT) Leerink Global Healthcare Conference 2026 summary

Recent clinical progress and regulatory milestones

• Two phase II MASH trial readouts in 2025 provided 24- and 48-week data, supporting the efficacy and tolerability of pemvidutide, and led to 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.

• Phase III MASH program will use a 52-week histology endpoint, with both 1.8 mg and 2.4 mg doses tested, and a simple titration scheme to enhance tolerability and efficacy.

• FDA feedback included support for AIM-MASH digital pathology tool and openness to non-invasive tests (NITs), with the study designed to pivot if regulatory acceptance evolves.

• Global regulatory alignment is in place with EMA and MHRA, ensuring the phase III protocol meets both US and European standards.

Differentiation and clinical data insights

• Pemvidutide’s balanced 1:1 GLP-1/glucagon agonism is unique, offering direct liver effects and strong metabolic benefits, with superior tolerability compared to competitors.

• Phase II data showed high patient retention, low discontinuation rates, and strong efficacy in MASH resolution and antifibrotic markers, especially with longer treatment duration.

• Subgroup analyses revealed consistent efficacy across fibrosis stages, genders, and diabetic status, with no unexpected safety signals.

• Glycemic control was maintained in both diabetic and non-diabetic patients, and no increase in heart rate was observed.

• The design allows for future combination therapy, leveraging pemvidutide’s tolerability and potential lean mass preservation.

Market positioning and future strategy

• Market research suggests clinicians will prioritize efficacy, tolerability, and weight loss quality when choosing incretin therapies for MASH.

• Pemvidutide is positioned as a strong monotherapy and a potential combination partner due to its safety profile and unique mechanism.

• The phase III study includes both biopsy-proven and NIT-identified cohorts, preparing for regulatory shifts toward non-invasive endpoints.

• Focus remains on F2/F3 fibrosis populations, with future evaluation of F4 (compensated cirrhotics) as resources allow.

• The company is actively considering combination regimens with other mechanisms, such as FGF-21 or THR-beta, to address diverse patient needs.