Atea Pharmaceuticals (AVIR) 7th Annual Evercore ISI HealthCONx Healthcare Conference summary

Key clinical data and program updates

• Phase 2 trials of bemnifosbuvir and ruzasvir in HCV showed 98% SVR12 in adherent patients and 95% in all patients, with robust efficacy across genotypes and strong drug forgiveness.

• Non-cirrhotic patients achieved up to 99% SVR12 after 8 weeks, while cirrhotic patients had 88% SVR12, with plans for a 12-week regimen in this group for phase 3.

• High prevalence of NS5A mutations (up to 90%) was observed, yet robust viral clearance was achieved.

• Safety profile was favorable, with no serious drug-related adverse events or discontinuations; adverse events were generally mild to moderate.

• End-of-phase-2 FDA meeting is planned for early Q1 2025 to finalize the global phase 3 program.

Market and regulatory outlook

• HCV market remains significant, with $3 billion in annual sales and potential for $20–30 billion in total market value based on patient numbers and therapy costs.

• Barriers to treatment initiation persist, including insurance restrictions and delays between diagnosis and therapy.

• Government initiatives and the opioid crisis are expected to drive further market growth and support eradication efforts.

• The regulatory path is considered straightforward, with broad patent coverage until at least 2042 and potential for extension.

• The company is prepared to advance phase 3 independently but remains open to partnerships for commercialization.

Insights on patient adherence and drug forgiveness

• Majority of non-adherent patients still achieved SVR12, highlighting the regimen's drug forgiveness.

• Dropout rates increase after the first month, but early potent viral suppression is key to high cure rates.

• Few cases of viral rebound or resistance were observed, with ongoing analysis of resistance mutations.

• The regimen's short duration, low risk of drug-drug interactions, and no food effect address unmet needs in younger, less adherent populations.

• Fixed-dose, convenient regimens are expected to further improve adherence and outcomes.