USFDAAug 11, 2026, 07:01 AM
AC Immune ACI-7104 Gets FDA Fast Track & IND for Parkinson's
AI Summary
AC Immune SA announced that its anti-alpha-synuclein active immunotherapy candidate, ACI-7104, received FDA Fast Track designation and Investigational New Drug (IND) clearance for early Parkinson's disease. This allows the ongoing Phase 2 VacSYn study to expand to sites in the USA. Recent positive interim results from the VacSYn trial demonstrated safety, tolerability, and immunogenicity, with full Part 1 results anticipated in H2 2026. The company views these regulatory milestones as crucial steps towards addressing the significant unmet need in Parkinson's disease.
Key Highlights
- AC Immune received FDA Fast Track designation for ACI-7104 for early Parkinson's disease.
- FDA also cleared the Investigational New Drug (IND) application for ACI-7104.
- ACI-7104 is an anti-alpha-synuclein active immunotherapy candidate.
- The ongoing Phase 2 VacSYn study will expand to sites in the USA.
- Recent interim results showed ACI-7104 was safe, well-tolerated, and immunogenic with a 100% responder rate.
- Full week-100 results from Part 1 of the VacSYn trial are expected in H2 2026.
- A $4 million research grant supports the extension of Part 1 of the VacSYn trial for two additional years.
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