AC Immune has received Fast Track designation and clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) for its anti-alpha-synuclein (a-syn) active immunotherapy candidate, ACI-7104, for the treatment of early-stage Parkinson’s disease (PD). 

ACI-7104 is designed to induce a-syn-specific antibodies, preferentially recognising aggregated a-syn species that are toxic to neurons.  

The candidate is currently being investigated in the VacSYn Phase II trial, an adaptive, biomarker-based study in patients with early-stage Parkinson’s disease, with final Part 1 week-100 results on track to be announced in H2. 

Martin Zügel, interim CEO of AC Immune SA, commented: “Fast Track designation and IND clearance from the FDA are important achievements for ACI-7104, one of our wholly-owned programs, given its potential to address the significant unmet need in Parkinson’s. We look forward to working closely with the FDA as we advance ACI-7104 through its ongoing clinical development towards potentially delivering a much-needed treatment option for patients.” 

Early interim Phase II data have demonstrated safety, tolerability and immunogenicity, as well as the first signals that targeting underlying a-syn pathology with an active immunotherapy could potentially impact PD. The interim results, reported for Part 1 of the study at 76 weeks, successfully demonstrated ACI-7104 was safe and well tolerated, with no clinically relevant safety issues being reported. Targets were also met for immunogenicity with a 100% responder rate.  

AC Immune recently announced a $4 million research grant from the Vijay and Marie Goradia Charitable Foundation to support the extension of Part 1 of the VacSYn trial, enabling the assessment of long-term safety and efficacy of ACI-7104 for an additional two years.