AC Immune's ACI-7104 Hits All Primary Endpoints in Phase 2 Parkinson's Trial
ACIU sits 30% above its 52-week low of $2.095 on light trading volume (0.4× avg).
Summary
AC Immune's ACI-7104 met all primary endpoints in Part 1 of its Phase 2 Parkinson's trial, showing strong immunogenicity and target engagement signals, with FDA discussions planned for early 2027.
Key Events · Product Development and Regulatory · ACIU
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All Primary Endpoints Met
Week-100 data from Part 1 of VacSYn showed ACI-7104 was safe, well-tolerated, and strongly immunogenic in 34 patients with early-stage Parkinson's disease.
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100% Antibody Response Rate
All 25 patients receiving ACI-7104 developed antibodies against the alpha-synuclein target antigen PD01 after three immunizations.
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CSF Penetration and Target Engagement
Antibodies penetrated the cerebrospinal fluid in all patients, and a signal for total alpha-synuclein in CSF provides preliminary evidence of target engagement.
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FDA Discussions Planned Early 2027
The company will submit the final Part 2 design to the FDA, with meetings expected in early 2027 to advance toward a Phase 3 decision.
Analysis · ACIU · Life Sciences
Positive week-100 data from Part 1 of the VacSYn Phase 2 trial of ACI-7104 in early-stage Parkinson's disease were reported. All primary endpoints were met: the drug was safe and well-tolerated, and 100% of patients developed antibodies after three immunizations. Antibodies penetrated the cerebrospinal fluid in all patients, and a signal for total alpha-synuclein in CSF suggests the drug is engaging its target. This is the first complete dataset from the trial and strengthens the case for advancing to Part 2, with FDA discussions planned for early 2027. The results de-risk the program and support the company's wholly owned pipeline strategy.
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At the time of this filing, ACIU was trading at $2.73 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $277.8M. The 52-week trading range was $2.10 to $4.00. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.