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AC Immune SA's (NASDAQ:ACIU) development partner has programmed the launch of a Phase 2b clinical study to evaluate ACI-35.030 (JNJ-64042056) in patients with preclinical Alzheimer's disease (AD), those individuals not yet showing symptoms.
ACI-35.030 is an investigational targeted active immunotherapy selective for pathological phosphorylated Tau (pTau).
Studies have shown that pTau correlates with AD progression, and the trial aims to show that ACI-35.030 can prevent or slow down the progression of tau pathology and the onset of clinical symptoms.
Under the licensing agreement with Janssen Pharmaceuticals Inc, a Johnson & Johnson (NYSE:JNJ) company, AC Immune will receive a milestone payment of CHF 15 million and another milestone payment of CHF 25 million related to achieving a non-disclosed enrollment target.
Approximately 500 participants with preclinical AD (cognitively normal, amyloid positive, Tau positive) will be randomized in a 1:1 ratio to a single dose level of ACI-35.030 or placebo and administered as intramuscular injections for a maximum of 4 years.
The primary endpoint will measure cognitive decline as assessed by the Preclinical AD Cognitive Composite 5 score, which combines tests that evaluate episodic memory, timed executive function, and global cognition.
The key secondary efficacy endpoint will assess the effect of ACI-35.030 on the propagation and/or accumulation of Tau pathology compared with placebo.
Concurrently, AC Immune priced an underwritten offering of 14.3 million at $3.50 per share, with gross proceeds of $50.1 million.
Price Action: ACIU shares are up 2.83% at $3.82 on the last check Friday.
