AC Immune (NASDAQ: ACIU) shares are rallying premarket after the company announced Genentech, a member of the Roche Group, has informed it that Lauriet, a placebo-controlled Phase 2 study evaluating the investigational anti-tau monoclonal antibody, semorinemab, in mild-to-moderate Alzheimer’s disease (AD), met one of its co-primary endpoints.
However, it failed to meet its second co-primary endpoint.
Semorinemab demonstrated a statistically significant reduction in cognitive decline from baseline by 43.6% compared to placebo. In addition, safety data showed that semorinemab is well tolerated with an acceptable safety profile and no unanticipated safety signals.
There was no effect on the other co-primary endpoint of reducing the rate of functional decline from baseline.
The open-label portion of the study will continue along with further analysis, while top-line data submitted for presentation in November.
Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “The top line results of the Lauriet Phase 2 clinical trial of semorinemab are remarkable in that it is the first time we have seen a therapeutic effect by a monoclonal anti-Tau antibody therapy. We also are excited by the fact that this is the first time a monoclonal antibody has had a therapeutic impact on cognition in the mild-to-moderate AD patient population.
“Nevertheless, despite these interesting results, we are still cautious about what this may mean for patients as there was not an impact on the rate of functional decline or other efficacy endpoints.”
AC Immune's share price has surged 73.96% premarket to $12.16.
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