Healthcare Business

Is It Over for AC Immune After This Alzheimer's Study?

AC Immune S.A. (NASDAQ: ACIU) stock was absolutely crushed on Wednesday after one of the firm’s partners announced disappointing results from its midstage Alzheimer’s disease study. Genetech, a member of the Roche Group, was the company reporting the topline results.

The results come from the Phase 2 trial of the anti-Tau antibody, semorinemab, in early (prodromal to mild) Alzheimer’s. Unfortunately, semorinemab did not meet its primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo.

The two secondary endpoints, Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and Alzheimer’s Disease Cooperative Study Group – Activities of Daily Living Inventory (ADCS-ADL) were also not met.

The study followed 457 participants across 97 study centers. The study did not meet the primary efficacy endpoint of reducing decline on CDR-SB compared to placebo, but it did meet the primary safety endpoint.

Overall, the incidence of adverse events was similar between semorinemab and placebo arms, and further analysis of these safety data are currently underway.

Looking ahead, Genentech plans to present the results from the study at an upcoming medical congress. The second Phase 2 (LAURIET) study of semorinemab, in a different patient population, moderate Alzheimer’s, is ongoing.

While this news is surprising and disappointing, the firm is optimistic. Management believes the full data analysis of this first-of-its-kind study will yield information about this promising target that will advance the understanding and inform future efforts to successfully develop effective therapeutics for neurodegenerative diseases.

Despite this shortcoming, the firm has funding through the first quarter of 2024, and it is looking to its pipeline in the meantime.

AC Immune stock traded down about 43% to $4.98 on Wednesday, in a 52-week range of $4.07 to $13.00. The consensus price target is $12.58.