View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
September 1, 2021

AC Immune reports positive data from Alzheimer’s disease drug trial

Semorinemab was well-tolerated and had a tolerable safety profile in the Phase II trial.

AC Immune has reported that an experimental drug, semorinemab, met one of the co-primary goals, ADAS-Cog11, of the Phase II Lauriet clinical trial in mild-to-moderate Alzheimer’s disease (AD) patients.

An anti-tau monoclonal antibody, semorinemab is currently being developed by Genentech and was discovered in partnership with AC Immune .

It acts on the N-terminal portion of the tau protein and can potentially attach to the protein to reduce its spread between neurons.

The double-blind, placebo-controlled, randomised Phase II trial analysed the safety and efficacy of semorinemab against placebo in 272 adults with mild-to-moderate AD enrolled at 43 sites across the world.

The change from baseline at week 49 in cognition as assessed by the Alzheimer’s Disease Assessment Scale, Cognitive Subscale, 11-Item Version (ADAS-Cog11) was one of the co-primary goals.

The other co-primary endpoint was the change from baseline in daily activities as evaluated by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale.

The trial analysed cognitive and functional measures as secondary goals.

Findings showed that semorinemab offered a statistically significant 43.6% decrease in cognitive decline from baseline versus placebo.

The co-primary endpoint of ADCS-ADL was not met in the trial.

As per the top-line data from the trial, the drug was demonstrated to be well-tolerated with a satisfactory safety profile without any unexpected safety signals.

Furthermore, these safety results were in line with already reported data.

AC Immune CEO professor Andrea Pfeifer said: “The top-line results of the Lauriet Phase II 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.

“We look forward to additional data from our other clinical-stage Tau programmes: Tau vaccine ACI-35, partnered with Janssen ; and the small molecule Morphomer Tau aggregation inhibitor, partnered with Eli Lilly .”

The open-label portion of the Lauriet trial will progress as planned, Genentech noted.

Additional assessments are underway with top-line results anticipated in November this year.

Apart from the Lauriet trial, semorinemab was evaluated in the Phase II Tauriel study involving early (prodromal-to-mild) AD patients.

The Tauriel study failed to meet the primary efficacy goal, AC Immune and Genentech reported in September 2020.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Clinical Trials Arena