- Cortexyme (NASDAQ:CRTX) said that its Phase 2/3 study for atuzaginstat (COR388) failed to reach main goals in a 643-participant study for patients with mild to moderate Alzheimer’s disease.
- At the end of the treatment for the overall cohort, the double-blind and placebo-controlled GAIN Trial did not reach co-primary cognitive and functional endpoints as measured by ADAS-Cog11 and ADCS-ADL with statistical significance, the company said.
- However, a pre-specified subgroup, consisting of about half of the trial participants based on P. gingivalis infection level, demonstrated a dose-response, indicating 57% slowing of cognitive decline.
- “The evidence from the GAIN Trial advances our ability to identify the right patients, impact an upstream target, and improve patient outcomes,” CEO Casey Lynch remarked.
- Most adverse events found in the study were mild to moderate in severity and gastrointestinal in nature, the company said. However, the experimental therapy was linked to dose-related liver enzyme elevations, implying over three times the upper limit of normal.
- Additional top-line data from the trial are expected on Nov. 11 at the upcoming 14th Clinical Trials on Alzheimer's Disease (CTAD 2021) conference.
In September, Citi opened a negative catalyst watch on the stock ahead of the data readout.