Two participants in the 80 mg BID arm had concomitant bilirubin elevations without alternative explanation. These elevations alone were not clinically significant, and virtually all participants were asymptomatic. Atuzaginstat was associated with dose-related liver enzyme elevations >3X the upper limit of normal: 2% on placebo, 7% on 40 mg BID, and 15% on 80 mg BID. 3% and 2% of placebo participants, respectively. The most common were gastrointestinal, such as diarrhea in up to 16% and nausea in 6% of participants treated with atuzaginstat vs. Most adverse events were mild to moderate in severity. “We are focused on next steps to advance this breakthrough treatment for the benefit of patients and their families.”
#ALTERNATIVES TO JST GAIN REDUCTION TRIAL#
The evidence from the GAIN Trial advances our ability to identify the right patients, impact an upstream target, and improve patient outcomes,” said Casey Lynch, Cortexyme’s chief executive officer, co-founder, and chair. “Today marks a major milestone toward a comprehensive understanding of Alzheimer’s and slowing of disease progression. Further results will inform the next stage of development in periodontitis and will be presented at a future scientific conference. The sub-study in periodontal disease demonstrated a trend to benefit on the primary clinical endpoint of pocket depth in the same pre-specified sub-group with P. gingivalis in saliva at week 24 were significantly correlated with improved outcomes at the end of the treatment period as measured by ADAS-Cog11 (p=0.0007), Clinical Dementia Rating–Sum of Boxes (CDR) (p=0.004), Mini-Mental State Exam (MMSE) (p=0.007), and a beneficial trend on ADCS-ADL (p=0.08). gingivalis infection was reinforced by similar results in multiple pre-specified infection related subgroups and with multiple methods of analysis. The cognitive benefit of atuzaginstat in patients with high P. Significant benefits in this subgroup were not seen on the other co-primary, ADCS-ADL. gingivalis DNA detectable in saliva at baseline (PG-DS n=242) showed a dose response, with a 57% slowing of cognitive decline as measured by ADAS-Cog11 in the 80 mg BID arm (p=0.02) and a 42% slowing in the 40 mg BID arm (p=0.07) vs. The pre-specified subgroup of participants with P. The 643-participant study in mild to moderate patients with Alzheimer’s disease did not meet statistical significance in its co-primary cognitive and functional endpoints as measured by ADAS-Cog11 and ADCS-ADL at end of the treatment period in the overall cohort. (Nasdaq: CRTX) today reported top-line results from its Phase 2/3 GAIN Trial, a double-blind, placebo-controlled study evaluating the efficacy of atuzaginstat (COR388), an investigational orally administered small-molecule that targets gingipain proteases from the bacterium Porphyromonas gingivalis ( P. – Additional top-line GAIN Trial results to be presented at CTAD 2021 on November 11 thĬortexyme to host investor conference call today Tuesday, October 26 th at 4:30 p.m. – Clinical data validated upstream mechanism of action and benefits of targeting P. gingivalis infection level showed approximately 50% slowing of cognitive decline – Pre-specified subgroups representing up to half of the participants based on P. – In overall population, co-primary endpoints of ADAS-Cog11 and ADCS-ADL were not met