Cortexyme Inc. (CRTX) stock prices were down by 2.68% as of the market closing on October 26th 2021. This brought the price per share down to USD$57.68. Subsequent after hours fluctuations saw the stock plummet by 70.04%, bringing it down to USD$17.28.
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CRT Stock’s GAIN Trial Results
October 26th 2021 saw CRTX stock report top-line results from its Phase 2/3 GAIN trial. The double blind, placebo controlled trial was designed to evaluate the efficacy of COR388. The atuzaginstat treatment is an investigational orally administered small molecule that targets gingipain proteases from the P. gingivalis bacterium. The trial enrolled 643 participants with mild to moderate Alzheimer’s disease. the company reported that the trial failed to meet statistical significance in its co=primary cognitive and functional endpoints. These endpoints were measured by ADAS-Cog11 and ADCS-ADL at the end of the treatment period in the overall cohort.
Details of the Trial
Most of the adverse events observed were mild to moderate in severity, with most being gastrointestinal in nature. These adverse events included diarrhea in up to 16% of the patient population and nausea in 6% of participants that were given the COR388 treatment. This is compared to 3% and 2% observed in placebo participants, respectively. The treatment was associated with dose-related liver enzyme elevations more than three times the upper limit of normal. The elevations were reported at 2% for the placebo, 7% on 40 mg BID, and 15% on 80 mg BID. These elevations by themselves were not clinically significant. Nearly all of the participants were asymptomatic.
CRTX Stock’s Pioneering Study
The first large clinical study of a gingipain inhibitor consolidated the benefits of treatment in relevant population at doses that served to reduce P. gingivalis. The GAIN trial demonstrated disease modification and preservation of cognition, which serve as the foundation for the alteration of the course of Alzheimer’s.
Moving Past Disappointment
The participant population infected with P. gingivalis was easily identified with saliva or simple blood tests. This population was highly responsive to atuzaginstat treatment on multiple clinical measures, with further steps being discussed with global regulatory authorities.
Future Outlook for CRTX Stock
CRTX stock is keen to strategize its next steps following this disappointing development. The company is poised to utilize the knowledge and resources gained over the course of the GAIN trial in a bid for its next steps to bring the company back to its trajectory of success. Current and potential investors are hopeful that management will be able to effectively leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value over the long term.
