Coya shares plummet on Phase 2 Alzheimer's drug results

Coya Therapeutics experienced a notable decline in its stock price, $COYA, plummeting more than 20% on Tuesday following the announcement of Phase 2 data pertaining to its Alzheimer’s disease treatment program, COYA 301. Despite having reduced the focus on COYA 301 during a research and development reorganization last year, Coya Therapeutics is still investigating its efficacy when combined with other therapies.

COYA 301, an IL-2, is designed to enhance the anti-inflammatory function of regulatory T cells (Tregs). The recent study aimed to assess the drug’s safety and its ability to increase the number of Tregs in patients. A total of 38 patients participated in the study, divided into two cohorts: one receiving doses every four weeks and another every two weeks, with each cohort including a placebo group.

After a 30-week period, the results indicated that the four-week dosing regimen of COYA 301 led to significant increases in certain regulatory T cells, specifically CD4+ FOXP3+CD25 high Tregs, with a p-value of p<0.05. Conversely, the two-week dosing regimen did not exhibit statistically significant differences compared to the placebo group.

The study's results in terms of cognitive improvement, a key indicator for Alzheimer’s disease, remain uncertain. Coya Therapeutics evaluated the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) and, although the study was not designed to achieve statistical significance, noted a slight improvement with a 4.93-point difference between the four-week dose and the placebo groups. However, this result was not statistically significant, with a p-value of 0.061.

During a conference call on Tuesday morning, company executives mentioned that Coya is continuing to explore the potential of COYA 301 in combination with other therapies. Additionally, the company is advancing an IL-2/CTLA-4 program, COYA 302, which is undergoing testing for its effectiveness in treating ALS, frontotemporal dementia, and Parkinson’s disease.