Image Source: Unsplash

Coya Therapeutics (COYA), a clinical-stage biotech that focuses on regulatory T-cells to develop therapies for neurodegenerative, metabolic, and autoimmune diseases, released data from their open-label study evaluating the safety and tolerability of COYA 301 in 8 patients with Alzheimer’s disease (AD). The trial was an investigator-initiated study conducted by Dr. Appel and Dr. Faridar at the Houston Methodist Hospital, where the patients had confirmed the presence of brain amyloid pathology and baseline MMSE scores between 12 and 25.

I highlighted this trial as a potential catalyst in my first article as the valuation of the company did not even fully appreciate the ALS data let alone the potential in AD. The trial is not only important in terms of speaking to the potential in AD, but it can establish consistency of data across trials and indications. The more that a result becomes replicated, the more confidence one can have the signals are real.

The patients in the trial were treated with five-day courses of COYA 301 for four monthly cycles and were followed for two months. Treatment with COYA 301 generated a statistically significant (p=0.015) improvement in mean MMSE scores during the treatment phase (compared to the mean MMSE score at baseline). In addition, the ADAS-Cog and CDR-SB scales did not significantly change by the end of treatment, which indicates no cognitive decline.

While the effect on MMSE is important, what makes the data even more interesting is the impact on Tregs. Why? The proposed mechanism of action is linked to increases in Tregs and showing both an effect on MMSE as well as increases in Tregs would indicate the drug works exactly as expected (making the replication of these results in larger trials more likely).

The baseline mean percentage of Tregs was 4.55, which almost doubled to 8.68 by the end of treatment and that was a statistically significant increase (p=0.0004). In terms of mean Treg suppressive function, it started at 46.61%, and significantly increased to 79.5 % by the end of treatment (p=0.003). The drug clearly was having the predicted effect on Tregs and when combined with the impact on MMSE, it looks quite encouraging.

Coya now has a positive trial in ALS and AD, where both trials showed the predicted effects on Tregs and the concomitant impact on the respective diseases. As I noted before, the valuation did not reflect the (admittedly early) data in ALS and that is even more the case with the AD data. The continued demonstration of efficacy across these and potentially other neurodegenerative diseases will significantly revalue the company even from these levels.

The Coya story is just beginning and as the company expands with larger trials, the success in those trials will only increase the valuation of the company. It was an attractive risk/reward after the ALS data and before the AD data and it remains so as the market is not properly valuing both the data or the potential of confirming these results in larger trials.

More By This Author:

Sarepta: The AdCom Documents Enter The Discussion
Another Sucess In Alzheimer’s Disease
Biogen On The Hunt