In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics, provides an update on the progress of Coya 302 as a treatment for ALS.
PE: Recently, Coya presented data from a study of Coya 302 for the treatment of ALS. Can you briefly describe what this data discovered?
Berman: First, let me say that Coya 302 is a combination of two different drugs. It's a low-dose IL-2, to enhance regulatory T cells, and CTLA-4, which is abatacept, which suppresses other pro inflammatory cell types. It's synergistic. We ran a proof of concept study for patients who were progressing relatively quickly, prior to treatment. We measured safety, tolerability, biomarkers, and the efficacy, which is the ALS FRS scale. That's the typical scale that is measured in ALS patients. At six months, we showed that instead of declining six or seven or eight points, which you would typically see, there was no decline in all four of our patients. Then at 12 months, where you would typically see a decline of maybe 14 points on the scale, there was only a very minor decline of 1.5 points. So, it means that the treatment is first of all reducing inflammation, reducing oxidative stress and different biomarkers we've discovered, and it seems to be well tolerated. It also seems to somehow slow or stop the progression of the disease. Of course, it's a small study, but we've seen it in all four patients. Correlating with the biomarkers, we're doing a larger trial, which is in process and we're filing the IND very soon.
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