Coya Has Proof-of-Concept Data From Small Study With ALS Patients
- Coya Therapeutics Inc reported 48-week clinical data for its proof-of-concept open-label study in 4 Amyotrophic Lateral Sclerosis (ALS) patients indicating that treatment with COYA 302 appeared to ameliorate disease progression.
- During the 48-week treatment period, COYA 302 appeared to be well tolerated.
- Preliminary efficacy of COYA 302 was measured by the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in ALS patients.
- The mean (±SD) ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of COYA 302 treatment were not statistically different compared to the ALSFRS-R score at baseline (33.5 ±5.9), indicating significant amelioration in the progression of the disease over the 48-week treatment period.
- Treg suppressive function, expressed as a percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the treatment period and was significantly reduced at the end of the 8-week washout post-treatment period.
- The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides.
- The available data up to 16 weeks suggest a decrease of these biomarker levels, which is consistent with the observed enhancement of Treg function.
- The evaluation of the complete biomarker data is ongoing.
- The company said it plans to file an IND with the FDA in the second half of 2023 and initiate a clinical study soon after.
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