Coya Therapeutics Reveals Proof-of-Concept Data From Small Study With ALS Patients

Coya Therapeutics Inc COYA 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.
Price Action: COYA shares are up 4.95% at $4.24 on the last check Tuesday.

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