COYA 302 efficacy shows improvement in ALS disease

Coya Therapeutics, Inc. COYA reported 48 week clinical data for its proof-of- concept open-label study in 4 ALS patients, showing that treatment with COYA 302 appeared to improve disease progression, leaving progression in all patients at 24 weeks with minimal decline at 48 weeks. This was in a patient cohort that was declining prior to entry into the study.

Four ALS patients with a mean decline of 1.1 points month in the Revised ALS Functional Rating Scale ALSFRS-R score prior to study initiation, were treated for 48 consecutive weeks with COYA 302 and were evaluated for safety and tolerability, treg suppressive function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the ALSFRS-R scale. Patients were evaluated over an 8 week washout period after the administration of COYA 302 for 48 weeks.

During the 48 week treatment period, COYA 302 appeared to be well tolerated. The most common adverse event was mild injection-site reactions. No patients stopped the study, and no deaths or other serious adverse events were reported.

Preliminary efficacy of COYA 302 was measured by the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in patients with ALS. The mean SD ALSFRS-R scores at week 24 33.75 3.3 and week 48 32 7.8 after the initiation of treatment with COYA 302 were not statistically different compared to the baseline 33.5 5.9 indicating significant improvement in the progression of the disease over the 48 week treatment period.

The trig suppressive function, expressed as the percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the course of the treatment period and was significantly reduced at the end of the 8 week washout post-treatment period. Treg suppressive function at 24 weeks 79.9 9.6 and 48 weeks 89.5 4.1 were significantly higher compared to baseline 62.1 8.1 p 0.01 suggesting an enhanced and durable Treg suppressive function over the course of treatment. In contrast, the Treg suppressive function mean that SD was significantly decreased at the end of the 8 week washout period compared to end-of-treatment at week 48 70.3 8.1 vs. 89.5 4.1, p 0.05 The study also evaluated serum biomarkers of inflammation, oxidative stress and lipid peroxides. The available data shows a decrease of these biomarker levels up to 16 weeks after the initiation of treatment, which is consistent with the observed enhancement of the Treg function. The full biomarker data is being evaluated.

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