Coya Therapeutics' Manuscript Accepted by Frontiers in Neurology

Coya Therapeutics, Inc. (NASDAQ: COYA), a clinical-stage biotechnology company, has announced the acceptance of a peer-reviewed manuscript titled “A Phase 1 Proof-of-Concept Study Evaluating Safety, Tolerability, and Biological Marker Responses with Combination Therapy of CTLA4-Ig and Interleukin-2 in Amyotrophic Lateral Sclerosis” in the medical journal Frontiers in Neurology. The study explores the safety, tolerability, and biological marker responses to a combination therapy involving CTLA4-Ig Fusion Protein and Low Dose Interleukin-2 (LD IL-2) in patients with Amyotrophic Lateral Sclerosis (ALS).

COYA 302 is an investigational biologic combination therapy designed to enhance the anti-inflammatory function of regulatory T cells (Tregs) and inhibit inflammation from activated monocytes and macrophages. The therapy combines proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig for subcutaneous administration, targeting ALS, Frontotemporal Dementia (FTD), and Parkinson’s Disease (PD).

In February 2023, Coya revealed results from a proof-of-concept, open-label clinical study conducted at Houston Methodist Research Institute by Dr. Stanley Appel and his team. The study assessed the effects of commercially available LD IL-2 and CTLA-4 Ig on a small cohort of ALS patients. The patients received the investigational treatment for 48 weeks and were monitored for safety, tolerability, Treg function, serum biomarkers of oxidative stress and inflammation, and clinical functioning using the ALSFRS-R scale.

Throughout the 48-week treatment, the therapy was well tolerated with mild injection-site reactions being the most common adverse event. No patients discontinued the study, and there were no serious adverse events or deaths reported. Disease progression, as measured by the ALSFRS-R scale, indicated significant amelioration over the 48-week period, with mean ALSFRS-R scores at week 24 and week 48 showing no statistically significant difference from the baseline.

The study highlighted a significant increase in Treg suppressive function over the treatment period, which was measured by the percentage inhibition of proinflammatory T cell proliferation. This function was significantly improved at both 24 and 48 weeks compared to baseline and was notably reduced after an 8-week washout post-treatment period.

Additionally, the study examined serum biomarkers related to inflammation, oxidative stress, and lipid peroxides, noting a decrease in these levels, which aligns with the observed enhancement in Treg function. The comprehensive evaluation of biomarker data is ongoing.

ALS, also known as Lou Gehrig's Disease, is a rare and progressive neurological condition affecting motor neurons responsible for voluntary muscle movement. Approximately 20,000 individuals in the United States live with ALS, and around 5,000 new cases are diagnosed annually. The disease leads to muscle weakness, twitching, and atrophy, eventually resulting in the inability to control voluntary movements. Most ALS patients succumb to respiratory failure within three to five years from symptom onset.

Coya Therapeutics is based in Houston, Texas, and focuses on developing treatments that leverage the therapeutic advantages of regulatory T cells to target systemic and neuroinflammation. Their investigational pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. COYA 302, their lead investigational product, is intended for the treatment of ALS, FTD, PD, and Alzheimer's Disease, with a multi-targeted approach that aims to restore immune balance and mitigate inflammation more effectively than individual treatments alone.

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