Coya Therapeutics CEO Dr Howard Berman joined Steve Darling from Proactive to share news regarding the company's recent financial results and developments. Notably, Coya Therapeutics presented positive outcomes from a proof-of-concept clinical study involving low-dose interleukin-2 (ld IL-2) in patients with Amyotrophic Lateral Sclerosis (ALS) during the second quarter.
The study revealed several encouraging findings, including enhanced Treg (T-regulatory cell) function during treatment, a halt in disease progression at the 24-week mark, and minimal decline at 48 weeks. Additionally, the treatment appeared to be well-tolerated by the patients. These promising results were presented at the 2023 Muscular Dystrophy Association Conference.
Coya Therapeutics also shared the results from an open-label clinical study involving ld IL-2 in patients with mild to moderate Alzheimer's Disease. During the four-month treatment period, the therapy enhanced Treg function and numbers, showed good tolerability, and resulted in a statistically significant improvement in mean MMSE scores compared to baseline. These findings are significant for potential Alzheimer's Disease treatments.
Dr Berman expressed the company's belief in the potential of their proof-of-concept clinical data and revealed plans for a pre-IND (Investigational New Drug) meeting with the FDA in the upcoming fall of 2023. The company aims to have its IND application for a phase 2 trial accepted by the FDA in early 2023, with the optimism of commencing the trial soon after acceptance.