HOUSTON - Coya Therapeutics, Inc. (NASDAQ: COYA), a biotech firm focused on treatments for neurodegenerative diseases, has announced the expansion of its therapeutic pipeline to include Alzheimer's disease (AD) as a new indication for its lead investigational product, COYA 302. This decision is based on the drug's multimodal mechanism, which has shown promise in targeting complex immune pathways in neurodegenerative conditions.
COYA 302 is a combination biologic therapy that integrates the company's proprietary low-dose interleukin-2 (LD IL-2) with CTLA4-Ig, both aimed at enhancing the anti-inflammatory function of regulatory T cells (Tregs) and reducing pro-inflammatory cell activity. The expansion into AD follows previous announcements indicating the drug's potential applications for Amyotrophic Lateral Sclerosis (ALS), Frontotemporal Dementia (FTD), and Parkinson's Disease (PD).
The company is currently conducting a double-blind, placebo-controlled proof-of-concept study with LD IL-2 in AD patients at Houston Methodist Hospital. Top-line results from this study are expected in mid-2024. The study's primary focus is on safety endpoints, with a secondary measure being the change in Treg percentage among CD4 cells.
Coya's CEO, Dr. Howard Berman, expressed optimism about the drug's potential, stating that the traditional approach of targeting a single disease pathway may not be sufficient for complex neurodegenerative diseases. He highlighted the company's growing intellectual property portfolio and the potential for COYA 302 to offer sustainable benefits to patients across various indications.
In terms of financial outlook, Coya Therapeutics reported a cash runway of at least two years, bolstered by an initial $7.5M payment from a partnership with Dr. Reddy's Laboratories for COYA 302 in ALS. The company anticipates milestones in 2024 that could enhance shareholder value, including further data publication, IND filings for ALS and FTD, and topline data from the ongoing AD study.
COYA 302 is not yet approved by the FDA or any regulatory agency. However, the company remains committed to developing this 'Pipeline in a Product' as a potential treatment for the millions affected by neurodegenerative diseases in the U.S. This announcement is based on a press release statement from Coya Therapeutics.
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