ADDF invests $5 million with Coya Therapeutics to develop, advance Alzheimer’s drugs
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The Alzheimer’s Drug Discovery Foundation has invested $5 million in Coya Therapeutics to help accelerate development and advance drugs to prevent, treat and cure Alzheimer’s disease and related dementias.
According to a company release, Coya’s lead therapeutic candidate, COYA 302, is being evaluated in multiple neurodegenerative diseases, including frontotemporal dementia (FTD). Funds from the ADDF are intended for a planned phase 2 clinical trial of the investigational, proprietary biologic combination therapy for those with FTD.
“We are grateful that a world-renowned organization like the ADDF has chosen to support our corporate mission as well as the clinical development of COYA 302 through this equity investment,” Coya CEO Howard Berman, PhD, said in the release. “We look forward to working with the ADDF to potentially bring a new treatment paradigm to these patients.”
COYA 302’s dual immunomodulatory mechanism of action aims to enhance the anti-inflammatory function of regulatory T cells (Tregs) as well as to suppress inflammation caused by activated monocytes and macrophages, according to the release.
The novel therapeutic, which is comprised of proprietary low dose interleukin-2 (LD IL-2) and CTLA4-Ig (abatacept), is being developed for subcutaneous administration for those diagnosed with amyotrophic lateral sclerosis, FTD, Alzheimer’s and Parkinson’s disease.
In February 2023, Coya announced results from a proof-of-concept, open-label clinical study evaluating commercially available LD IL-2 and CTLA4-Ig in a small cohort of patients with ALS conducted at the Houston Methodist Hospital. Participants received treatment for 48 consecutive weeks and were evaluated for safety and tolerability, Treg function, serum biomarkers of oxidative stress and inflammation as well as clinical functioning as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score.
According to data cited in the release, ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) differed only slightly compared with baseline score (33.5 ±5.9), suggesting a halt in disease progression over the 48-week treatment period. The drug was reported to be well-tolerated, with the most common adverse event being mild injection-site reactions. No participants chose to discontinue, and no other serious adverse events or deaths were reported.
“Inflammation has emerged as a promising novel pathway for chronic neurological diseases like [frontotemporal dementia]. A combination drug, like COYA 302, is an innovative approach being developed to suppress neuroinflammation by targeting multiple inflammatory pathways,” Howard Fillit, MD, co-founder and chief science officer of the ADDF, said in the release. “Combination therapy will be integral to slowing — and eventually halting — cognitive decline for a disease as complex.”