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Coya Therapeutics' Low-Dose IL-2 Shows Promise in Phase 2 Alzheimer's Trial

• Coya Therapeutics announced results from a Phase 2 trial of low-dose interleukin-2 (LD IL-2) in mild to moderate Alzheimer's Disease (AD). • The investigator-initiated, placebo-controlled study was funded by organizations including the Alzheimer's Association and the Gates Foundation. • Clinical results were presented at the 17th Clinical Trials on Alzheimer’s Disease Conference (CTAD) in Madrid, Spain. • Coya Therapeutics is developing biologics to enhance regulatory T cell (Treg) function for treating systemic and neuroinflammation.

Coya Therapeutics, Inc. has announced the results of an investigator-initiated Phase 2 clinical trial evaluating low-dose interleukin-2 (LD IL-2) in patients with mild to moderate Alzheimer's Disease (AD). The results were presented at the 17th Clinical Trials on Alzheimer’s Disease Conference (CTAD) in Madrid, Spain.
The Phase 2 study, led by Dr. Alireza Faridar and Dr. Stanley Appel from the Houston Methodist Research Institute, was supported by funding from the Alzheimer's Association, the Gates Foundation, and the National Institute on Aging, with additional support from Coya Therapeutics.

Study Details and Coya's Strategy

Dr. Faridar presented a summary of the clinical results at the conference. Arun Swaminathan, Ph.D., Coya’s Chief Business Officer and incoming Chief Executive Officer, discussed the company’s strategy following the data release. The trial was placebo-controlled and aimed to assess the efficacy and safety of LD IL-2 in slowing the progression of Alzheimer's disease.

About Alzheimer's Disease

Alzheimer’s disease is the most common cause of dementia, accounting for up to 80% of dementia cases. It affects an estimated 5.7 million Americans. The incidence of Alzheimer’s increases with age, doubling every 5 years after age 65. It is a progressive disease where symptoms worsen over time, eventually leading to a loss of ability to carry on conversations and respond to the environment. Alzheimer’s is the sixth leading cause of death among all adults and the fifth leading cause for those aged 65 or older.

About COYA 301

COYA 301 is Coya's proprietary investigational low-dose interleukin-2 (IL-2) intended to enhance the anti-inflammatory function of regulatory T cells (Tregs). It is designed for subcutaneous administration. COYA 301 is an investigational product not yet approved by the FDA or any other regulatory agency.

Coya Therapeutics Focus

Coya Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments that leverage the biology and therapeutic potential of regulatory T cells (Tregs) to target systemic inflammation and neuroinflammation. The company's pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.
COYA 302, the company’s lead biologic investigational product, is a combination of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration. It is being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease. This multi-targeted approach enhances the number and anti-inflammatory function of Tregs and simultaneously lowers the expression of activated microglia and the secretion of pro-inflammatory mediators.
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Reference News

[1]
Coya Therapeutics Announces Conference Call to Report Results from an Investigator ... - BioSpace
biospace.com · Oct 28, 2024

Coya Therapeutics to discuss Phase 2 trial results of LD IL-2 in Alzheimer’s patients on Oct 29, 2024, at 8am ET, with a...

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