ADDF invests $5m in Coya to support Phase 2 dementia trial

Company targets frontotemporal dementia after therapy to enhance regulatory T cell function demonstrates promising results in ALS patients.

US biotech Coya Therapeutics (Nasdaq: COYA) has announced a strategic investment from the Alzheimer’s Drug Discovery Foundation (ADDF). The Houston, Texas-based company, which focuses on enhancing regulatory T cell function to address neurodegenerative, autoimmune and metabolic diseases, revealed that the ADDF has purchased 603,136 shares of Coya’s common stock, amounting to a $5 million investment.

The ADDF is dedicated to accelerating the development of drugs to prevent, treat and cure Alzheimer’s disease and related dementias. The new investment is to support the ongoing clinical development of Coya’s lead therapeutic candidate, COYA 302, which is under evaluation for multiple neurodegenerative diseases. Specifically, the funds will be used towards a planned Phase 2 trial of COYA 302 in frontotemporal dementia (FTD).

COYA 302 aims to enhance regulatory T cell and reduce inflammation by using a low-dose combination of interleukin-2 (LD IL-2) and CTLA4-Ig (abatacept). The dual approach targets systemic and neuroinflammation and is being developed for subcutaneous administration to treat conditions including ALS, FTD, Parkinson’s disease and Alzheimer’s disease.

“Inflammation has emerged as a promising novel pathway for chronic neurological diseases like FTD,” said Dr Howard Fillit, Chief Science Officer of the ADDF. “A combination drug, like COYA 302, is an innovative approach being developed to suppress neuroinflammation by targeting multiple inflammatory pathways. Combination therapy will be integral to slowing – and eventually halting – cognitive decline for a disease as complex as FTD, and exploring combined therapeutic modalities is an important advancement in the development of future care regimens.”

In a previous proof-of-concept study at Houston Methodist Hospital, COYA 302 demonstrated safety and tolerability over a 48-week treatment period in ALS patients. The study showed promising results, including stable disease progression and enhanced regulatory T cell suppressive function.

Dr Howard Berman, CEO of Coya said that many neurodegenerative diseases share common disease pathways that are linked to “the complex interplay of the body’s immune system and dysfunctional anti-inflammatory regulatory Tregs.”

“Thus, the traditional ‘one disease – one target – one drug’ approach may be ineffective for such neurodegenerative diseases, which may at least partially explain why there are limited effective treatments for these conditions,” said Berman. “However, we believe the results thus far from studies involving COYA 302 indicate the potential to provide a sustained and lasting effect on these neurodegenerative diseases through the targeting of multiple immune pathways.”