Coya Therapeutics has reported data from an academic clinical study of its investigational proprietary biologic, COYA 301, in Alzheimer’s disease (AD) patients.

The open-label, proof-of-concept clinical trial was designed for assessing the tolerability, safety, blood biomarkers, regulatory T cell (Treg) function, and preliminary efficacy of COYA 301 in eight mild-to-moderate AD patients.

It is claimed to be the first trial of its kind to assess low-dose IL-2 immunotherapy for AD treatment.

In the trial, the participants received treatment with COYA 301 for four consecutive months.

The academic study was conducted by Dr Stanley Appel and Dr Alireza Faridar at the Houston Methodist Research Institute in Houston, Texas.

COYA 301 is the company’s investigational low-dose interleukin-2 (IL-2) for subcutaneous administration.

It has been designed for enhancing Treg anti-inflammatory function in vivo to treat Frontotemporal Dementia (FTD), an orphan disease with a high unmet need.

The subcutaneous administration of COYA 301 allows patients to be dosed in their homes, which offers convenience and pharmacoeconomic advantages over the current products, which require administration in a hospital setting.

Coya Therapeutics stated that Treg dysfunction was identified as an important driver of neuroinflammation that is observed in AD as well as other neurodegenerative diseases and may contribute to the progression of the disease.

According to the company, AD affects approximately five million people in the US, and this number is estimated to nearly triple by 2060.