Coya Therapeutics’ plan to treat frontotemporal dementia (FTD) by boosting the function of regulatory T cells (Tregs) is unraveling. Months after putting FTD at the heart of its IPO pitch, the biotech has decided it would be “premature” to continue to study its low-dose formulation of IL-2 in the indication.
When Coya went public late last year, it put advancing COYA 301 in FTD at the top of a list of the key elements of its strategy. At that time, the biotech planned to start a phase 1 trial in the indication in the first half of 2023 and have interim data before the year was out. The timeline slipped over the next few months, but, as of last month, Coya still planned (PDF) to start the trial this year and deliver interim data in 2024.
Now, Coya is pulling back from FTD. In a letter to shareholders explaining the move, CEO Howard Berman, Ph.D., outlined recent data in Alzheimer’s disease before adding “with all this said, we now believe it is premature to continue to study COYA 301 in frontotemporal dementia.”
FTD is absent from the indications listed on Coya’s pipeline (PDF), as are the earlier references to plans to start a clinical trial in the disease. The upcoming milestones for COYA 301 are limited to the publication of phase 1 data in a peer-reviewed journal, which is scheduled for this year, and the release of top-line data from an investigator-initiated phase 2 study in 2024.
The phase 2 trial, which is funded by the Gates Foundation and the Alzheimer’s Association, is enrolling up to 46 patients with mild to moderate Alzheimer’s to assess the effect of low-dose IL-2 on Treg function, blood biomarkers, cognitive performance and other endpoints. Coya plans to use the results to inform the design of a larger study.
While waiting on the midphase data, Coya will advance its other lead candidate, COYA 302. The prospect combines low-dose IL-2 and a CTLA4-Ig fusion protein in an attempt to both boost Treg function and downregulate effector T cells. Coya aims to start a phase 2 trial in amyotrophic lateral sclerosis next year.