An investigator has posted data on Coya Therapeutics’ COYA 301, linking the IL-2 asset to improvements in biomarkers and cognition on secondary and exploratory endpoints in a small Alzheimer’s disease trial. The biotech put the asset on the back burner last year but said the data boost its confidence in pursuing partnerships and studying drug combinations.
Coya sees IL-2 as a molecule that can boost the number and power of regulatory T cells (Tregs), leading it to study it as a single agent, COYA 301, and pair the cytokine with the recombinant fusion CTLA4 protein abatacept in COYA 302. The combination is intended to provide synergistic neuroprotection, with IL-2 triggering a rise in functional Tregs and abatacept-boosting anti-inflammatory macrophages.
Alireza Faridar, M.D., a neurologist at Houston Methodist Hospital, looked at (PDF) the IL-2 component of the combination in an investigator-initiated trial. The study randomized 38 people with mild to moderate Alzheimer’s to receive one of two regimens of IL-2 or placebo.
No patients had serious, treatment-related adverse events, causing the study to hit its primary endpoint. The secondary endpoints looked at whether IL-2 is having the desired biological effects. Assessments of efficacy were limited to exploratory endpoints.
Faridar saw the sustained expansion of Tregs throughout the period in which patients received IL-2. On the Treg endpoints, IL-2 performed best when given every four weeks, rather than every two weeks. The less frequent dosing regimen also looked better on the exploratory efficacy endpoints.
The four-week regimen “resulted in slight improvement of ADASCog Score, with stabilization or decreased rate of decline in key clinical scales.” Coya called the result a promising trend in stabilizing cognitive function and a clinically meaningful improvement in ADAS-Cog compared to placebo. The study also tracked an improvement in levels of a form of amyloid beta in the cerebrospinal fluid (CSF).
Coya said the weaker data on the more frequent regimen underscore “the importance of appropriate IL-2 dosing for maintaining Treg functionality and its associated effects on CSF biomarkers and cognitive outcomes.” The trial tracked a reduction in a marker of Treg functionality in the two-week cohort. Coya said the result may explain the weaker data and is likely to advance the four-week regimen.
The biotech is preparing to study COYA 302 in a phase 2 amyotrophic lateral sclerosis. The FDA told Coya in August to submit additional non-clinical toxicology and pharmacology data before starting the trial. Coya ended June with enough money to fund operations into 2026 and subsequently raised $10 million. The biotech recently promoted a dealmaker to the CEO role.