Coya Therapeutics has completed participant enrolment of an investigator-initiated, open-label trial evaluating low-dose IL-2 and CTLA4-Ig combination treatment in subjects with mild to moderate frontotemporal dementia (FTD).
The company, which is focused on developing biologics that improve regulatory T cell function, reached this milestone following encouraging interim data.
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Led by Dr Stanley Appel and Dr Alireza Faridar at the Houston Methodist Neurological Institute, the study secured financial support from the Peggy and Gary Edwards Endowment Fund and enrolled nine FTD subjects.
After the announcement of positive interim data from five participants in April 2025, researchers proceeded to enrol four more participants to finalise the intended cohort.
After a dosing and follow-up period of 22 weeks, study subjects were given CTLA4-Ig subcutaneously, followed by low-dose IL-2 every four weeks for five days.
According to protocol, the trial is advancing with no serious adverse events or discontinuations reported due to safety issues.
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By GlobalDataCoya plans to release study results following database lock and analysis. The trial is anticipated to conclude in the fourth quarter (Q4) of 2025 with topline results to follow.
Coya CMO Dr Fred Grossman said: “We are pleased to announce the completion of this important clinical milestone. FTD is a devastating neurodegenerative disease of high unmet need. We remain committed to developing an effective and safe treatment for this rare form of dementia.”
FTD encompasses a range of neurodegenerative disorders that are characterised by changes in behaviour and language, alongside a progressive deterioration in executive function. It is estimated to affect around 30,000 individuals in the US.
Clinical subtypes encompass behavioural-variant FTD and two language variants: semantic dementia and progressive non-fluent aphasia.
As a form of presenile dementia, it can manifest in younger individuals, typically between the ages of 45 and 64, with an average onset at 58 years and survival time of 7.5 years.
