January 08, 2026
2 min read
Key takeaways:
- Frontotemporal dementia is a rare neurodegenerative disorder that worsens over time.
- Coya Therapeutics is expected to release topline results from an FTD-related study in the future.
The FDA has accepted an investigational new drug application for an investigational and proprietary combination therapy to treat frontotemporal dementia, according to a release from the manufacturer.
“Frontotemporal dementia (FTD) is a devastating progressive neurodegenerative disorder worsening over time, leading to severe changes in behavioral, personality, language and memory functions,” Coya chief medical officer Fred Grossman, DO, FAPA, told Healio. “We are very pleased that the FDA has accepted Coya’s FTD [investigational new drug application] so that we can initiate the Coya 302 FTD trial.”
The investigational, combination therapeutic was developed to address the lack of treatment options for the rare, neurodegenerative condition.
Fred Grossman
Coya, a Houston-based biotechnology company said in the release that Coya 302 features a dual immunomodulatory mechanism of action that boosts the anti-inflammatory function of regulatory T cells and suppresses inflammation caused by activated monocytes and macrophages.
Coya 302, one of the novel disease-modifying therapeutics in which the Alzheimer’s Drug Discovery Foundation expressed interest in May 2024, comprises both proprietary low-dose interleukin-2 (LD IL-2) and CTLA-4 Ig. It is currently intended for subcutaneous administration in those with ALS and Parkinson’s disease, according to the company release.
FTD, whose average age of onset is 58 years and whose average survival time is 7.5 years, is a rare condition affecting approximately 60,000 Americans. It is also one of the most common forms of dementia that strikes individuals aged younger than 65 years. There are no currently available treatments.
Coya is currently conducting the ALSTARS clinical trial, a phase 2, randomized, multi-center, double-blind, placebo-controlled study, to evaluate the safety and efficacy of Coya 302 to address ALS.
The company also expects to release topline results from an investigator-initiated, open-label study evaluating LD IL-2 and CTLA4-Ig in patients with mild to moderate FTD in the near future.
“The FDA’s acceptance of the IND application for Coya 302 is an exciting and promising step forward in the development of new therapies for patients with frontotemporal dementia (FTD), a disease area that has been historically challenging to treat with limited therapeutic options,” Howard Fillit, MD, cofounder and chief science officer, Alzheimer’s Drug Discovery Foundation, told Healio.
“Inflammation is a key underlying driver of disease progression in FTD, and by targeting multiple inflammatory pathways through this innovative combination approach, Coya 302 has the potential to more effectively address the complex biology of the disease and meaningfully impact patients,” he said.
For more information:
Fred Grossman, DO, FAPA, can be reached at neurology@healio.com. Howard Fillit, MD, can be reached at neurology@healio.com.
Sources/Disclosures
Source:
Disclosures:
Grossman is employed by Coya Therapeutics. Fillit is employed by the Alzheimer’s Drug Discovery Foundation.
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