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COYA 302 for Frontotemporal Dementia (FTD)

COYA 302
Phase 2 (Planned)
Interested in Participating?
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Trial Summary

Study Purpose

  • Coya Therapeutics is advancing COYA 302 for the treatment of Frontotemporal Dementia (FTD).
  • In January 2026, the U.S.
  • FDA accepted our Investigational New Drug (IND) application for COYA 302 in FTD, marking a significant milestone in our development program.
  • An investigator-initiated study of low-dose IL-2 and CTLA4-Ig (the components of COYA 302) demonstrated Treg enhancement and cognitive stability in FTD patients, with nine individuals clinically diagnosed with FTD enrolled in the study.

Study Drug Information

  • COYA 302 is an investigational biologic combination therapy comprising low dose interleukin-2 (LD IL-2) and CTLA-4 Ig (abatacept).
  • This combination is designed with a dual immunomodulatory mechanism of action to enhance the anti-inflammatory function of regulatory T cells (Tregs) while suppressing inflammation from activated immune cells.
  • The therapy aims to address neuroinflammation, which plays a key role in FTD progression, by boosting the body's natural immune regulatory mechanisms.
Trial Phase

Phase 2 (Planned)

Duration

To be announced

Age Range

To be determined

Study Design

Clinical trial design pending - expected to include open-label and controlled phases

Who This Trial Is For

Inclusion Criteria

  • Diagnosis of behavioral variant FTD or primary progressive aphasia
  • Clinical Dementia Rating (CDR) score within specified range
  • Reliable caregiver who can accompany participant to study visits
  • Stable medications for at least 30 days prior to enrollment
  • Ability to comply with study procedures

Exclusion Criteria

  • Other causes of dementia (e.g., Alzheimer's disease, vascular dementia)
  • Active psychiatric illness that could interfere with study participation
  • Use of immunosuppressive therapies
  • Prior exposure to IL-2 or abatacept within specified timeframes
  • Significant medical illness affecting participation

Please note: Final eligibility criteria will be established when the clinical trial opens for enrollment. The study team will review your medical history to determine eligibility. Please register your interest to receive updates when enrollment begins.

What Participation Involves

Visit Schedule

  • Visit schedule will be announced when the trial opens for enrollment.
  • Participants should expect regular study visits for assessments, treatment administration, and follow-up.

Time Commitment

  • Time commitment details will be provided when the trial protocol is finalized.
  • FTD trials typically require caregiver involvement at each visit.

Procedures and Tests

Neurological and cognitive assessments
Blood tests for safety and biomarker analysis
Brain imaging studies (MRI)
Caregiver assessments and questionnaires
Quality of life evaluations
Study drug administration via subcutaneous injection

Compensation

Compensation for time and travel expenses may be available. Details will be provided when enrollment opens.

Trial Sites

1 locations across the USA

Contact a site to learn more

Coya Therapeutics - Trial Coordination

Houston, TX, USA

Additional Resources