Patient enrolment completed in Phase 2 aGvHD trial

December 15, 2025 | 15:04

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This milestone allows the study to proceed, evaluating a new treatment for acute graft versus host disease patients.

MELBOURNE, Australia, Dec. 15, 2025 /PRNewswire/ -- Cynata Therapeutics Limited (ASX: "CYP" or "Cynata"), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that patient enrolment has been completed in its Phase 2 clinical trial of CYP-001 in adults with newly diagnosed, high risk acute graft versus host disease (aGvHD).

A total of 65 participants have been enrolled in the trial across numerous clinical centres in the US, Europe and Australia. Each participant was randomised to receive either steroids plus CYP-001, or steroids plus placebo.

The trial involves a 100-day primary evaluation period, which is expected to conclude in March 2026, with results anticipated around June 2026. The primary endpoint is Overall Response Rate at Day 28.

Dr Kilian Kelly, Cynata's Chief Executive Officer and Managing Director, said: "We are delighted to complete patient enrolment in this trial, which has huge importance to Cynata, as well as to patients afflicted with aGvHD, an extremely debilitating and potentially life-threatening disorder. There remains a significant unmet need for safer and more effective treatments, given that existing treatments often fail to prevent poor outcomes, as well as potentially causing serious safety concerns. We are optimistic that the results of this trial will build on the very encouraging results we saw in Phase 1."

By PR Newswire

Cynata Therapeutics

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