Kenai Therapeutics Announces First Patient Dosed in Phase 1 REPLACE™ Clinical Trial of Neuron Replacement Cell Therapy RNDP-001 for Idiopathic Parkinson’s Disease
Fast Track designation granted by U.S. FDA
Initial safety, tolerability and brain imaging data from the trial are expected in 2026
Excerpt from the Press Release:
SAN DIEGO, Dec. 15, 2025 /PRNewswire/ — Kenai Therapeutics, a clinical-stage biotechnology company pioneering next generation approaches to cure neurological conditions, today announced that the first patient has been dosed in its Phase 1 REPLACE™ clinical trial of RNDP-001 for the treatment of moderate to moderate-severe idiopathic Parkinson’s disease. This milestone follows the clearance of Kenai’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration, allowing the company to initiate clinical evaluation of RNDP-001, an off-the-shelf, allogeneic neuron replacement cell therapy designed to restore motor function by replacing the dopamine-producing neurons lost to Parkinson’s disease. RNDP-001 has also been granted Fast Track designation by the U.S. FDA in recognition of the urgent need for new therapies in Parkinson’s disease. Fast Track designation is intended to accelerate development and review of RNDP-001.
“While most Parkinson’s disease treatments focus on symptom management, RNDP-001 aims to replace lost neurons, repair damaged neural circuits and restore motor function for patients with moderate to moderate-severe forms of the disease. By moving beyond symptom control to address the root cause of disease, our goal is to offer patients a future with improved motor function and better overall quality of life,” said Nick Manusos, Chief Executive Officer of Kenai Therapeutics. “This milestone marks an important step forward for Kenai and for families impacted by Parkinson’s.”
The Phase 1 REPLACE™ study is an open-label, multi-center trial evaluating the safety and tolerability of RNDP-001, as well as brain imaging evidence of cell survival and engraftment, in adult patients with moderate to moderate-severe idiopathic Parkinson’s disease, a condition with unknown cause.
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