Kenai Therapeutics said it has dosed the first patient in its Phase 1 REPLACE™ clinical trial evaluating RNDP-001, a novel off-the-shelf, allogeneic neuron replacement cell therapy for adults with moderate to moderate-severe idiopathic Parkinson’s disease.
The milestone follows clearance of the company’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration, allowing the open-label, multi-center study to begin enrolling subjects. The trial will assess the safety, tolerability and brain imaging evidence of cell survival and engraftment after targeted delivery of RNDP-001 into affected brain regions.
Initial safety, tolerability and imaging data from the study—which plans to enroll up to 12 patients—are expected in 2026. RNDP-001 has also received Fast Track designation from the FDA, intended to help accelerate its development and review given the unmet medical need in Parkinson’s disease. Kenai describes RNDP-001 as a therapy designed to replace the dopamine-producing neurons lost in the disease with the goal of restoring motor function rather than solely managing symptoms.
The treatment is derived from a donor-derived, cryopreserved induced pluripotent stem cell (iPSC) platform and is delivered via a precision neurosurgical procedure into targeted brain areas.
