SAN DIEGO, July 7, 2026
Kenai Therapeutics has announced the successful completion of patient enrollment in the Phase 1b/2a REPLACE™ clinical trial evaluating RNDP-001, an investigational off-the-shelf allogeneic neuron replacement cell therapy for the treatment of moderate to moderate-severe idiopathic Parkinson’s disease (iPD). The milestone marks a significant advancement in the company’s mission to develop disease-modifying regenerative therapies capable of restoring neurological function rather than simply managing symptoms. The open-label, multicenter REPLACE™ trial is assessing the safety, tolerability, and preliminary clinical activity of RNDP-001, which is designed to replace the dopamine-producing neurons progressively lost in Parkinson’s disease. The company expects to report initial observations on safety, tolerability, and early efficacy as the study progresses, providing valuable clinical insights into the potential of neuron replacement therapy for one of the world’s fastest-growing neurodegenerative disorders. The investigational therapy has already received U.S. FDA Fast Track Designation, recognizing its potential to address the significant unmet medical need for innovative Parkinson’s disease treatments.
RNDP-001 Aims to Restore Lost Dopaminergic Neurons
Unlike currently available Parkinson’s disease therapies that primarily alleviate symptoms, RNDP-001 is being developed as an allogeneic neuron replacement cell therapy designed to restore dopaminergic neurons destroyed during disease progression. Built using induced pluripotent stem cell (iPSC) technology, the therapy is intended to rebuild damaged neural circuitry and potentially provide long-term functional improvement for patients living with idiopathic Parkinson’s disease. According to Nick Manusos, Chief Executive Officer of Kenai Therapeutics, completing enrollment in the REPLACE™ study represents an important milestone made possible through the participation of patients, caregivers, investigators, and clinical research teams.
Dr. Howard Federoff, Scientific Co-Founder and Chief Medical Officer, emphasized that while existing therapies improve symptoms, they do not replace the neurons lost during disease progression, making RNDP-001 a fundamentally different investigational approach with disease-modifying potential. The study will generate early clinical evidence evaluating whether neuronal restoration can improve outcomes beyond conventional symptomatic treatment.
Fast Track Status Strengthens Regenerative Medicine Program
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The REPLACE™ Phase 1b/2a trial has received support from the California Institute for Regenerative Medicine (CIRM), reflecting continued investment in innovative stem cell and regenerative medicine research. RNDP-001’s FDA Fast Track Designation provides opportunities for closer regulatory engagement, eligibility for accelerated development pathways, and potential priority review if future clinical evidence supports regulatory approval. Parkinson’s disease currently affects more than 10 million people worldwide and remains the second most common neurodegenerative disease, with available therapies unable to halt or reverse neuronal degeneration. Kenai Therapeutics believes its proprietary Nobel Prize-winning iPSC platform offers a scalable approach to producing cryopreserved, off-the-shelf neuron replacement therapies capable of addressing this significant unmet medical need.
The company’s exclusive manufacturing partnership with FUJIFILM Cellular Dynamics further supports scalable commercial production should development prove successful. Completion of enrollment in the REPLACE™ study represents an important milestone not only for Kenai Therapeutics but also for the broader field of regenerative neurology, advancing the clinical evaluation of cell therapies that aim to restore neurological function and potentially transform the treatment landscape for patients living with Parkinson’s disease. Initial clinical findings from the trial are expected to provide critical evidence supporting the future development of this promising regenerative medicine approach.
Source: Kenai Therapeutics press release
