Kenai Therapeutics Hits Enrollment Milestone in Parkinson’s Cell Trial
San Diego-based Kenai Therapeutics has finalized enrollment for its REPLACE Phase 1b/2a clinical trial, marking a pivotal moment in the testing of RNDP-001. This investigational cell therapy aims to address the root cause of idiopathic Parkinson’s disease by replacing lost dopaminergic neurons rather than merely managing symptoms.
The open-label, multi-center study is currently assessing the safety, tolerability, and early clinical activity of RNDP-001 in patients diagnosed with moderate to moderate-severe Parkinson’s. Unlike conventional treatments that focus on symptom control, this allogeneic, off-the-shelf therapy is designed to restore neural circuitry. CEO Nick Manusos noted that completing enrollment is a significant step toward advancing the program for those living with the progressive disorder.
Howard Federoff, the company’s Chief Medical Officer, emphasized that the trial serves as a critical test of the drug's potential to provide disease-modifying benefits. The FDA has already granted RNDP-001 Fast Track designation, a status intended to expedite the review of treatments for serious conditions. The research is supported by the California Institute for Regenerative Medicine, which provided funding through grants CLIN1-14300 and CLIN2-19068. While the therapy remains investigational and has not yet been approved by regulatory authorities, the company expects to report initial observations on patient safety and efficacy in the coming months.
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