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.
In section Releases
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.
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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