Kenai Therapeutics Completes Enrollment of Phase 1b/2a Parkinson’s iPSC Trial
The iPSC-derived neural cell therapy takes its next step in potentially restoring dopaminergic neurons lost to the condition.
Key Points
- Kenai Therapeutics has completed enrollment in the Phase 1b/2a REPLACE trial of RNDP-001 for idiopathic Parkinson’s disease.
- RNDP-001 is an allogeneic (donor derived), off-the-shelf neuron replacement cell therapy designed to restore dopaminergic neurons lost in Parkinson’s disease.
- The open-label, multicenter study is evaluating safety, tolerability, and preliminary clinical activity, with initial observations expected later.
Kenai Therapeutics, a Boston-based biotech company, has completed enrollment in the REPLACE Phase 1b/2a clinical trial of RNDP-001, an investigational cell therapy for moderate to moderate-severe idiopathic Parkinson’s disease. The open-label, multicenter study is assessing safety, tolerability, and preliminary clinical activity in enrolled patients.
RNDP-001 is an off-the-shelf, allogeneic (donor derived) neuron replacement cell therapy derived from induced-pluripotent stem cells (iPSCs). The program is intended to restore dopaminergic neurons that are lost in Parkinson’s disease. Kenai said it expects to report initial safety, tolerability, and efficacy observations from the trial.
“Completing enrollment in the REPLACE trial is an important milestone for Kenai and a meaningful step in advancing our program for patients with Parkinson’s disease,” said Nick Manusos, Chief Executive Officer of Kenai Therapeutics. “We thank the patients, caregivers, investigators, and clinical site teams for their participation and support in making this achievement possible.”
“Existing therapies for iPD address symptoms but do not replace neurons lost to the disease,” said Howard Federoff, M.D., Ph.D., Scientific Co-Founder, Chief Medical Officer, and EVP of Corporate Medicine and Science. “RNDP-001 represents a different investigational approach intended to restore dopaminergic neurons and neural circuitry. REPLACE will provide early clinical data to evaluate that potential.”
RNDP-001 has received Fast Track designation from the FDA, and received funding support from the California Institute for Regenerative Medicine (CIRM).
Here’s a snapshot of its pipeline:
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