RNDP-001 / Kenai Therap - LARVOL DELTA

A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=12 | Active, not recruiting | Sponsor: Kenai Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease • Transplantation

Kenai Therapeutics Announces Completion of Enrollment in Phase 1b/2a REPLACE Trial of RNDP-001 in Idiopathic Parkinson's Disease (PRNewswire) - "The open label, multi center REPLACE study is assessing safety, tolerability, and preliminary clinical activity of RNDP-001 in the enrolled patient population. The company looks forward to reporting initial safety, tolerability, and efficacy observations from the trial."

Enrollment closed • Parkinson's Disease

Kenai Therapeutics Announces First Patient Dosed in Phase 1 REPLACE Clinical Trial of Neuron Replacement Cell Therapy RNDP-001 for Idiopathic Parkinson’s Disease (PRNewswire) - "RNDP-001 has also been granted Fast Track designation by the U.S. FDA in recognition of the urgent need for new therapies in Parkinson's disease....Initial safety, tolerability and brain imaging data from all 12 patients are expected in 2026."

Fast track • P1 data • Trial status • Parkinson's Disease

A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=12 | Recruiting | Sponsor: Kenai Therapeutics

New P1/2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease • Transplantation

Ryne Biotechnology Awarded $4 Million from the California Institute for Regenerative Medicine (Businesswire) - "Ryne Biotechnology, Inc...today announced that the California Institute for Regenerative Medicine (CIRM) has awarded the company a $4 million Clinical Stage Research Program (CLIN1) grant. This funding will enable the company to advance its lead candidate RNDP-001, an iPSC-derived dopamine neuron progenitor for the treatment of both inherited and idiopathic forms of Parkinson’s disease, through submission of an Investigational New Drug (IND) application within the next 12 months. RNDP-001 has completed preclinical efficacy and safety studies. This CIRM award will allow Ryne Bio to finalize its IND-package including the production of GMP-grade materials to enable the evaluation of RNDP-001 in Phase 1 clinical trials for both inherited and idiopathic forms of Parkinson’s disease."

Financing • IND • CNS Disorders • Parkinson's Disease