ReNeuron Reports Interim Results for Eight Patients with RP in Phase 2a Trial for Stem Cell Therapy
The Foundation funded earlier lab studies that made the clinical trial possible.
ReNeuron, a company developing stem-cell therapies for retinal diseases and other conditions, has announced evidence of efficacy from the Phase 2a clinical trial for its stem-cell therapy for people with retinitis pigmentosa (RP) and related conditions.
The company’s treatment is a subretinal injection of human retinal progenitors — cells which have almost fully developed into photoreceptors, the light-sensing retinal cells that make vision possible.
In a presentation at the American Academy of Ophthalmology in San Francisco on October 12, 2019, the company reported interim results for the eight Phase 2a patients who reached at least one month follow-up.
Pravin Dugel, MD, an investigator in the study, said there were no cell- or immune-related adverse events in the Phase 2a trial. Two of the eight patients had vision loss related to the surgical procedure.
From the Foundation’s perspective, any gain in vision, or even stabilization, is a major step forward for patients with RP as currently it is a condition where progressive loss of vision leads to blindness.
Visual acuity (VA) in the treated eyes of the remaining six Phase 2a patients improved on average by two to three lines on an eye chart at 90 days after treatment.
In his presentation, Dr. Dugel said that vision improvements were “very rapid and profound in some patients…slower in other patients.” He added that the study results will help with patient selection and surgical procedure standardization in the future.
"We're excited by the progress of ReNeuron's cell therapy. From the Foundation's perspective, any gain in vision, or even stabilization, is a major step forward for patients with RP as currently it is a condition where progressive loss of vision leads to blindness,” said Benjamin Yerxa, PhD, chief executive officer, Foundation Fighting Blindness.
The Foundation Fighting Blindness funded Michael Young, PhD, Massachusetts Eye and Ear, for pre-clinical and translational studies for the cells that helped make the ReNeuron trial possible.
To date, 22 patients have been treated in ReNeuron’s study: 12 patients in the Phase 1 segment of the study and 10 patients in the Phase 2a segment of the study.
The trial is being conducted at Massachusetts Eye and Ear and the Retinal Research Institute in Phoenix under the leadership of Dr. Dugel and Jason Comander, MD, PhD.