ReNeuron’s hRPC stem cell therapy candidate has shown a meaningful clinical effect in patients with retinitis pigmentosa at 12 months, according to a press release.
Patients in a phase 2a segment of an ongoing phase 1/2 study who had a successful surgical procedure experienced a mean gain in visual acuity of 14.3 letters in the treated eye compared with 7 letters in the untreated eye at 12 months. Previous data showed a mean improvement of 12 letters at 9 months compared with –1 letter in the untreated eye.
“We remain greatly encouraged by the data from the phase 1/2a clinical study of our hRPC cell therapy candidate in patients with RP. The longer-term follow-up data are particularly noteworthy, demonstrating that the therapy appears to maintain its beneficial effects out to at least 1 year post-treatment,” ReNeuron CEO Olav Hellebø said in the release.
ReNeuron has submitted a protocol amendment to the FDA to expand the study to include another nine patients and has submitted an application to the Medicines and Healthcare Products Regulatory Agency to open the trial to one site in the United Kingdom.