The developer of cell-based therapeutics, ReNeuron Group (RENE) , said that its trial for patients with the degenerative eye disease, retinitis pigmentosa , had seen positive long-term data over the past year.

ReNeuron’s hRPC stem cell therapy study has shown patients with the disease to have sustained clinically relevant improvements in visual acuity, this morning’s statement outlined.

Progress from the study follows the company’s previous announcement in October 2019 which presented promising data from the hRPC trial, and the study has since continued to show a ‘meaningful’ clinical effect.

Those receiving the hRPC cells saw an improvement in visual acuity, peaking at a 28.7 letter improvement at six months post treatment, whilst those who received no treatment saw a marginal deterioration in eyesight.

"We remain greatly encouraged by the data from the Phase 1/2a clinical study of our hRPC cell therapy candidate in patients with RP,” said Olav Hellebø, Chief Executive Officer of ReNeuron Group.

Shares in ReNeuron Group were trading 3.51% higher at 147.5p during Monday trading.

He added, “The longer-term follow-up data are particularly noteworthy, demonstrating that the therapy appears to maintain its beneficial effects out to at least one-year post-treatment."

Meanwhile, the company said they had submitted a request of regulatory approval to the US FDA to add a further nine patients to the Phase 1/2a study.

ReNeuron expects to present further data from the expanded Phase 1/2a study during 2020 and said that it would allow it to seek approval for a pivotal study in the first half of 2021.

The group’s RP programme has been granted Orphan Drug Designation in both Europe and the US which will usher in a significant period of market exclusivity following the approval of the therapy in those territories the statement highlighted.

In addition, ReNeuron's secured fast track designation from the FDA in the US will provide eligibility for accelerated approval and priority review process by the regulatory body.

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