ReNeuron Group plc reported that patient dosing has now commenced in the US in the expanded Phase 2a clinical trial of hRPC cell therapy candidate in retinitis pigmentosa (RP) patients. The expanded study will enable the treatment of up to a further nine patients (beyond the ten Phase 2a patients already treated) at a higher dose level, under a revised protocol at clinical sites in both the US and the UK. RP is a group of hereditary diseases of the eye that lead to progressive loss of sight due to cells in the retina becoming damaged and eventually dying. The company has previously announced positive efficacy data from patients in this study at all time-points including, for the first patient treated, out to 18 months follow-up. As announced in the Company's preliminary results statement on 20 July 2020, The company expects to present further data from the expanded Phase 2a clinical trial during the next twelve months. The company expected this expanded Phase 2a study to generate sufficient data to enable the Company to seek regulatory approval in the second half of 2021 to commence a single pivotal clinical study with hRPC cell therapy candidate in RP. The pivotal study will be designed to demonstrate further the efficacy of this treatment and, assuming a successful outcome, to enable ReNeuron to seek marketing approvals for its hRPC cell therapy candidate in RP in selected major markets. This RP programme has been granted Orphan Drug Designation in both Europe and the US, as well as Fast Track designation from the FDA in the US. Orphan Drug Designation provides the potential for a significant period of market exclusivity once the therapy is approved in those territories. Fast Track designated products may also be eligible for accelerated approval and priority review programmes offered by the FDA.