ReNeuron Group is an AIM listed biotechnology company developing allogeneic cell therapies. Their clinical data presentation at last month’s American Academy of Ophthalmology (AAO) meeting was met with some stock price weakness, whereas updates reported in February saw startling vision gains reported.
The first 12 patients in the Phase I study portion will now be followed for safety only. Two recently-dosed patients experienced some procedure-related vision loss. Overall, the results to date remain encouraging, while reminding us how early on the learning curve this technology is.
ReNeuron’s February announcement of the results of the first, three-patient cohort in its Phase I/IIa clinical study of the human retinal progenitor cell (hRPC) therapy for retinitis pigmentosa (RP) showed rapid and significant visual acuity gains. In March, it announced that the review of this data by the drug safety monitoring board had enabled in the next three-patient cohort in the Phase II part of the study to be dosed, and next in September the dosing of the final cohort was reported to be underway.
The second cohort comprised patients with a greater baseline visual acuity (i.e. less severe, or have better vision at baseline). The data on three of these less severe RP patients at the 90-day time point showed lower visual acuity gains than the first three patients dosed and in addition, two other new patients experienced some procedure-related vision loss.
With results on only 8 of 22 patients presented so far, the data from this study needs to mature further. Longer-term (180-days of follow-up) read-outs in the first 3 (most severe) patients dosed continue to be encouraging.