Updated Stifel reasearch14 Oct 2019 13:25
Don't think this says anything we don't know but :
Summary
ReNeuron has presented more detailed efficacy and safety data from the Phase I/IIa clinical trial of its hRPC stem cell therapy in retinitis pigmentosa (RP). The data continue to show a dramatic and sustained improvement in visual acuity for the first three patients treated, with a lower but gradually improving response from the next three evaluable patients. From a safety perspective, the data show a good overall safety profile, with no immune or cell-related adverse events reported, while the two cases of surgically related adverse events are consistent with those expected for sub-retinal injection procedures, and may be mitigated in the future with technique improvements. We continue to believe the hRPCs are delivering clinically meaningful improvements in vision, a measure of efficacy that gene therapy approaches for RP have thus far struggled to generate. We therefore believe the results fully support further clinical development of hRPCs, and ReNeuron's EV of approximately £35m is far too low and fails to reflect adequately the value being generated by the programme. Reiterate Buy.
Key Points
More detailed efficacy data at AAO. ReNeuron released further detailed clinical data at the recent American Academy of Ophthalmology Annual Meeting (AAO) in San Francisco. Pravin Dugel MD, an investigator in the ongoing Phase I/IIa study, made the presentation at the conference, which continued to show dramatic gains in visual acuity from the first three patients treated in the Phase IIa efficacy segment of the study, with an average +28.7 letter gain (range +22 to +38) after 6 months. For the next set of evaluable patients (with better residual retinal activity and acuity at baseline), no meaningful improvement was observed after 2 months (average +3 letters), but appeared to show more of a benefit after 3 months (average +8 letters). Excluding the two subjects with injection-related vision loss, the average improvement was +17.8 letters for all six evaluable patients after 3 months: