ReNeuron Group Plc (LON:RENE) has received positive guidance from US regulators as it prepares to take its CTX cell therapy candidate for stroke victims into final-stage clinical trials.
Following “favourable feedback” from the Food & Drug Administration, the watchdog specifically recommended the company apply for a Special Protocol Assessment (SPA) for the phase III study.
WATCH: ReNeuron 'greatly encouraged' by US regulator feedback on CTX cell therapy trial
The special protocol, among other things, is designed to give preliminary FDA input into the clinical trial process, therefore reducing uncertainty and by extension shortening the timeline to market.
ReNeuron pointed out the SPA process “is exclusively reserved for studies considered potentially pivotal in support of product marketing label claims”.
Second application
The company is also applying for Regenerative Medicine Advanced Therapy (RMAT) designation for its CTX treatment, which is designed for people left disabled by stroke.
The benefits of RMAT clearance are similar to those of Breakthrough Therapy designation, including increased interactions with the FDA during development and eligibility for priority review and accelerated marketing approval.
Chief executive Olav Hellebø said he was “greatly encouraged” by the feedback received from the US regulator, “especially the recommendation that we seek a Special Protocol Assessment for the study”.
“We take this feedback as an endorsement of our proposed approach to this important clinical trial and further recognition of the very large unmet medical need represented by patients left with lasting disabilities following an ischaemic stroke," he added.
ReNeuron is working to finalise the data packages that will allow it to apply for both the SPA and RMAT authorisations along with the sign-off for the clinical trial, which is slated to commence early next year.