ReNeuron upbeat on latest stroke drug candidate trial findings
ReNeuron Group
3.38p
17:30 03/05/24
Cell-based therapeutics developer ReNeuron Group updated the market on Tuesday on its Phase II clinical trial ‘PISCES II’ of its CTX cell therapy candidate for stroke disability and, in addition, its global clinical and regulatory development strategy for the stroke programme.
FTSE AIM All-Share
795.26
08:05 20/05/24
Pharmaceuticals & Biotechnology
23,285.83
08:05 20/05/24
The AIM-traded company confirmed that the positive response rates in key measures reported at three months after treatment in the PISCES II clinical trial were sustained at 12 months after treatment.
PISCES II is a single arm, open-label study in patients living with significant disability resulting from ischaemic stroke.
ReNeuron announced positive initial data from the study in December last year, when all patients had been followed up for at least three months after treatment.
At 12 months post-treatment, the response rates seen in the key measures of disability and dependency were maintained, it said on Tuesday.
The primary efficacy measure of the PISCES II study - motor function using the ‘Action Research Arm Test’ - improved between three and 12 months post-treatment.
Importantly, the Modified Rankin Scale (mRS) response rate - a measure of disability and dependence - was maintained with seven out of 20 patients showing a “clinically relevant” improvement.
It was that measure of disability and dependence that was likely to be carried forward as a primary endpoint in future pivotal studies with CTX in that indication.
ReNeuron said the PISCES II study also demonstrated that the CTX treatment was “well tolerated” in both short and longer term follow-up.
Detailed safety and efficacy data from the study would be presented at a forthcoming medical conference, the board said.
“These positive long term results are highly encouraging, indicating that the CTX therapy has the potential to produce meaningful and sustained improvements in disability as well as motor function in disabled stroke patients,” ReNeuron’s board said in its statement.
“No therapeutic interventions are currently available to improve motor function and quality of life for disabled stroke patients, with physical rehabilitation measures being the current standard of care.”
The company added that it would, as planned, shortly submit an Investigational new drug application to the FDA to commence a randomised, placebo-controlled clinical trial in the US in disabled stroke patients.
It said that study would involve fewer patients than the study originally planned, with data expected to be available earlier in the second half of 2019.
ReNeuron added that it would continue its discussions with regulatory authorities worldwide, but anticipated that a further pivotal study would likely be required for global marketing approval of the therapy.
“We are delighted that the long term follow-up data from the PISCES II clinical trial has shown the potential of our CTX cell therapy candidate to permanently improve function in patients living with chronic consequences following stroke,” said chief executive Olav Hellebø.
“Further, the study we plan to commence early in 2018 will allow critical placebo-controlled data with CTX in stroke disability to be available earlier than originally planned.”