ReNeuron Group PLC (LON:RENE) has received regulatory approvals in the US and UK to expand its phase IIa stem cell studies in people with the degenerative eye disease retinitis pigmentosa.
In the same announcement, investors were told the company would focus its in-house activities on the retinal disease programme, while also developing its exosome-based technology.
This, ReNeuron chief executive Olav Hellebø said in the statement, provided the company “with significant near-term opportunities to deliver value-enhancing data and commercial partnerships”.
In a wide-ranging update, the company said patient recruitment to its PISCES III phase IIb study of CTX cells in stroke disability will be suspended for the foreseeable future after an initial temporary halt due to the global coronavirus (COVID-19) pandemic.
Clinical trial sites will be kept open and patients already treated will be followed up, ReNeuron added.
The potential treatment will be made available for licensing in stroke disability outside China, it added, following the release of positive data.
ReNeuron’s licensing deal with Fosun Pharma will ensure the stroke treatment’s continued development in the People’s Republic. Clinical trial applications there have recently been filed.
The extension of the in retinitis pigmentosa research, meanwhile, will see nine further patients in the US receive higher doses of the hRPC stem cell therapy.
In the UK, the study will be opened to the Oxford Eye Hospital, with Professor Robert MacLaren, a world-renowned leader in the treatment of retinal diseases, as principal investigator.
ReNeuron said it will start treating patients in the two countries “shortly” subject to a continued easing of lockdown restrictions.
Further updates from the expanded phase IIa trial will be presented during the next twelve months.
And ReNeuron said it expects to have sufficient data to enable it to seek approval in the second half of next year to begin a single pivotal clinical study with its hRPC cell therapy in people with the eye disease.
"We are delighted to have received regulatory approvals in both the US and the UK to pursue our expanded phase IIa study with our hRPC cell therapy candidate in retinitis pigmentosa,” said CEO Hellebø.
“We look forward to recruiting additional patients into the study shortly, subject to continuing easing of COVID-19 restrictions in these territories. Focusing our in-house activities on our retinal disease and exosome-based programmes provides the company with significant near-term opportunities to deliver value-enhancing data and commercial partnerships ."