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Pharma & Biotech

ReNeuron says phase IIa eye disease study "proceeding according to plan" as new group is dosed

Data from the clinical assessment will be presented later this year

ReNeuron PLC (LON:RENE) said it has completed dosing of the first group of three people in its phase IIa extension study of its human retinal progenitor cell therapy for degenerative eye disease.

This part of the trial will assess the responses of nine sufferers of retinitis pigmentosa – but at higher doses than the first ten subjects already treated. Data will be presented later this year.

ReNeuron said there would be a review of the short-term safety data from this first cohort before the next group is dosed.

The latest person taking part in the clinical assessment was treated at a new site - the prestigious Casey Eye Institute in Oregon.

In a statement, ReNeuron chief executive Olav Hellebø said: "We are extremely pleased to have completed dosing of the first subject cohort in the extended phase IIa clinical study with our hRPC cell therapy candidate in RP patients.

“We are excited that one of the subjects was treated at a new clinical site in the US and we hope to add further new clinical sites shortly. The study continues to proceed according to plan."

The company said it expects the phase IIa work to generate enough data to enable it to embark on a single pivotal clinical study, which is expected to take place in the second half of next year.

It will be designed to demonstrate further the safety and efficacy of this treatment and, assuming a successful outcome, enable ReNeuron to seek marketing approvals for its treatment.

Its human retinal progenitor cell programme has been granted orphan drug designation in both Europe and the US, and has fast track status in the US.

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