The ongoing phase I/II trial of ReNeuron Group Plc’s (LON:RENE) human retinal progenitor cell (hRPC) therapy has been given the green light by regulators to move into the phase II part of the study.
The hRPC therapy candidate is being trialled in patients with retinitis pigmentosa – a rare degenerative eye disease which can lead to blindness.
READ: ReNeuron making good progress with all of its key therapeutic programmes
The Data Safety Monitoring board gave its approval following short-term data from the nine patients taking part in the study, which indicated the therapy was safe and well-tolerated at the three doses tested.
ReNeuron has been hard at work developing a new formulation of hRPC recently which can be cryopreserved (frozen), extending its shelf life and allowing it to be shipped anywhere around the globe.
Cryopreserved formulation to be used in phase II trial
The final high-dose cohort patients in the phase I part of the study was treated with this new formulation, and the company expects to this version in the phase II element of the study.
This part of the trial will recruit six patients whose diseases haven’t progressed as much as those in the phase I element.
Readouts from the phase II trial are expected in the second half of next year, with efficacy data from a subsequent, larger phase IIb study due in 2020.
ReNeuron confirmed once again that an application will also be filed later this year to test the same hRPC therapy in a phase II trial in cone-rod dystrophy patients, and it hopes to have both phase II trials (RP and CRD) running concurrently.
‘High commercial potential’
"We are delighted that the Data Safety Monitoring Board has given its approval to progress our ongoing clinical trial in retinitis pigmentosa into its Phase II element,” said chief executive Olav Hellebø.
“Our hRPC cell therapy candidate offers the potential for an entirely new therapeutic option for patients suffering from diseases of the retina such as retinitis pigmentosa and cone-rod dystrophy, and represents a therapeutic platform technology with high commercial potential for ReNeuron.”
Shares rose 7.3% to 2.05p at the opening bell on Wednesday.
