The first patient has been dosed in the phase 1/2a clinical trial of OpCT-001, the first induced pluripotent stem cell (iPSCs)-derived investigational cell therapy for primary photoreceptor diseases including retinitis pigmentosa and cone-rod dystrophy.
BlueRock Therapeutics’ OpCT-001 was granted fast-track designation by the US Food & Drug Administration early this year. The Clarico study, the first-in-human trial of OpCT-001, will involve up to 54 adults with primary photoreceptor disease and will focus on safety with a dose-escalation design, said the company.
The initiation of the Clarico trial represents a key milestone for the OpCT-001 programme, said Dr Amit Rakhit, BlueRock’s chief development and medical officer. “We believe OpCT-001 holds significant promise as a novel therapeutic approach for restoring vision in people living with primary photoreceptor diseases.”
