Bayer AG and its subsidiary BlueRock Therapeutics announced that the first patient has been dosed in the CLARICO clinical trial. This marks the start of a first-in-human study of OpCT-001, an investigational cell therapy derived from induced pluripotent stem cells (iPSCs) for primary photoreceptor diseases.
Inherited retinal diseases like retinitis pigmentosa and cone-rod dystrophy can lead to irreversible vision loss in children and adults. OpCT-001 is designed to restore vision by replacing damaged photoreceptor cells in the retina.
CLARICO is a phase 1/2a study that will enroll up to 54 participants. The first phase will evaluate safety through a dose-escalation design, while the second will assess additional safety and potential effects on vision and retinal cell engraftment. The trial is being conducted across multiple sites and includes masking procedures to maintain trial integrity. RP