GenSight Biologics announced that the independent Data Safety Monitoring Board (DSMB) completed its second planned safety review of the ongoing PIONEER phase 1/2 clinical trial of GS030, GenSightâ€™s novel product combining gene therapy and optogenetics for the treatment of retinitis pigmentosa (RP). The DSMB confirmed the absence of any safety issues for the second cohort of three subjects, who each received a single intravitreal injection of 1.5e11 vg (viral genomes) and used a wearable optronic visual stimulation device after the injection. The DSMB recommended moving forward as planned without any modification in the protocol and recruiting the third cohort of three subjects who are to receive the maximal dose of 5e11 vg.
â€śWe are pleased to be able to move forward with our second program GS030, which has now treated 6 patients. We look forward to confirming the safety of GS030 at the highest dose and to demonstrate efficacy by showing signs of functional vision recovery in advanced stage RP patients,â€ť Magali Taiel, MD, Chief Medical Officer of GenSight Biologics, said in a company news release.
The use of corticosteroids pre- and post-gene therapy injection, performed as part of the protocol to prevent and minimize inflammatory response, could potentially expose new patients to a higher risk of COVID-19 infection. Thus, to protect the safety of patients in the current COVID-19 situation, the company and investigators have together decided to delay recruiting new patients into the third cohort until the public health situation has improved. As RP is a chronic disease, it does not require urgent treatment. In the interim, the six patients treated in the first two cohorts are being remotely monitored for safety aspects by investigators.
GenSight expects to complete enrollment in the second half of 2020. In the context of COVID-19, this will have to be more precisely assessed as soon as possible. Early findings from the first two cohorts may be available in the course of 2020.