We are starting a Phase 3 study in 12 U.S. centers with approximately 234 participants. It will be a double-masked study for evaluating the efficacy and safety of RPh201 treatment in participants diagnosed with NAION. Participants will be administered twice-weekly doses subcutaneously of our lead drug candidate, RPh201, over six months to measure the impact on visual function.
Regenera will commence a Phase 2 study with up to 80 subjects in about five clinical centers in Canada. The six-month, double-blind Phase 2 study will evaluate the safety, tolerability, and clinical benefit of RPh201 in individuals with Alzheimer’s disease, with or without coexisting cerebrovascular disease.
Regenera is collaborating with Henry Ford Health System to investigate the therapeutic effects of RPh201 on stroke recovery in a rat model of embolic middle cerebral artery occlusion (MCAO). Assessments will be completed focusing on angiogenesis, neurogenesis, and neurological function up to four months after the initiation of treatment. Together with well-known key opinion leaders, we are planning and designing a Phase 2 clinical trial in post stroke patients.