Regenera Pharma Information

At Regenera, we aspire to change the devastating inevitability of long-term damage to the central nervous system, bringing light to patients where there is darkness and despair today. Our lead drug candidate has the potential to restore neural function in a wide range of neurological and neurodegenerative disorders. Our dedicated team made up of highly experienced industry veterans is working tirelessly and meticulously to achieve this goal. Our novel drug RPh201 is an extract from a botanical source, mastic gum, that has been shown to stimulate the formation of new neurons and synapses. It is extracted, purified, formulated, and stabilized in a proprietary low-cost manufacturing process. NAION (Nonarteritic Anterior Ischemic Optic Neuropathy), is a stroke of the optic nerve that causes sudden visual impairment to the point of blindness. It is a leading cause of sudden optic nerve-related vision loss, predominantly in the Caucasian population over 50 years of age. The cause of NAION is unclear, but it is associated with diabetes, systemic hypertension, and ischemic heart disease. More than 200,000 people a year suffer from NAION. Prognosis for these patients is poor, with up to 50% having acuity of 20/200 (6/60) or less, with significant visual field loss and permanent visual impairment. There are no approved treatments for NAION. Until now. NAION 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. ALZHEIMER’S DISEASE 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. POST STROKE 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.