March 2014: Regenera Pharma Ltd. initiated the Phase 2a study in patients with previous Ischemic Optic Neuropathy (NAION).21/03/14
Based on promising pre-clinical results and in order to demonstrate the clinical efficacy of the RPh201, the Company recently has been initiated the Phase IIa study in patients with ischemic optic neuropathy. The study will take place at Western Galilee Hospital, Nahariya, Israel and is expected to end in 24 months.
This is double-blind, placebo-controlled study, Phase IIa study in patients with chronic Traumatic Neuropathy or Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), will evaluate the safety and tolerability of multiple SC administration of RPh201.
About 20 patients diagnosed with optic nerve neuropathy for a maximum period of three years after the event, being at least 6 months without any treatment following the event and stable (no improvement of visual field and/or visual acuity) are expected to be enrolled into the study. The patients will receive twice-weekly subcutaneous doses of RPh201 or Placebo, in 1.5:1 drug to placebo ratio for up to 26 weeks and monitored for a follow-up period of an additional three months. During the study, patients will be assessed for any changes in Visual Acuity, Visual Field, Visual Evoked Potential and Optical coherence tomography.
For more information about the study, please visit ClinicalTrials.gov.
Initiation of this trial represents another important milestone in the clinical development of RPh201. Regenera is expecting to reinforce its encouraging pre-clinical efficacy results as well as the safety profile that was clearly demonstrated for this drug.