Regenera Announces Publication of RPh201 Phase 2a Study Data for the Treatment of NAION in the Journal of Neuro-Ophthalmology
Publication Highlights Encouraging Evidence of RPh201’s Safety and Efficacy in NAION Patients
Data Supportive of Company’s Ongoing Multicenter US-Based Phase 3 Trial
NESS-ZIONA, Israel, May 14, 2019 (GLOBE NEWSWIRE) -- Regenera Pharma, a clinical-stage pharmaceutical company focused on the development of treatments to restore neural function in a wide range of neurological and neurodegenerative disorders, today announced the publication of results from its Phase 2a clinical trial of RPh201 in patients with previous nonarteritic anterior ischemic optic neuropathy (NAION) in the Journal of Neuro-Ophthalmology.
“At Regenera, we are committed to developing RPh201 as a promising new candidate to help patients regain function that is lost after CNS damage,” said Jordan Rubinson, Chief Executive Officer of Regenera. “The peer-reviewed publication of our Phase 2a study is an important milestone in the development of RPh201 as a potential treatment for NAION. We are encouraged by this early data and are hopeful that RPh201 will provide NAION patients with a desperately needed treatment option. Having recently received Fast Track designation from the FDA, we remain focused on completing our ongoing Phase 3 study in patients with previous NAION at 12 sites in the U.S. and look forward to reporting top-line data in Q2 2020.”
The clinical trial in the publication was a Phase 2a, prospective, single-center, double-blind, placebo-controlled trial conducted at the Western Galilee Hospital in Nahariya, Israel. The study enrolled 20 participants with previous NAION who were randomized at a ratio of 1.5:1 (RPh201:placebo), and was not powered for statistical significance. Study highlights include:
- RPh201 was generally safe and well tolerated, and the majority of adverse events were mild in severity, with injection site pain and pruritus most common
- Reported serious adverse events (SAEs) were deemed unrelated to the study procedure and treatment
- Post-hoc analysis data utilizing a modified baseline to correct for training effects demonstrated a trend toward improvement in visual acuity, with 36% of patients on RPh201 treatment improving by ³ 3 lines in best-corrected ETDRS visual acuity after 26 weeks of treatment compared to 12% of patients on placebo (P=0.26).
- Post-hoc analysis including only patients with on-chart best-corrected visual acuity (BCVA) demonstrated that 29% of patients treated with RPh201 showed an improvement of ³ 3 lines in best-corrected ETDRS visual acuity after 26 weeks of treatment, compared to 0% of patients on placebo (P=0.19).
Leonard Levin, M.D., Ph.D., Professor of Ophthalmology & Visual Sciences and Neurology & Neurosurgery at McGill University, and the study’s corresponding author said, “NAION is the leading cause of acute optic-nerve-related vision loss in the middle-aged and elderly, with most patients showing little to no improvement over time after the initial event. The results from the published Phase 2a are encouraging. Given that there are presently no approved treatments for NAION, it would be a major achievement if the current Phase 3 clinical trial of RPh201 brought clinically meaningful improvement in vision to affected patients.”
Nonarteritic anterior ischemic optic neuropathy (NAION) is a stroke of the optic nerve and is the leading cause of acute optic nerve-related vision loss in the older population. The cause of NAION is unknown, but there are associations with diabetes, systemic hypertension and ischemic heart disease. More than 200,000 patients in the U.S. develop NAION annually, but there are no approved treatments. The prognosis is poor, with a significant proportion of patients having visual acuity of 20/200 or worse, along with significant visual field loss and permanent visual impairment.
About Regenera Pharma
Regenera is a clinical-stage biopharmaceutical company focused on developing novel drugs for neurological and neurodegenerative disorders. The company's lead product, RPh201, is a well-defined extract from gum mastic which is purified, formulated, and stabilized using a proprietary process, with regenerative and functional recovery benefits observed in preclinical and clinical studies. The company intends to use its drug candidate to offer treatments for a range of neurological and neurodegenerative disorders.
For more information, visit https://www.regenerapharma.com
Jordan Rubinson, MS, MBA
CEO, Regenera Pharma
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