Regenera Announces Publication of RPh201 First-in-Human Phase 1 Study Data in Clinical Pharmacology in Drug Development Journal05/07/19
A First-in-Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers
Publication Highlights Encouraging Evidence of RPh201’s Safety and Tolerability in NAION Patients
Data Supportive of Company’s Ongoing Multicenter US-Based Phase 3 Trial
NESS-ZIONA, Israel, May 14, 2019 – 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, announced the publication of results from its a first-in-human Phase 1 randomized Single and Multiple Ascending Dose Study of RPh201 in healthy volunteers in Clinical Pharmacology in Drug Development Journal.
The clinical trial in the publication was a Phase 1, a single-center, randomized, placebo-controlled, double- masked study in healthy volunteers assessed the safety and tolerability of RPh201, and determined the highest tolerated dose. There were 2 parts: a single ascending dose (SAD) stage, followed by a multiple ascending dose (MAD) stage.
Three dosing arms were included in each stage (5 mg, 10 mg, and 20 mg). Safety data in the lower dosing arms were evaluated before higher doses were initiated. Eighteen participants were randomized in the SAD stage: 12 to RPh201 (4 at each dose) and 4 to placebo. Twenty-one participants were randomized in the MAD stage, of which 13 received RPh201.
Treatment of healthy human volunteers with doses of RPh201 from 5 to 20 mg, either as a single dose or as multiple doses administered twice weekly, was safe and well tolerated. The majority of the AEs considered to be related to the study/treatment were associated with general administration and injection site reactions. RPh201 was administered subcutaneously, a route that is frequently associated with localized injection site reactions.
Based on the data from this Phase 1 study and a Phase 2a randomized, placebo-control study in participants with previous NAION, a neurodegenerative disease resulting in vision loss, a Phase 3 clinical trial involving RPh201 was initiated and ongoing (NCT03547206).
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