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Article:
Corbus said the invitation to continue with the trial would be extended to those who were on the placebo.
Resunab was granted Orphan Drug Designation and Fast Track status by the FDA in 2015
Drug developer Corbus Pharmaceuticals Holdings, Inc (NASDAQ:CRBP) has been given the regulatory green light for an extension study of its candidate, Resunab, for systemic sclerosis.
The US Food and Drug Administration (FDA) has granted approval for a 12-month open-label extension study of the in progress Phase 2 clinical trial of Resunab.
An open-label study is one where the patients know what treatment they are receiving.
The goal of the extension study is to provide all subjects with the option of receiving Resunab following the completion of the 84-day treatment period, with a view to collecting long-term safety and efficacy data on Resunab, an orally taken drug that emulates chemical compounds that activate the same receptors as the active component of marijuana, which is known to relieve pain.
Corbus said the invitation to continue with the trial would be extended to those who were on the placebo.
The extra 12-months of safety and efficacy data would be invaluable to the clinical advancement of the drug, said Barbara White, chief medical officer of Corbus.
“There is a clear unmet need for effective therapy options for individuals living with systemic sclerosis,” said the principal investigator in the study, Robert Spiera of the Vasculitis and Scleroderma Program at the Hospital for Special Surgery, Weill Cornell Medical College in New York City.
“Since the launch of the study, individuals have been very receptive to participating, and we look forward to furthering our understanding of the long-term safety and efficacy of Resunab through this open-label extension study,” he added.
Source: Proactive Investors