California-based, late-preclinical stage pharmaceutical company, Bionure, Inc,. has just announced it has signed a Sponsored Research Agreement with the National Multiple Sclerosis Society, thanks to Fast Forward, a division of the Society dedicated to commercial research and development for novel solutions for multiple sclerosis (MS). According to the contract between Bionure and Fast Forward, the latter will be funding Bionure for late pre-clinical testing of BN201 — a first-in-class, neuroprotective agent.
“We are excited to collaborate with the National MS Society towards accelerating BN201 into clinical trials for AON,” said Mr. Albert G. Zamora, Bionure’s Chief Executive Officer. “Fast Forward’s support provides an independent scientific validation for Bionure’s BN201 potential to treat AON and MS through an innovative approach and will allow Bionure to file the IND by Q2 of 2015.”
If successful, the preclinical results will enable Bionure to file for an Investigational New Drug application with the US Food and Drug Administration to validate a subsequent Phase I clinical trial in Acute Optic Neuritis (AON), a condition known to be one of the first signs of multiple sclerosis. BN201 was previously given an orphan drug designation by the FDA, as it has also shown the ability to drive remyelination by stimulating OPCs to mature into oligodendrocytes. Researchers at Bionure are looking to target MS during its earliest stages to greatly improve disease outcome and delay disabilities as much as possible.
“The National MS Society is committed to helping people with MS live their best lives,” said Mark Allegretta, Ph.D., the Associate Vice President of Commercial Research at the National Multiple Sclerosis Society. “We are pleased to partner with Bionure to accelerate the development of its novel neuroprotective and remyelinating compound. Protecting and repairing the nervous system holds promise for people with progressive forms of MS, for whom there are so few treatment options.”
The Company’s short term strategy is to bring BN201 to Phase IIa testing, and work on closing co-development and licensing agreements with select drug development companies. Clinical trials for BN201 are expected to open within Q2 of 2015.