Attacking an early MS sign

Collaboration keeps first-in-class neuroprotective agent in acute optic neuritis on track for early clinical trials

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BARCELONA, Spain—Bionure Inc., which has operations both in Spain and Menlo Park, Calif., entered into a sponsored research agreement in late January with the National Multiple Sclerosis Society (NMSS) to support the development of BN201, a first-in-class neuroprotective and remyelinating agent indicated in acute optic neuritis (AON)—inflammation of the optic nerve known to be one of the earliest signs of multiple sclerosis (MS).
Under the terms of the agreement, late-preclinical development of BN201—Bionure’s lead compound—will be funded through Fast Forward, the commercial research subsidiary of the NMSS that is focused on accelerating the development of new or improved therapies for MS. The Fast Forward program’s backing is intended to enable the filing of an Investigational New Drug (IND) application for BN201 with the U.S. Food and Drug Administration (FDA) to support an anticipated Phase 1 clinical study in AON.
BN201 is a small-molecule, new chemical entity that has shown evidence of promoting both neuroprotection and remyelination in several animal models. BN201 has been granted orphan designation for optic neuritis in Europe and the United States.
“BN201 is promising because it targets a molecular pathway that has not been previously targeted for MS,” says Dr. Mark Allegretta, associate vice president of commercial research for the NMSS. “The compound is brain-penetrant and has activity as a neuroprotective agent, stimulating a pathway known to promote survival in neurons. The compound protects the spinal cord, optic nerve and retina from axonal/neuronal degeneration and demyelination.”
Additionally, BN201 shows the ability to promote oligodendrocyte precursor cells’ maturation into mature oligodendrocytes, which then produce myelin to begin remyelination of nerve cells. The loss of the myelin sheath that insulates nerves in the central nervous system, or demyelination, is a condition characteristic of multiple sclerosis and several other neurodegenerative autoimmune disorders. The induction of remyelination is thought to be essential to the process of restoring nerve function, says Allegretta.
Bionure researchers believe that protecting the nervous system from damage and reversing existing damage through myelin repair has the potential to restore function to people with optic neuritis and multiple sclerosis.
The review committee of the NMSS believed BN201 was a good candidate for funding through the Fast Forward program because of its promising early preclinical in-vitro and in-vivo results in the area of neuroprotection and repair and the satisfactory safety profile demonstrated in the compound’s early toxicology studies.
“The compound was at the stage in development where it needed funding to transition towards IND-enablement, an area of particular focus for Fast Forward, which looks for early-stage, potentially promising MS treatments in order to de-risk drug development,” says Allegretta. “By funding this challenging stage in the process, Fast Forward aims to improve the company’s ability to attract additional investment.”
The collaboration keeps Bionure on track for a Phase 1a/1b study, with the company planning to file for an IND application with the FDA to conduct a Phase 1 clinical trial in AON. Clinical trials for BN201 are expected to open within the second quarter of 2015.
Bionure’s short-term strategy is to bring BN201 to Phase 2a testing and to secure co-development and licensing agreements with select drug development companies. In 2014, Bionure opened a $30-million Series A round of funding to obtain a clinical proof of concept in AON by 2017 and early entry into the market in neuromyelitis optica by 2018.
“We are excited to collaborate with the National MS Society towards accelerating BN201 into clinical trials for AON,” said Bionure CEO Albert G. Zamora in a statement announcing the agreement. “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.”

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