Bionure, a spin-off from Hospital Clínic de Barcelona that is based in California, is developing a neuroprotective and myelination-promoting therapy called BN201 for multiple sclerosis, acute optic neuritis (AON) and glaucoma. BN201 was granted with orphan designation status for optic neuritis by the FDA. Optic neuritis is often an early sign of multiple sclerosis.
History of BN201
BN201 is a small peptide molecule, a first-in-class neuroprotective compound. In January 2015, Bionure entered a Sponsored Research Agreement with the National Multiple Sclerosis Society to fund the drug’s late preclinical development. Previous preclinical studies that Bionure conducted with the Myelin Repair Foundation, in a cell-culture assay, determined that BN201 promoted myelination, the cellular process of repairing the protective myelin sheath surrounding nerves that is damaged in MS.
How BN201 Works
The mechanism of action of BN201 differs from the conventional immunomodulating drugs for MS treatment in targeting brain damage and neurodegeneration as a whole, instead of the inflammatory pathways. Beyond its neuroprotective activity in neurons, the compound has been shown to stimulate remyelination by differentiating oligodendrocyte precursor cells into mature oligodendrocytes and promoting the formation of myelin sheaths around axons. Protecting the nervous system from damage and reversing the damage through myelin repair has the potential to restore function to people with optic neuritis and multiple sclerosis.
Next Steps For BN201
The efficacy, safety, and capacity of the drug to cross the blood-brain barrier have been demonstrated in animal models, but the drug has not yet entered clinical testing. The company announced that it has opened a $30 million Series A funding round by 2017 and expects an early entry into the market in neuromyelitis optica by 2018.
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