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 (MS), and for acute optic neuritis (AON) and glaucoma. As a neuroprotective drug candidate, BN201 may represent a new approach in MS treatment.
History of BN201
BN201 is a small peptide molecule, a first-in-class neuroprotective compound that has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA). 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. According to Bionure, BN201 has been shown in several animal models to promote neuroprotection by protecting and preventing axonal loss and neuronal death.
It also has demonstrated remyelinating potential by differentiating oligodendrocyte precursor cells (OPCs) into mature oligodendrocytes, and in promoting the formation of myelin sheaths around neurons.
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 had opened a $30 million Series A funding round in 2015, with the goal of beginning clinical studies of BN201 to treat AON. Optic neuritis is often an early sign of multiple sclerosis.
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