BN201 is a new chemical entity, highly soluble small molecule, selected from a library of chemicals by using tests screening for neurotrophic and neuroprotective properties (phenotypic tests).
BN201 displays a unique mode of action targeting protection of the axon and the myelin sheath allowing the drug candidate to interfere with the mechanisms leading to demyelination and neuronal death.
BN201 crosses the blood brain barrier and demonstrated neuroprotective activity in several preclinical models by providing axonal protection, remyelination and promotion of neuronal survival in front of different types of damage. These pathological effects translated in improvement of clinical symptoms. BN201 has been tested in reference models of acute optic neuritis, multiple sclerosis and glaucoma.
BN201 has successfully completed a clinical Phase 1 study on testing the safety, tolerability and pharmacokinetics of single and multiple doses of BN201 in healthy volunteers under the approval of the Regulatory Authority MHRA, UK.
The results of the randomized, double-blind, placebo-controlled Phase 1 study performed in 48 healthy volunteers showed good correlation with pharmacokinetic data generated in animal studies. No drug-related safety or tolerability issues were reported in the tested dose range.