cell survival and endogenous natural repair

Bionure initiates a Phase 1 clinical trial of its lead compound BN201 in the United Kingdom

Bionure announces today the initiation of a Phase 1 clinical trial of its lead compound BN201 in the United Kingdom. The compound is intended for the treatment of Acute Optic Neuritis (AON) and Neuromyelitis Optica (NMO).


BN201 is a first-in-class compound that promotes cell survival and endogenous natural repair by activating SKG2, an intracellular serine/threonine kinase that plays a crucial role in the response of neurons to stress and its survival. The Phase 1 clinical trial is intended to investigate safety, tolerability and pharmacokinetics of single and multiple doses of BN201 in healthy volunteers. Results are expected by the end of the year and the company’s plan is to start a Phase 2a trial in 2019.


Currently, there are no therapeutic drugs in the market for AON and NMO. Patients are treated with corticosteroids and immunomodulators that reduces inflammation but do not repair the nerve damage. BN201 has demonstrated neuroprotective activity and stimulates remyelination by differentiating OPCs (Oligodendrocyte Progenitor Cells) into mature oligodendrocytes and thus promoting the formation of myelin sheaths around axons. Both actions make BN201 a promising solution for AON and NMO patients and open a research pathway to treat other neurodegenerative diseases such as Multiple Sclerosis (MS).


“The start of the Phase I clinical trial is an important milestone for Bionure. We are excited to see BN201 move forward into the clinic, one step closer to reaching patients.”, said Mar Massó, Managing Director of Bionure.