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

17.05.2018

Bionure, a biotech company based in the Barcelona Science Park that develops neuroprotectant agents to treat neurodegenerative diseases primarily focusing on rare ophthalmologic diseases, announces today the initiation of a Phase 1 clinical trial of its lead compound BN201 in the United Kingd. BN201 is a first-in-class treatment that promotes remyelination and neuroprotection, offering a game-changing solution for neurodegenerative diseases. Both actions make BN201 a promising solution for rare ophthalmologic diseases  and open a research pathway to treat other neurodegenerative diseases such as Multiple Sclerosis (MS). 

 

Mar Massó, managing director of Bionure (Photo © Bionure).

Currently, there are no therapeutic drugs in the market for Acute Optic Neuritis (AON) and Neuromyelitis Optica (NMO). Patients are treated with corticosteroids and immunomodulators that reduces inflammation but do not repair the nerve damage. 

BN201 is a first-in-class compound that promotes neuroprotectio, 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. 

BN201 has also 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 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.

“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, new managing director of Bionure.

Changes in the Board and €4M Series A round

The beginning of the clinical trial marks the highlight of the next stage initiated by Bionure, a spin-off company based on a August Pi i Sunyer Biomedical Research Institute-IDIBAPS (Hospital Clínic–UB–CSIC) research, which was started by Dr. Pablo Villoslada and Albert G. Zamora. The biotech company has renewed of its Board of Directors.The board is now chaired by Guy P. Nohra, founder of Alta Life Sciences, co-founder of Alta Partners ($2 billion raised from 1996 to 2006) and expert LS investor. In addition, Paul Frohna, MD, Rajiv Mahadevan and Josep Herrero have joined the board along with Montserrat Vendrell from Alta.

Alta Life Sciences is leading a Series A round of 4 million euros to finance the clinical development of the BN201 for AON and NMO, that affects 130,000 patients a year only in United States and Europe which give a potential market of about €1,000 million/year.

Moreover, Neuro-ophthalmologist Craig Smith, until now a member of the Scientific Advisory Board of Bionure, is joining the company as chief medical officer. “BN201 has demonstrated benefits in several animal models of damage, including demyelination, inflammation and neurodegeneration, and has been shown to promote neuronal and axonal protection and myelin repair,” stated Dr. Smith. “We believe that BN201 has the potential to provide a novel therapeutic approach for AON, NMO and Multiple Sclerosis patients”.

Dr. Smith brings his long experience in companies such as Genentech and Novartis, leading teams in neuroscience and ophthalmology. Dr. Smith is a senior/advisor/consultant with the Bill and Melinda Gates Foundation and throughout his career he has led several investigations in Optic Neuritis and Multiple Sclerosis. 

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