Winning the game to neurodegenerative diseases: the new BN201 drug of Bionure powers neuroprotection and remyelination.

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BN201 is the first  SGK2 selective agonist in its class that promotes remyelination and neuroprotection, by offering a solution that changes the playing field in the treatment of neurodegenerative diseases, giving us certain advantages to begin to combat them.

Has recently been initiated its phase 1 clinical trial in the United Kingdom, and in order to speed up and tie well each place in the development of this new drug, the company Bionure has reconstituted its Board of Directors and has been added to the prominent neuro-ophthalmologist Dr. Craig Smith as new Medical Director, with which them expect to successfully manage this process.

Bionure It is a biotechnology company with headquarters in Barcelona which develops neuroprotective agents to treat neurodegenerative rarediseases in the field of ophthalmology. Mainly is centered in the field of Acute Optic Neuritis (AON), and Optic Neuromyelitis (NMO). Since its founding in 2009 by Dr. Pablo Villoslada and Albert G. Zamora, and emerged as a spin-off of the Hospital Clínic of Barcelona, Bionure has obtained for its main candidate BN201 the orphan drug designation for the Optic Neuritis in Europe and the United States, and has shown evidence of neuroprotection and remyelination in different animal models.

Currently, there is no therapeutic drugs on the market for Acute Optic Neuritis (AON), and Optic Neuromyelitis  (NMO). Patients are treated with corticosteroids and immunomodulators that reduce inflammation but not repaired the nerve damage. BN201 has shown neuroprotective activity and stimulates remyelination through differentiation of oligodendrocytes progenitor cells (OPCs) in mature oligodendrocytes and thus promoting the formation of myelin sheath around axons.

Both of these actions make BN201 as promising solution for patients with AON and NMO and open a way to treat other neurodegenerative diseases such as multiple sclerosis (MS).

It should be noted that the optic neuritis is often a first sign of the development of multiple sclerosis (MS), so that the drug has the potential to be used in the future for the treatment of other neurodegenerative diseases without specific therapies as the latter.

BN201 is the first in its class that promotes cell survival and the endogenous natural repair through the activation of SKG2, an  intracellular serine/threonine kinase that plays a crucial role in the response of the neurons to stress and their survival. The Phase 1 clinical trial aims to investigate the safety, tolerability and pharmacokinetics of single- and multiple-dose of BN201 in healthy volunteers. The results are expected for the end of the year and the company’s plan is to begin a phase 2a trial in 2019.

“The start of the Phase I clinical trials is an important milestone for Bionure. We are excited to see that BN201 advances in the clinic, a step closer to patients,” said Sea Masso , managing director of Bionure.

The beginning of the clinical trial marks the culminating point of the next stage initiated by Bionure, and for their development has renewed its Board of Directors. It is now chaired by Guy P. Nohra , founder of High Life Sciences, co-founder of Alta Partners (with 2 billion $ collected between 1996 and 2006) and expert investor LS (Life Science). In addition, Paul Frohna , MD, Rajiv Mahadevan and Josep Herrero have joined the board together with Montserrat Vendrell High-LS. Salut Monràs , Bionure investor, and Sea Masso, managing director of Bionure, complete the Board.

But the renewal of the Board has not been the only change in the company. The neuro-ophthalmologist Craig Smith, until now a member of the Scientific Advisory Board of Bionure, joins the company as the Chief Medical Officer (CMO). Dr. Smith brings its long experience in companies such as Genentech and Novartis, teams in neuroscience and ophthalmology. It is principal adviser to the Bill and Melinda Gates Foundation and throughout his career he has directed several research on optic neuritis and multiple sclerosis.

“BN201 has proven benefits in several animal models of damage, including the demyelination, inflammation and neurodegeneration, and it has been shown that promotes the protection neuronal and axonal myelin repair,” said Dr. Smith. “We believe that BN201 has the potential to provide a new therapeutic approach for AON, NMO and multiple sclerosis patients “.

“The addition as CMO of Dr. Craig Smith will undoubtedly give us a valuable impetus to the clinical development of BN201 “, said Guy P. Nohra, president of Bionure. 

High Life Sciences is leading a series A round of 4 million euros to finance the clinical development of BN201 for AON and NMO, diseases that affect 130.000 patients per year in the United States and Europe and that have a potential world market of around € 1.000 million / year.

 

The Acute Optic Neuritis (AON), and Optic Neuromyelitis (NMO) are eye diseases caused by an autoimmune reaction that causes inflammation and demyelination of the optic nerve (that can spread to the spinal cord and brain in NMO). Currently, patients with AON and NMO are treated with corticosteroids and immunomodulators that reduce inflammation but do not regenerate the damage of the nerve. There is a drug approved to treat AON and NMO.

Multiple sclerosis is a unpredictable disease, often disabling disease of the central nervous system that interrupts the flow of information within the brain and between the brain and the body. In progressive forms of MS  chronic neurodegeneration occurs that results in the progression of a invalidating state. So far, the therapies that are effective for relapse of MS have shown between limited to no efficacy in MS.

This disease affects more than 400,000 people in North America, approximately 500,000 in Europe and 2.5 million in all over the world.  The average onset of the disease is 30 years, and like many autoimmune diseases, have a inbalance distribution by gender and affects women more often than men, this is also valid for multiple sclerosis, representing the number of affected women double than men.

For all these reasons, new therapies that allow us to protect and repair the nervous system are a promising approach for people with progressive forms of multiple sclerosis and other neurodegenerative diseases, for whom there are so few treatment options.

 

Image credits BlueRingMedia, Designua, CI Photos, Andrii Vodolazhskyi, ellepigrafica, Ralwel, CLIPAREA l Custom media /shutterstock.com

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