Spanish biotech Bionure has started an early stage trial of a new drug to treat rare neurologic eye diseases, which also shows promise for treatment of multiple sclerosis and other similar conditions.
The therapy (BN201) is the first its class and if successful in clinical trials will be the only treatment that can help repair the damage caused by rare eye conditions such as acute optic neuritis and neuromyelitis optica. No other treatments of this type are currently available, although other players such as MedDay have also been investigating therapies in this field with varying success.
These conditions affect around 130,000 patients a year in the US and Europe and, in around a third of cases, optic neuritis is one of the early signs of multiple sclerosis. They involve damage to the optic nerve that can cause pain and sight loss. People who are affected are currently given corticosteroids and immunomodulating drugs to reduce inflammation, but these treatments cannot repair the nerve damage caused by either disease.
The new therapy has been tested in animals and will now be tested in humans in a Phase I trial in London. It has already been granted ‘orphan’ status for optic neuritis in Europe and the United States. It works by triggering young and unformed neural cells to produce new myelin sheath to repair the damage and replace cells destroyed by the disease. The trial is only the first step towards getting this treatment to the clinic and will test dosage and safety in healthy volunteers.
As part of the new stage in its development, the company has renewed its Board of Directors and has appointed a top neuro-opthalmologist as its Chief Medical Officer. One of the company’s key investors is Alta Life Sciences, its founder is also the Chair of Bionure‘s Board. Alta is leading a financing round of €4M to fund clinical development of the drug candidate.
“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,” commented Bionure’s CMO Craig Smith. “We believe that BN201 has the potential to provide a novel therapeutic approach for acute optic neuritis, neuromyelitis optica and multiple sclerosis patients.”
If the trial is successful, the company hopes to begin a Phase 2 trial in patients with these eye conditions in 2019.
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