electroCore has announced that its successful funding initiative of US$40 million, announced in April last year, has been oversubscribed by US$10 million by all parties including Merck’s Global healthcare Innovation fund and private equity groups Easton Capital and Core Ventures. The final tranche of US$15 million of the US$40 million was optional but following discussions between the investors this was not only made compulsory but increased by US$10 million to a total of US$50 million.
electroCore has developed and patented a non-invasive vagus nerve stimulation (nVNS) therapy for the treatment of a variety of conditions in neurology, psychiatry, gastroenterology and other conditions.
Its focus, at present, is primary headache – cluster and migraine – where it is just concluding four randomised studies in Europe and the USA. The European randomised PREVA study, for the prevention and acute treatment of chronic cluster headache, last week achieved statistical significance on its primary endpoint by reducing the number of cluster headache attacks per week by 47.5% in patients treated with nVNS compared to 12.1% in patients treated with the best available standard of care.
In Europe, the nVNS technology, as delivered by electroCore’s gammaCore device is considered CE markable, and a CE mark has been awarded in primary headache, bronchoconstruction, epilepsy, gastric motility disorders and depression and anxiety. In the US the pivotal trial for headache is just finishing and an application for a US license will follow.
Surgically implanted vagus nerve stimulation (VNS) has been proven for more than twenty years, and in more than 100,000 patients, to be an effective and safe therapy for the treatment of refractory epilepsy and depression but because of its high cost and invasiveness it has been relegated to the end of the continuum of care.
JP Errico chief executive officer and founder comments: “It has been known for years that vagus nerve stimulation relieved a whole variety of conditions including headache, bronchoconstruction, and many other symptoms but because of its US$30,000 cost it was not considered. We believe that we have revolutionised this effective treatment by proving that our inexpensive nVNS therapy is just as effective as surgically implanted and can be used by millions of patients to self-treat their particular condition. Our nVNS therapy does one thing, it reduces the over expression of the excitatory neurotransmitter glutamate which has been implicated in a number of these disorders. This appears to be born out from the very encouraging signals we are getting from our clinical programme in headache as well as observational and open label studies across a number of these conditions.”
At the Royal Free Hospital in London the company is running a double-blind, parallel, sham controlled trial in patients with two of the most common gastrointestinal complaints; Irritable Bowel Syndrome and functional dyspepsia. This follows a successful proof of concept assessment in patients with gastroparesis.
electroCore is involved in clinical trials in universities across Europe and plans to extend this to the US after receiving FDA approval.