News that Nexstim’s brain-stimulation technology has not shown a benefit in stroke sent the company’s stock plummeting by around 70% today, and the flop in the pivotal trial's interim analysis makes it unlikely that the Finnish group will continue development of its Navigated Brain Therapy. It had ended 2015 with cash reserves of €6.9m, only enough to get it to September at current burn rates.
Even worse, Nexstim will be forced to see out the Niche trial, since the data safety monitoring board has recommended that the study remain blinded and that full data have to be collected. Completion is also set for September, meaning that rather than scrapping it and conserving money it has to fund it until its cash runs out – barring a severely discounted fund-raising.
The company noted that enrolment and treatment had been completed, and during a conference call to discuss its annual results its chief executive, Janne Huhtala, pointed out that the most expensive part of the trial had been done, although “certain overheads continue”. However, when pushed he would not give any more insight into Nexstim’s plans, saying it would analyse the situation and put out an update “in due course”.
The company had been hoping that its therapy, which involves the noninvasive application of an electrical field to the brain, would boost the effect of physiotherapy in stroke rehabilitation. But an interim analysis of the first 138 patients enrolled in Niche concluded that it would not meet its primary endpoint, improvement in a measure of upper limb motor function versus sham treatment at six months.
Nexstim’s Navigated Brain Therapy system uses transcranial magnetic stimulation to generate a precisely targeted electric field in the brain, attenuating activity directly opposite the lesion site. The idea is that by temporarily dialling down the healthy side of the brain, which would usually take over from the damaged part, the nerves in the site affected by the stroke have room to improve.
The method had previously shown an “unheard of” 84% response rate in a phase I/II trial, which used the same endpoint as the Niche study, the upper extremity Fugl-Meyer scale (Interview – Nexstim aims to electrify post-acute stroke, May 06, 2015).
But this result has not been replicated, and it is back to the drawing board for Nexstim. The company does already sell the Navigated Brain Therapy system in Europe for stroke rehab and major depression, and a similar technology is approved in the US and Europe for brain mapping before neurosurgery. It reported revenues of €2.5m in 2015, up 14% year-on-year.
However, US approval in stroke rehab had been the main prize, with Nexstim estimating its target market at $1.8bn.
The Finnish group is not the only one to run into problems trying to expand neuromodulation out of current uses in pain and movement disorders – efforts to show that vagus nerve stimulation could treat heart failure also hit a brick wall (ESC – Cyberonics fails a bit better than Boston, September 01, 2014).
And it seems that Navigated Brain Therapy in stroke is also destined for the scrapheap – unfortunately for Nexstim.
|Study||Primary endpoint||Trial ID|
|Niche||Upper extremity Fugl-Meyer score versus sham treatment||NCT02089464|