InVivo Therapeutics (NSDQ:NVIV) today released updated results from the Inspire study of its neuro-spinal scaffold but said that it would not be reopening enrollment, which it paused last July, and is instead looking to a new randomized controlled trial to supplement the results.
The Cambridge, Mass.-based company said that 43.8% of the 16 living patients in the trial who had been implanted with the scaffold had reached the primary endpoint of an AIS grade improvement at six months. The objective performance criterion for he study had been a 25% AIS conversion rate, InVivo said.
The last patient to reach the primary endpoint was assessed to be AIS C motor incomplete at six months, with some motor function detected on the sacral level. Of the total seven Inspire patients who had AIS improvements at six months, five improved from complete AIS A SCI ratings to sensory incomplete AIS B SCI ratings, and two patients improved from complete AIS A SCI ratings to motor incomplete AIS C SCI ratings.
A total of two of the five patients assessed at AIS B at six months showed improvements to AIS C ratings at 1 and 2 years respectively, InVivo Therapeutics said.
The company halted enrollment last July after a third patient died shortly after being discharged from the hospital after implantation. While the death was deemed to be unrelated to the neuro-spinal scaffold or the implantation procedure, the company said it was initiating a temporary enrollment halt while it explored possible trial changes with the FDA.
In continued discussions with the FDA, InVivo said it has proposed a randomized controlled trial to supplement its existing evidence, and does not plan to re-open enrollment in the trial but will provide “additional clarity on its clinical path forward in the second quarter of 2018.”
“I am pleased to report the latest AIS conversion results from Inspire. Inspire demonstrated the surgical feasibility of neuro-spinal scaffold implantation and produced encouraging data on AIS conversions at six months compared to the objective performance criterion and natural history reported in the literature. We remain in discussions with the FDA regarding the clinical path forward in support of a Humanitarian Device Exemption filing. We are working diligently to provide clarity as expeditiously as possible as we evaluate various strategic and financing options. I look forward to providing more details on our proposed randomized controlled study in the second quarter of 2018,” acting CEO Richard Toselli said in a press release.
Last August, InVivo said it was laying off nearly 40% of its workforce, pausing its Inspire clinical trial and cutting two R&D programs as it tries to get its a pivotal study back on track.