InVivo Therapeutics is to cease enrolment in its recently-announced cervical study of the company’s Neuro-spinal scaffold. The company has also halted its chronic spinal cord injury stem cell and gene therapy research programmes, and reduced its staff by 13 (approximately 39%).
This “strategic restructuring” is intended to allow the company to focus on completing its flagship INSPIRE (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury) trial, a press release states.
The new focus may allow the company to reopen enrolment in the INSPIRE Study—which is currently paused—and to file a Humanitarian Device Exemption submission for the Neuro-spinal scaffold to the US Food and Drug Administration (FDA).
The INSPIRE Study is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold in patients with complete thoracic spinal cord injury, and currently has 16 patients in follow-up.
INSPIRE—which has reported positive results in for a number of its participants—has 34 sites accross the USA, Canada and the UK.
According to the release, the company is “evaluating strategic options for allowing the cell and gene therapy programs to move forward outside of the company.” Once the FDA approves a protocol allowing for enrolment in the USA, the company plans to restart the trial.
The company believes that this significant restructure will lead to 2018 operating expense savings of approximately US$7.3 million and to reduce 2018 cash burn from approximately US$2.0 million per month to approximately US$1.5 million per month.
“I feel confident that going forward, we have aligned our operational efforts and financial resources to fully support our core goal of bringing the Neuro-spinal scaffold to market. We continue to work with the FDA as expeditiously as possible with the goal of reopening enrolment in INSPIRE, and we look forward to completing the study and submitting our HDE application,” InVivo’s chief executive officer and chairman, Mark Perrin, says.
INSPIRE is registered in the USA at clinicaltrials.gov.