InVivo Therapeutics Announces Topline Data from Pivotal INSPIRE 2.0 Study in Acute Spinal Cord Injury
Study did not achieve primary endpoint of defined improvement on standard impairment scale
InVivo to evaluate full data set and strategic options for the company
Excerpt from the Press Release:
CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV), a research and clinical-stage biomaterials and biotechnology company with a focus on the treatment of spinal cord injuries (SCI), today announced topline results from the company’s INSPIRE 2.0 study, which was designed to evaluate the safety and probable benefit of InVivo’s investigational Neuro-Spinal Scaffold™, a bioresorbable scaffold-based device in development for patients with acute SCI. The study did not meet its primary endpoint, which was assessed by the proportion of treated patients achieving an improvement of at least one American Spinal Injury Association (ASIA) Impairment Scale (“AIS”) grade at six months post-scaffold implantation, versus a control group that received standard of care surgery.
“We are disappointed by the outcome of this study as treatments for spinal cord injury are so urgently needed and we know many in the SCI patient and advocate community wait in hope for therapeutic options. We have rigorously pursued the science and believe that, upon full assessment, the INSPIRE 2.0 data set will provide a significant addition to the clinical literature around the treatment of SCI,” said Richard Toselli, M.D., InVivo’s President and Chief Executive Officer. “I extend our deepest thanks to our patients and clinical sites who have supported InVivo’s work to bring our science to patients, and the InVivo team who have tirelessly pursued our mission.”
InVivo management will conduct a full assessment of the study data set and plans to share its findings in full in a peer-reviewed medical venue at a later date. The company will also evaluate its strategic options and provide an update on corporate direction when appropriate.
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