A total of five patients have been enrolled into The INSPIRE 2.0 Study (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), bringing the study to 25% completion of targeted enrollment. The first patient was enrolled into the INSPIRE 2.0 Study in May of 2019, and 14 sites are currently open for enrollment into the study. InVivo Therapeutics Holdings Corp announced the news today.
Richard Toselli, M.D., President and Chief Executive Officer of InVivo, said, “We made a dedicated effort to efficiently activate strategic clinical sites during the first half of the year and are pleased with the resulting pace of enrollment to date, with our team maintaining focus on enrollment efforts and engagement at the site level. In addition, we appreciate the investigators’ support of this trial, which we believe has the potential to address a long unmet medical need for spinal cord injury patients.”
The INSPIRE 2.0 Study is a two-arm 20-patient (10 subjects in each study arm), randomized, controlled trial designed to provide clinical data that will supplement the existing clinical results from the company’s previous single-arm study (INSPIRE 1.0). The definition of study success for the INSPIRE 2.0 Study is that the difference in the proportion of subjects who demonstrate an improvement of at least one grade on ASIA Impairment Scale assessment at the six-month primary endpoint follow-up visit between the Scaffold Arm and the Comparator Arm must be equal to or greater than 20%.