InMed Pharmaceuticals Inc. announced that all subjects participating in its 755-101-HV Phase 1 clinical trial have completed treatment and clinical evaluation.
Study 755-101-HV is a randomized, vehicle controlled, double-blind, Phase 1 trial, examining the safety and tolerability of two strengths of INM-755 cream in 22 healthy adult volunteers over a 14-day treatment period. With treatment completed, InMed continues to anticipate reporting final study results in the second half of calendar 2020.
“The end of the treatment phase is an exciting milestone and we now progress into sample analysis and data review,” said Alexandra Mancini, Senior Vice President of Clinical and Regulatory Affairs. “The interim safety analysis of the blinded data from the first 16 subjects who had completed at least one week of treatment in this trial supported moving forward with activities to launch a second Phase 1 trial.” The Clinical Trial Application (“CTA”) for InMed’s second Phase 1 study with INM-755, Study 755-102-HV, was filed March 23, 2020.
Some aspects of biological sample and data analyses will be delayed by COVID-19 pandemic-related restrictions and will impact the timing of announcing final study results. InMed is continually reviewing timelines, given current work restrictions in the Netherlands where our Phase 1 studies are being conducted. Changes to INM-755 program timelines, including enrollment in the 755-102-HV trial and the subsequent timing of regulatory filings in preparation for an initial EB patient trial, will be communicated as the Company gains additional information.
In addition, InMed President and CEO Eric A. Adams added, “We want to reassure our stakeholders that our clinical studies and subsequent sample analyses are conducted outside of the hospital setting, and, therefore, do not compete for the critical resources and medical staff needed to address this pandemic. We also continue to take all possible and responsible measures to protect our staff and minimize business disruption.”