InMed Pharmaceuticals Inc. announced that all subjects participating in its second Phase 1 clinical trial with INM-755 have completed treatment. INM-755 is being developed as a topical CBN-based cream to potentially treat Epidermolysis Bullosa (“EB”) as well as potentially other dermatological diseases.
The 755-102-HV clinical trial is a randomized, double-blind, vehicle-controlled, Phase 1 study designed to evaluate the safety and tolerability of INM-755 cream applied daily on epidermal wounds in healthy volunteers. Eight adult subjects were treated with two strengths of INM-755 cream over a 14-day treatment period. As with InMed’s first Phase 1 clinical trial with INM-755, the 755-102-HV trial is being conducted at the Centre for Human Drug Research in Leiden, the Netherlands.
Despite the COVID-19 pandemic and the resulting restrictions that have affected clinical development programs worldwide, the full treatment phase of this second Phase 1 trial was achieved with only a modest delay to the original timeline. With completion of both the 755-101-HV and the 755-102-HV treatment phases, and assuming positive safety and tolerability data of INM-755 on both intact skin and epidermal wounds, the Company will be better positioned to advance detailed planning for the first efficacy trial in EB patients.
InMed anticipates reporting results from both Phase 1 trials in the second half of calendar 2020 and, assuming a positive safety profile for INM-755, submitting regulatory filings for the first efficacy trial in EB patients in early 2021.