InMed Asking to Open Phase 2 Trial of INM-755, Cannabinol Cream for EB
InMed Pharmaceuticals has submitted applications to regulatory authorities in Austria, Israel, and Serbia, seeking clearance to begin clinical testing of its investigational cannabinol cream INM-755 in people with epidermolysis bullosa (EB).
Similar applications to authorities in France, Germany, Greece, and Italy are expected in the coming weeks. Responses to these applications are expected this summer, but exact timing varies country-by-country.
“It is very exciting to be taking this important next step to test the efficacy of our cannabinol cream in EB patients,” Alexandra Mancini, senior vice president of clinical and regulatory affairs at InMed, said in a press release.
“Once we receive the necessary approvals, patient enrollment will begin as soon as possible, with results expected in the second half of 2022,” Mancini added.
The planned Phase 2 clinical trial is expected to take place at 10 pre-qualified clinical sites. Approximately 20 patients are to be enrolled over about one year. The study will be open to people with all four types of inherited EB (EB simplex, dystrophic EB, junctional EB, and Kindler syndrome).
It will test the safety of INM-755 treatment in these patients, and preliminarily assess the investigational cream’s efficacy in treating symptoms and healing wounds over a 28-day period.
The study will use a within-patient, double-blind design — that is, each patient will have INM-755 applied to some parts of the skin, while other areas of their body will be treated with a vehicle (the cream with no active ingredient), and comparisons will be made between the two.
The active ingredient in INM-755 is a cannabinol (CBN), a molecule found in small amounts in the cannabis plant. INM-755 is designed to ease EB symptoms by increasing levels of the structural protein keratin in the skin.
Two prior clinical trials evaluated INM-755 in healthy volunteers. In one, participants were given the cream on the entire upper back, with extensive bandaging meant to mimic the kind of extensive bandaging EB patients can experience. In the other, open wounds were created from small and induced blisters, and then treated with either INM-755 or a vehicle.
Both trials demonstrated that INM-755 was generally well-tolerated, and INM-755-treated participants did not report feeling “high” (CBN is slightly psychoactive). Prior findings also showed that the experimental cream did not interfere with normal wound healing.
“We are optimistic, based on our preclinical studies, that INM-755 cream may provide some much-needed help for [EB] patients,” Mancini said.