INM-755 Cannabinol Cream Shows Good Safety Profile in Healthy Volunteers
INM-755, an investigational cannabinol cream for epidermolysis bullosa (EB), showed a good safety profile in a Phase 1 clinical trial conducted in healthy volunteers, according to a press release from InMed Pharmaceuticals, which is developing the treatment.
INM-755 is a topical cream containing cannabinol (CBN), a compound found in small amounts in the cannabis plant. The cream, which is being developed to treat symptoms of EB and other skin conditions, was designed to increase skin integrity by raising levels of keratin — a structural protein in the skin, hair, and nails. Preclinical data indicate that the investigational therapy may ease inflammation, itching, and pain in people with EB.
The Phase 1 trial known as 755-101-HV enrolled 22 healthy volunteers (without EB). Participants were given two strengths of INM-755, or a placebo (cream containing no CBN). The cream was applied to the entire upper back of each participant — representing about 5% of the total surface area of their bodies — which was then covered with a bandage. This was repeated daily, for two weeks.
According to InMed, these treatment procedures were intended to create intense conditions for evaluating skin irritation potential, as they simulate what happens in EB patients with large areas of skin covered with a dressing.
Over the treatment period, most participants in all groups reported no adverse events on the majority of the treated area. Reactions were generally mild or moderate, and resolved without additional treatment. A slightly higher incidence and intensity of redness (erythema) and scaling was found among those given INM-755 than in participants given the placebo. Similar results were found for both tested doses of the investigational cream.
Notably, since redness and stinging/burning were reported in both groups, these reactions may be at least partly attributed to the strenuous bandaging, and not the cream itself, said InMed.
Very low levels of CBN were identified in the blood of participants given INM-755. No systemic adverse events were found; in other words, all reported problems affected the site where the cream was applied, without causing problems throughout the body.
In addition to systemic safety evaluations — physical examinations, laboratory analyses, etc. — participants were asked about their internal and external perceptions, and whether they “felt high.” CBN is slightly psychoactive, meaning that it can cause a “high” when present at elevated enough levels in the body. However, none of the participants reported any such effects.
“In summary, these results demonstrate an acceptable local safety profile of treating intact skin in healthy volunteers and indicate only low-level systemic exposure from topical administration,” the release stated.
InMed is currently conducting a second Phase 1 trial, called 755-102-HV, to test two strengths of INM-755 cream on open skin wounds in eight healthy adults over 14 days. This trial recently completed treatment, and results are expected early next year.