INM-755, an investigational cannabinol cream for epidermolysis bullosa (EB), showed a positive safety profile and did not interfere with normal healing in a Phase 1 clinical trial conducted in healthy volunteers with open wounds, according to a press release from the cream’s developer, InMed Pharmaceuticals.
INM-755 is a topical cream that contains cannabinol (CBN), a molecule found in small amounts in the cannabis plant. The cream is being developed to treat symptoms of EB and other skin conditions; it is intended to increase skin integrity by raising levels of the structural protein keratin.
The 755-102-HV Phase 1 clinical trial — also called Study 102 — was a randomized, single-center study in eight healthy adults to test the tolerability of two weeks of application of the cream.
On the first day of the trial, each participant had four small blisters created via suction on their skin. The roof of each blister then was pierced, the fluid drained, and the skin on top of each blister removed to create an open wound.
In each participant, two of the wounds were treated with two strengths of INM-755 cream. A third wound was treated with a vehicle (cream that contained no CBN), while the fourth wound was left untreated.
The treatment was put on a film dressing that was applied to the wound and surrounding area; each treatment was repeated daily for 14 days. The participants were followed for an additional week afterward.
Results showed no systemic or serious side effects, and no participants withdrew from the trial due to adverse events. In addition, comparisons in each person showed that INM-755 did not interfere with normal wound healing.
Throughout the study, an investigator — who was blinded to which treatment was which — assessed the wounds for four parameters: local erythema (redness); scaling; a stinging/burning sensation; and edema (swelling).
Most occurrences of erythema were mild or moderate, and there were no differences across the treatment groups. Likewise, no differences were seen in scaling across the groups, and most cases were mild. Stinging/burning was not observed with the high concentration cream or in the untreated wounds; a few mild instances of stinging/burning were reported with the vehicle and low concentration creams. No edema was observed for any of the treatment groups.
“In summary, the safety and tolerability evaluations demonstrated that INM-755 cream was well tolerated on open wounds and caused no delay in wound healing,” the InMed release stated.
The findings from this trial complement positive safety results from another Phase 1 trial, in which INM-755 was applied to the entire upper back of each participant and bandaged for two weeks, simulating what happens in EB patients with large areas of skin covered with a dressing.
InMed now plans to seek regulatory approval to conduct clinical trials of INM-755 in EB patients. The company said it will submit applications in several countries in the first half of this year.
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