InMed Pharmaceuticals Inc. announced safety and efficacy results from its Phase 2 clinical trial, called 755-201-EB (the "Phase 2 Trial"), for the treatment of symptoms related to EB. The purpose of the Phase 2 Trial was to evaluate the safety of INM-755 CBN cream, which consists of the control cream plus the active pharmaceutical ingredient CBN, and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with EB. All four subtypes of inherited EB, including EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome were accepted into the Phase 2 Trial.

The Phase 2 Trial used a within-patient, double-blind design whereby matched index areas were randomized to INM-55 CBN cream or control cream. The Phase 2 Trial enrolled a total of 19 patients. Data from one patient were excluded from efficacy analyses due to a significant protocol deviation.

Of the 18 remaining patients whose data were considered reliable for clinical review, 17 were treated for chronic non-wound itch and one patient was treated for wound-related itch. The remaining endpoints (pain, wound healing) could not be analyzed due to too few enrollees with such symptoms. Of the 18 participants assessed, chronic itch improved by a clinically meaningful amount in 12 patients (66.7%), of whom: 6 patients (33.3%) had the same level of itch improvement with INM-755 cream as with control cream; However, the protocol-specified statistical analyses for non-wound itch were not statistically significant in favor of INM-755 due in part to the clinically important anti-itch effect of the underlying control cream. As expected based on a Phase 1 safety study (755-101-HV) undertaken by the Company, systemic exposure of CBN was measured at very low concentrations (picograms/mL in plasma).

There were no serious drug-related adverse events ("AEs") and there were no withdrawals from treatment. Moderate headaches in one study participant were the only systemic AEs deemed 'possibly related' to study drug. Very few local AEs were reported in the treatment areas; they were transient and resolved without cessation of treatment.

The Phase 2 Trial indicated that INM-755 CBN cream was very well tolerated on sensitive EB skin.