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InMed Announces Results of Initial Phase 1 Clinical Trial of INM-755 CBN Cream in Healthy Subjects
VANCOUVER, BC, Nov. 25, 2020 /PRNewswire/ - InMed Pharmaceuticals Inc. ("InMed" or the "Company") (NASDAQ: INM) (TSX: IN), a clinical-stage pharmaceutical
About this update from Inmed Pharmaceuticals Inc.
[{"type":"text","content":"VANCOUVER, BC, Nov. 25, 2020 /PRNewswire/ - InMed Pharmaceuticals Inc. (\"InMed\" or the \"Company\") (NASDAQ: INM) (TSX: IN), a clinical-stage pharmaceutical company developing medications targeting diseases with high unmet medical need and leading the way in the clinical development of cannabinol (\"CBN\"), today announced top-line results from its 755-101-HV Phase 1 clinical trial (\"Study 101\"). \nResults of Study 101 indicate that INM-755 was safe and well-tolerated on intact skin, caused no systemic or serious adverse effects, and there were no subject withdrawals due to adverse events. Drug concentrations in the blood were very low, as expected.\nStudy 101 was a randomized, vehicle-controlled, double-blind, Phase 1 trial, that examined the safety and tolerability of two strengths of INM-755 cream on intact skin in 22 healthy adult volunteers over a 14-day treatment period. \nStudy 101 compared two strengths of INM-755 cream with a vehicle (cream base without CBN) under treatment procedures designed to create intense conditions for assessing skin irritation potential. The entire upper back of each subject, representing 5% body surface area (\"BSA\"), had cream applied and was then covered with a film dressing (bandage). This application was repeated daily, resulting in continuous exposure to the cream and the dressing for 14 days. These treatment conditions simulate what occurs for some EB patients who have large areas of skin covered with such a dressing daily. \nLocal tolerability was assessed daily in a standardized way for erythema (redness), edema (fluid accumulation/swelling), scaling (flaking skin), and stinging/burning. These assessments were made by trained clinic personnel who were blinded as to which treatment the patient was assigned (active versus vehicle only).\nComparison of the active and vehicle treatment groups demonstrated a slightly higher incidence and intensity of erythema and scaling in the INM-755 groups. These effects were not dose-dependent, with both the high and low-concentration INM-755 groups showing similar results. \nThe majority of subjects in all groups had no events for the four monitored local tolerability parameters on most days over the treatment period. Local reactions that did occur were mostly mild or moderate and resolved without intervention. The occurrence of mild erythema and s...