Good Morning All! Hey, look at this, some people can get clinical trials done and produce actual products --- who knew.
InMed Announces Results of Initial Phase 1 Clinical Trial of INM-755 CBN Cream in Healthy Subjects
Vancouver, BC – November 25, 2020 – 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”).
Results 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.
Study 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.
Study 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.
Local 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).
Comparison 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.
The 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 stinging/burning in some subjects from the vehicle group suggests that the administered vehicle and/or the film dressing may have contributed to observed local reactions across all study groups. Contact dermatitis is commonly seen with film dressings like those used in this study and by EB patients.
A very low amount of drug was measured in the blood of subjects who received the high-concentration INM-755 cream. CBN levels were too low to be measured in most subjects in the low-concentration INM-755 group. No systemic adverse effects were caused by INM-755 exposure in this study. Systemic safety was evaluated by standard procedures that included reporting adverse events, use of concomitant medications, findings from physical examinations, electrocardiograms, measurements of vital signs, and the full set of hematology, chemistry, and urinalysis laboratory parameters.
Additionally, Study 101 assessed subject-reported outcomes for alertness, calmness, and mood using the Bond-Lader Visual Analogue Scale, and internal perception, external perception, and “feeling high” using the Bowdle Visual Analogue Scale. Treatment of 5% BSA daily for 14 days with INM-755 cream did not cause any effects on these subject-reported feelings.
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 which did not lead to any systemic adverse effects. Study 101 is the first of two Phase 1 clinical trials conducted in healthy volunteers. The second, 755-102-HV Phase 1 trial (“Study 102”), which recently completed subject treatment, is investigating the effect of INM-755 cream on small epidermal wounds. The Company anticipates reporting the results from Study 102 in early first quarter of calendar 2021.
Source: info@inmedpharma.com
InMed Announces Results of Initial Phase 1 Clinical Trial of INM-755 CBN Cream in Healthy Subjects
Vancouver, BC – November 25, 2020 – 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”).
Results 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.
Study 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.
Study 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.
Local 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).
Comparison 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.
The 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 stinging/burning in some subjects from the vehicle group suggests that the administered vehicle and/or the film dressing may have contributed to observed local reactions across all study groups. Contact dermatitis is commonly seen with film dressings like those used in this study and by EB patients.
A very low amount of drug was measured in the blood of subjects who received the high-concentration INM-755 cream. CBN levels were too low to be measured in most subjects in the low-concentration INM-755 group. No systemic adverse effects were caused by INM-755 exposure in this study. Systemic safety was evaluated by standard procedures that included reporting adverse events, use of concomitant medications, findings from physical examinations, electrocardiograms, measurements of vital signs, and the full set of hematology, chemistry, and urinalysis laboratory parameters.
Additionally, Study 101 assessed subject-reported outcomes for alertness, calmness, and mood using the Bond-Lader Visual Analogue Scale, and internal perception, external perception, and “feeling high” using the Bowdle Visual Analogue Scale. Treatment of 5% BSA daily for 14 days with INM-755 cream did not cause any effects on these subject-reported feelings.
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 which did not lead to any systemic adverse effects. Study 101 is the first of two Phase 1 clinical trials conducted in healthy volunteers. The second, 755-102-HV Phase 1 trial (“Study 102”), which recently completed subject treatment, is investigating the effect of INM-755 cream on small epidermal wounds. The Company anticipates reporting the results from Study 102 in early first quarter of calendar 2021.
Source: info@inmedpharma.com
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