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.
About InMed: InMed Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of cannabinoid-based medications, initially focused on the therapeutic benefits of cannabinol (CBN) in diseases with high unmet medical need. The Company is dedicated to delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based medicines. For more information, visit www.inmedpharma.com.
About INM-755: INM-755 is a CBN cream intended as a topical therapy to treat epidermolysis bullosa (EB) and potentially other dermatological diseases. Preclinical data demonstrate that INM-755 may help relieve hallmark EB symptoms, such as inflammation and pain, as well potentially restore the integrity of the skin in a subset of EB Simplex patients.
About Epidermolysis Bullosa (EB): EB is the collective name of a group of genetic disorders of characterized by fragile skin and mucous membranes that are easily damaged, leading to extensive blistering and wounding. The blisters may appear in response to minor injury, even from heat, rubbing, scratching or adhesive tape. The disease has no approved cure and most current treatments are directed towards symptomatic relief.
Investor Contact:
InMed Pharmaceuticals Inc.
Brendan Payne, Director – Investor Relations
T: +1.604.669.7207
E: info@inmedpharma.com
Edison Advisors for InMed Pharmaceuticals
Joe Green/Laine Yonker
T: +1.646.653.7030/+1.646.760.0321
E: jgreen@edisongroup.com / lyonker@edisongroup.com