InMed Announces Completion of Subject Treatments i
Post# of 4861
(Total Views: 226)
Posted On: 09/24/2020 8:33:10 AM
InMed Announces Completion of Subject Treatments in Second Phase 1 Clinical Trial of INM-755 CBN Cream in Healthy Subjects
Vancouver, BC – September 24, 2020 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (TSX:IN; OTCQX:IMLFF), 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 that all subjects participating in its second Phase 1 clinical trial with INM-755 have completed treatment. INM-755 is being developed as a topical CBN-based cream to potentially treat Epidermolysis Bullosa ("EB"
as well as potentially other dermatological diseases.
The 755-102-HV clinical trial is a randomized, double-blind, vehicle-controlled, Phase 1 study designed to evaluate the safety and tolerability of INM-755 cream applied daily on epidermal wounds in healthy volunteers. Eight adult subjects were treated with two strengths of INM-755 cream over a 14-day treatment period. As with InMed's first Phase 1 clinical trial with INM-755, the 755-102-HV trial is being conducted at the Centre for Human Drug Research in Leiden, the Netherlands.
Despite the COVID-19 pandemic and the resulting restrictions that have affected clinical development programs worldwide, the full treatment phase of this second Phase 1 trial was achieved with only a modest delay to the original timeline. With completion of both the 755-101-HV and the 755-102-HV treatment phases, and assuming positive safety and tolerability data of INM-755 on both intact skin and epidermal wounds, the Company will be better positioned to advance detailed planning for the first efficacy trial in EB patients.
InMed anticipates reporting results from both Phase 1 trials in the second half of calendar 2020 and, assuming a positive safety profile for INM-755, submitting regulatory filings for the first efficacy trial in EB patients in early 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/Ethan Walfish
T: +1.646.653.7030/+1.646.760.0321
E: jgreen@edisongroup.com/ewalfish@edisongroup.com
Vancouver, BC – September 24, 2020 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (TSX:IN; OTCQX:IMLFF), 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 that all subjects participating in its second Phase 1 clinical trial with INM-755 have completed treatment. INM-755 is being developed as a topical CBN-based cream to potentially treat Epidermolysis Bullosa ("EB"
as well as potentially other dermatological diseases. The 755-102-HV clinical trial is a randomized, double-blind, vehicle-controlled, Phase 1 study designed to evaluate the safety and tolerability of INM-755 cream applied daily on epidermal wounds in healthy volunteers. Eight adult subjects were treated with two strengths of INM-755 cream over a 14-day treatment period. As with InMed's first Phase 1 clinical trial with INM-755, the 755-102-HV trial is being conducted at the Centre for Human Drug Research in Leiden, the Netherlands.
Despite the COVID-19 pandemic and the resulting restrictions that have affected clinical development programs worldwide, the full treatment phase of this second Phase 1 trial was achieved with only a modest delay to the original timeline. With completion of both the 755-101-HV and the 755-102-HV treatment phases, and assuming positive safety and tolerability data of INM-755 on both intact skin and epidermal wounds, the Company will be better positioned to advance detailed planning for the first efficacy trial in EB patients.
InMed anticipates reporting results from both Phase 1 trials in the second half of calendar 2020 and, assuming a positive safety profile for INM-755, submitting regulatory filings for the first efficacy trial in EB patients in early 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/Ethan Walfish
T: +1.646.653.7030/+1.646.760.0321
E: jgreen@edisongroup.com/ewalfish@edisongroup.com
(2)
(0)