InMed Pharmaceuticals Inc. (NASDAQ:INM) provided an update on its phase 2 clinical trial using investigational drug INM-755 cannabinol (“CBN”) cream for the treatment of patients with epidermolysis bullosa (“EB”).
Adolescent patients now eligible to participate in clinical trial
Based on the safety data of the first five adult patients who completed the phase 2 study, an independent data monitoring committee agreed it is safe to allow the enrollment of adolescent patients with EB, defined as persons aged twelve to seventeen, into InMed’s Phase 2 clinical trial evaluating INM-755 CBN cream for the treatment of EB. The first adult patient was enrolled in December 2021 and, to date, nine patients have been enrolled in the study.
First adolescent patient enrolled into clinical trial
With the data monitoring committee approval to enroll adolescent patients into InMed’s INM-755 phase 2 clinical trial, the first adolescent patient with EB has been enrolled into the clinical trial and has completed treatment at the clinical site in Greece.
Patent granted in Japan
InMed has recently been granted a patent for the use of CBN in the treatment of EB in Japan. This patent allows for the use of topically administered CBN in patients with epidermolysis bullosa simplex (EBS). The company’s overall patent strategy is to continue to prosecute patent applications in other jurisdictions including Europe and the United States.
Eight clinical trial sites fully activated
InMed’s phase 2 clinical trial now has eight clinical trial sites fully activated to screen and enroll patients. Two more sites are expected to be fully activated soon. The clinical trial is taking place in seven countries including Austria, Germany, Greece, France, Italy, Israel and Spain. The planned clinical site in Serbia will not be participating in the study due to staffing capacity issues related to the ongoing impact of the COVID-19 virus.
“We are pleased that the initial safety data from InMed’s phase 2 EB clinical trial has allowed the inclusion of adolescent patients,” stated Alexandra Mancini, senior vice president of clinical and regulatory affairs at InMed. “With the inclusion of adolescents and increased number of patients available for screening, the target remains to complete enrollment of 20 patients in 2022.”
The phase 2 study, 755-201-EB, is designed to enroll up to 20 patients. All four subtypes of inherited EB, being EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome, are eligible for this study. InMed will evaluate the safety of INM-755 (cannabinol) cream and its preliminary efficacy in treating symptoms and healing wounds over a 28-day period. The study uses a within-patient, double-blind design whereby matched index areas will be randomized to INM-755 (cannabinol) cream or vehicle cream as a control.
What is epidermolysis bullosa?
Epidermolysis bullosa, or EB, is a group of rare genetic skin diseases characterized by fragile skin that can lead to extensive blistering and wounding. It affects skin and mucous membranes, particularly of the gastrointestinal tract, genitourinary and respiratory systems. It is a debilitating disease affecting a small number of people, thus earning it an orphan-disease status. The disease has no definitive cure and all currently approved treatments are directed towards symptom relief.
Photo by Esteban Lopez on Unsplash
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