InMed starts phase 2 trial for EB
InMed Pharmaceuticals Inc, a leader in the manufacture and clinical development of rare cannabinoids, has initiated its Phase 2 clinical trial of INM-755 (cannabinol) cream for the treatment of Epidermolysis bullosa. This is the first time cannabinol has entered a Phase 2 clinical trial to be evaluated as a therapeutic option for the treatment of a disease.
This trial is being conducted at eleven sites in seven countries, including Austria, Germany, Greece, France, Italy, Israel and Serbia. Clinical trial applications have been submitted in all participating countries and regulatory and ethics committee approvals are currently pending in four countries (Austria, France, Greece, Israel). The first enrolment visit has been completed at a clinical site in the EB House Austria, where screening of eligible patients will begin shortly.
INM-755 is a cannabinol (CBN) cream intended as a topical therapy for the treatment of EB and potentially other dermatological conditions. Preclinical data show that INM-755 (cannabinol) cream can help relieve typical EB symptoms such as inflammation and pain, and potentially also restore skin integrity in a subset of EB simplex patients. Phase 1 data in healthy volunteers have shown that INM-755 (cannabinol) cream is well tolerated on both normal, intact skin and open wounds and does not cause a delay in wound healing.
Study 755-201-EB will enrol up to 20 patients, conservatively within 12 months. All four subtypes of inherited EB, i.e. EB Simplex, Dystrophic EB, Junctional EB and Kindler Syndrome, are eligible for this study, in which InMed will evaluate the safety of INM-755 (cannabinol) cream and its preliminary efficacy in treating symptoms and wound healing over a 28-day period. The study will use a within-patient, double-blind design in which matched index areas will be randomly assigned to INM-755 (cannabinol) cream or vehicle cream as a control.