InMed Pharmaceuticals has enroled the first adolescent subject into the Phase II 755-201-EB trial of its investigational drug, INM-755 cannabinol (CBN) cream, to treat epidermolysis bullosa (EB) patients. Also, the trial had concluded treatment at a study centre in Greece.
The move comes after an independent Data Monitoring Committee (DMC) noted that it is safe to enrol adolescent EB patients of the age 12 to 17 years after reviewing the safety findings of the first five adults who completed the trial.
The within-patient, double-blind trial, analysing INM-755 CBN cream to treat EB, is designed to enrol up to 20 subjects.
Subjects with all four inherited EB subtypes, EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome will be part of the trial.
The trial will assess the safety of INM-755 CBN cream as well as its initial efficacy to treat symptoms and heal wounds over 28 days.
In December last year, the first adult patient was enrolled and nine subjects were enrolled in the trial so far.
To date, eight trial sites were activated to screen and enrol subjects into this Phase II study.
The trial is currently taking place in Austria, Germany, Greece, France, Italy, Israel and Spain.
The company intends to launch two more study centres soon.
INMED Clinical and Regulatory Affairs senior vice-president Alexandra Mancini said: “We are pleased that the initial safety data from InMed’s Phase II EB clinical trial has allowed the inclusion of adolescent patients.
“With the inclusion of adolescents and increased number of patients available for screening, the target remains to complete enrolment of 20 patients in 2022.”
In January 2020, the company announced that INM-755 is being evaluated in a Phase I trial to treat EB.