Phase 2 trial of cannabinol cream INM-755 is fully enrolled
Treatment will be tested on 19 patients over 28 days; data expected in summer
InMed Pharmaceuticals has completed enrollment for a Phase 2 trial testing INM-755, an investigational cannabinol cream, for people with epidermolysis bullosa (EB).
“We look forward to the data read-out in the summer, so we can evaluate our strategic options and next steps,” Eric A. Adams, InMed’s president and CEO, said in a press release.
A total of 19 patients, 12 and older, with any of the four inherited EB subtypes — EB simplex, dystrophic EB, junctional EB, and Kindler syndrome — have been enrolled.
“We are delighted to have enrolled 19 patients in InMed’s Phase 2 clinical trial of INM-755 cannabinol cream for EB, a rare disease that has major unmet medical needs,” said Alexandra Mancini, senior vice president of clinical and regulatory affairs at InMed.
Cream’s effects on wounds will be based on patient reports, digital photography
Enrollment completion followed the approval to open the study to adolescents by an independent data monitoring committee, after INM-755 was deemed safe in five adults enrolled in the trial.
“Enrollment completion of this Phase 2 clinical trial of a cannabinol formulation represents an important milestone for InMed and the scientific community studying rare cannabinoids,” Adams said.
The Phase 2 INM-755-201-EB study (NCT04908215) is testing the safety and preliminary efficacy of INM-755, given over 28 days. Each patient will have parts of their skin, which can be wounded or non-wounded areas, randomly assigned to INM-755 or a cream with no active ingredient. Treatment will be administered every 1 to 3 days for wounded areas and daily on non-wounded areas. Comparisons will be made between INM-755 and the control cream in each patient.
The therapy’s efficacy will be evaluated based on patient-reported outcomes and wound healing measured by digital photography.
The active ingredient in INM-755 is a cannabinol, a molecule derived from the cannabis plant. This is the first Phase 2 trial of a cannabinol formulation for any disease, according to InMed.
“As a class of compounds, we believe cannabinoids hold tremendous therapeutic potential for their innate interaction with the body, however, to date there have been limited evidence-based studies investigating their effects,” Adams said.
“Taking a rare cannabinoid formulation through several Ph 1 [Phase 1] and Ph 2 [Phase 2] clinical trials has been a major undertaking,” he added.
In preclinical studies, treatment with INM-755 lessened inflammation and pain markers, and triggered the production of a keratin protein (a structural protein) known as K15. Data from two Phase 1 trials in healthy volunteers showed treatment for two weeks was generally well-tolerated, with no negative impact on skin healing.
“We are hopeful results from this Phase 2 study will provide an indication that INM-755 [cannabinol] cream may provide symptomatic relief for EB patients,” Mancini said. “I would personally like to thank all the medical staff at the various sites and our clinical research organization who worked diligently to maximize enrollment, especially considering the challenges of enrolling patients with this extremely rare disease.”