Phase 2 Trial of INM-755, Cannabinol Cream for EB, Opening Soon
“The start of this Phase 2 clinical trial represents a very important step forward to test the efficacy of INM-755 (cannabinol) cream in treating epidermolysis bullosa, a disease that has very few treatment options,” Alexandra Mancini, senior vice president of clinical and regulatory affairs at InMed Pharmaceuticals, the potential therapy’s developer, said in a press release.
The Phase 2 trial (NCT04908215) will be conducted at 11 clinical sites across seven countries: Austria, Germany, Greece, France, Italy, Israel, and Serbia. An initiation visit was conducted at the site in Austria, where screening for patients is to begin, according to InMed.
Up to 20 patients, ages 12 and older, will be enrolled. The study, due to conclude in July 2022, is open to people with all four types of inherited EB — EB simplex, dystrophic EB, junctional EB, and Kindler syndrome.
Its goals are to assess the investigational cream’s safety and early evidence of efficacy in treating pain, itch, and in healing wounds over a 28-day period.
The study will use a within-patient, double-blind design, which means that each patient will have some parts of the skin treated with INM-755 and other areas receiving a vehicle (cream with no active ingredient). Comparisons will be made between the two.
The active ingredient in INM-755 is a cannabinol, a molecule derived from the cannabis plant. In preclinical studies, cannabinol was reported to reduce markers of inflammation and pain. It also increased production of a type of keratin protein, which InMed anticipates will help to improve skin integrity and ease blister formation in EB simplex patients with mutations in another keratin protein.
Data from two previous Phase 1 trials in healthy volunteers with intact skin or open wounds confirmed INM-755 was generally well-tolerated, and did not interfere with the skin’s normal healing.
“Based on our earlier studies, we are hopeful that our cannabinol cream will prove to be a safe and effective treatment for people living with this severe genetic skin disease,” Mancini said.
“The achievement of this important milestone along the continuum of pharmaceutical drug development in EB supports our belief that this class of compounds hold broad therapeutic potential,” said Eric A. Adams, president and CEO of InMed.