Phase 1 Trial of EB Cannabinol Cream Completes Treatment in Healthy Volunteers

All healthy volunteers participating in InMed Pharmaceuticals’ Phase 1 trial of INM-755, an investigational cannabinol cream for epidermolysis bullosa (EB), have completed treatment and clinical evaluation.

InMed expects to report final results of the trial, which was conducted in The Netherlands, later this year.

The announcement came after the company recently announced it did not expect the COVID-19 outbreak would impair the study’s dosing and data collection. However, some aspects of the data analyses will be delayed by the pandemic, which may also postpone the announcement of final results.

“The end of the treatment phase is an exciting milestone and we now progress into sample analysis and data review,” Alexandra Mancini, senior vice president of clinical and regulatory affairs at InMed, said in a press release.

INM-755 is a topical cream that contains cannabinol (CBN) — a natural compound found in small amounts in the cannabis plant. It is currently being investigated as a potential treatment to ease the symptoms of EB and other skin disorders.

The Phase 1 trial, called 755-101-HV, is assessing the safety, tolerability, and pharmacological properties of INM-755 in a group of 22 healthy volunteers. Participants were treated with two strengths of the INM-755 cream, which was applied to the skin every day for a period of 14 days.

In the meantime, InMed has filed a clinical trial application for a second Phase 1 trial of INM-755, called 755-102-HV, based on promising early data from the first trial. This second trial aims to investigate the safety of two strengths of the INM-755 cream when applied directly on open wounds.

“The interim safety analysis of the blinded data from the first 16 subjects who had completed at least one week of treatment in [the first] trial supported moving forward with activities to launch a second Phase 1 trial,” Mancini said.

Any enrollment delays in the upcoming trial, as well as in current regulatory processes related to a future trial of INM-755 in EB patients, will be announced as soon as more information becomes available, the company said.

“We want to reassure our stakeholders that our clinical studies and subsequent sample analyses are conducted outside of the hospital setting, and, therefore, do not compete for the critical resources and medical staff needed to address this pandemic,” Eric A. Adams, CEO of InMed, said. “We also continue to take all possible and responsible measures to protect our staff and minimize business disruption.”