Phase 1 Trial of EB Cannabinol Cream on Track Despite COVID-19, InMed Says

InMed Pharmaceuticals does not expect that the COVID-19 pandemic to significantly affect data collection in its Phase 1 trial testing INM-755, a potential epidermolysis bullosa (EB) treatment, in healthy volunteers.

INM-755 is a topical cream, whose active ingredient is cannabinol (CBN), a compound present in trace amounts in the cannabis plant. Preclinical data suggested that INM-755 could ease EB symptoms, including inflammation, itching, and pain.

The 755-101-HV Phase 1 trial completed enrollment in early March. The trial is evaluating the safety and tolerability of INM-755, applied on the skin of 22 healthy adults daily for 14 days. It is being conducted at the Center for Health and Drug Research in the Netherlands.

Despite the ongoing COVID-19 outbreak, InMed does not expect a significant disruption in remaining dosing and in data collection as the trial is nearly finished, the company said in a press release.

A second clinical trial, 755-102-HV, plans to test two strengths of INM-755 cream on open skin wounds in eight healthy adults over 14 days. InMed has filed a request for regulatory approval to start this study at the same Netherlands test site. 

“This second Phase 1 trial represents another important step towards efficacy trials with INM-755,” Alexandra Mancini, InMed’s senior vice president of clinical and regulatory affairs, said in a separate press release.

But restrictions due to the pandemic are in place in the Netherlands, and if approval is given, this second trial won’t start recruiting volunteers until “after those restrictions are lifted,” Mancini added.

755-102-HV was scheduled to begin enrolling people in mid-May.

InMed is also continuing development of INM-088, another topical CBN formulation intended to treat glaucoma. Plans for advanced preclinical testing starting this spring remain on track, the company said, though timelines may need to be adjusted.

“In response to the outbreak of COVID-19, InMed is taking all necessary measures to ensure, first and foremost, the health and safety of our employees while also minimizing the impact to our ongoing operations,” said Eric A. Adams, InMed’s CEO. “We are committed to doing everything within our power to limit the possible negative effects on our long-term success.”

The company began implementing its Pandemic Preparedness Plan in early March, which included canceling all corporate travel, exercising social distancing in the workplace, and encouraging work from home.

“InMed’s executive team is proactively reviewing all expenditures in light of the continued uncertainty around the severity and duration of the virus spread and it is reasonable to expect some impact on our programs over time,” Adams added. “We will be in a better position to provide guidance on any changes to development timelines during the next quarterly update teleconference in May.”