Pending approval, the company plans to enroll patients until the end of the year.
INM-755 is a topical cream being developed to treat symptoms associated with EB and other skin conditions. It is a cannabinoid-based therapy (derived from the cannabis plant) designed to increase skin integrity by boosting the levels of keratin, a key structural protein in the outer layers of the skin, hair, and nails.
While primarily developed for people with EB simplex (the most common form of EB), INM-755 is also intended to address major symptoms in all patients with EB.
Preclinical studies suggested that the experimental therapy may ease inflammation, itching, and pain in EB patients.
The proposed randomized, double-blind Phase 1 trial, known as study #755-101-HV, will assess the safety and tolerability of INM-755. Scientists will also explore the time course of its absorption, distribution, metabolism, and excretion in the body. The treatment will be applied daily for 14 days on the skin of 22 healthy adults.
For InMed’s application to start the trial, the trial’s sponsor must provide information about the investigational therapy and the study protocol. Experts then analyze the treatment’s properties, the benefit/risk ratio of the study, the quality of the information provided to participants, as well as the suitability of clinical sites and investigators.
“This filing follows the successful conclusion of an extensive preclinical development program that included 20 safety pharmacology and toxicology studies with treatment up to 28 days,” Alexandra Mancini, InMed’s senior vice president of clinical and regulatory affairs, said in a press release.
“We are very pleased with the preclinical data package, which further validates our scientific rationale and approach to treat EB, and look forward to starting the clinical phase of development and initiating subject screening and enrollment by year-end 2019,” Mancini added.
Eric A. Adams, president and CEO of InMed, said: “This is a significant milestone for the company as we transition from a preclinical to a clinical stage organization.”
He also said that the company is “positioned to efficiently pursue additional indications for INM-755.”