The company announced the composition of its treatment candidates at the EB2020 World Congress, held recently in London.
Cannabinoids are the active chemicals that give the cannabis plant its medical and psychoactive properties. The most common are called cannabidiol or CBD, and tetrahydrocannabinol or THC. CBD is devoid of psychoactive activity and has analgesic and anti-inflammatory properties. THC is classified as a mild sedative at low doses and a hallucinogen at high doses.
CBN, meanwhile, is found only in trace quantities and may have distinct therapeutic and safety characteristics compared with CBD and THC. According to the U.S. National Library of Medicine, cannabinol has potential immunosuppressive and anti-inflammatory properties.
INM-755 is a CBN-based topical cream being developed to treat symptoms of EB and other skin conditions. It was 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. The topical application seeks to avoid potential side effects related to systemic, or whole body administration.
While primarily developed for people with EB simplex, the most common form of epidermolysis bullosa, INM-755 also is intended to address major symptoms in all patients with the genetic skin disorder.
Preclinical evidence suggested that the experimental therapy may ease inflammation, itching, and pain in people with EB.
InMed Pharmaceuticals requested approval in November 2019 to start a Phase 1 trial in the Netherlands to test INM-755 in healthy volunteers.
The randomized, double-blind trial, approved in December, is known as Study 755-101-HV. It will assess the safety and tolerability of INM-755 while also exploring the time course of its absorption, distribution, and metabolism in the body, and its excretion. The treatment will be applied daily for 14 days on the skin of 22 healthy adults.
In a second phase, this study will assess INM-755 in treating open wounds of eight healthy volunteers.
A global Phase 1/2 trial in EB patients is planned after the completion of Phase 1 studies. The company plans to file for regulatory permission to conduct this trial at the end of 2020.
“We are proud to be the first company to investigate cannabinol’s therapeutic potential in human clinical trials,” Eric A. Adams, president and CEO of InMed, said in a press release.
“InMed has completed more than 30 preclinical pharmacology and toxicology studies, identifying potential therapeutic advantages of CBN in specific disease models over the more common cannabinoids THC and CBD, as well as other rare variants,” Adams said. “We are simultaneously exploring innovative biosynthetic manufacturing methods and therapeutic applications of CBN formulations to target diseases with high unmet medical need.”
The company is developing a proprietary biosynthesis platform to economically produce pharmaceutical-grade cannabinoids at commercial scale.
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