InMed Pharmaceuticals (IN.T) has filed clinical trial applications (CTAs) in Austria, Israel and Serbia as part of a phase 2 clinical trial of INM-755, the Company’s cannabinol cream used to treat epidermolysis bullosa (EB). Additionally, CTAs for 755-201-EB (201 study) will be submitted to national competent authorities (NCAs) and ethics committees (ECs) in France, Germany, Greece and Italy in the coming weeks.
“It is very exciting to be taking this important next step to test the efficacy of our cannabinol cream in EB patients. We are optimistic, based on our preclinical studies, that INM-755 cream may provide some much-needed help for these patients…Once we receive the necessary approvals, patient enrolment will begin as soon as possible, with results expected in the second half of 2022,” stated Alexandra Mancini, senior vice-president of clinical and regulatory affairs at Inmed.
There’s a lot to unpack from just the introduction, however, lets start with epidermolysis bullosa (EB). EB refers to a group of rare diseases that cause fragile, blistering skin according to Mayo Clinic. Blisters can appear in response to a variety of events like minor injuries, rubbing, scratching, and even heat. Although the prevalence of EB simplex, the most common form of EB, is estimated to affect 1 in 30,000 to 50,000 people, the condition itself is excruciatingly painful and can completely change an individual’s life. For those living with EB, their skin has to be checked daily for new blisters which can take several hours per day. Furthermore, head to foot bandaging is required to protect undamaged skin and dress blistered areas.
With this in mind, InMed’s INM-755 cannabinol cream is intended as a topical therapy to treat EB and potentially other dermatological diseases. Preclinical data has demonstrated the efficacy of INM-755 in relieving various EB symptoms including inflammation and pain. Moreover, INM-755 has shown potential in restoring the integrity of skin in a subset of EB patients. Phase 1 clinical data of INM-755 suggests that the cannabinol cream was well tolerated on both intact skin and open wounds and caused no delay in the healing process. The 201 study will enroll up to 20 patients and test the effectiveness of INM-755 in treating wounds induced by the various subtypes of inherited EB over a 28-day period.
Filing CTAs to the NCAs in these countries can be compared to filing investigational new drug applications to the US Food and Drug Administration. InMed’s application for phase 2 clinical trials of INM-755 represents a huge milestone for the Company. InMed’s cannabinol cream has already produced results and has shown promise as a potential treatment for the crippling symptoms of EB.
InMed’s share price opened at $4.10, up from a previous close of $4.06. The Company’s share price is currently up 9.85% and is trading at $4.46 following the news. This indicated that there has been significant change following the news.