InMed Pharmaceuticals Submits Clinical Trial Applications to Evaluate INM-755 (Cannabinol) Cream in a Phase 2 Trial for Epidermolysis Bullosa
- Filings submitted in
Austria, Israel, and Serbiafor a Phase 2 Clinical Trial with INM-755 cream
- Additional submissions slated for
France, Germany, Greece, and Italyover the next several days and weeks.
- Anticipated study on track to begin in 3Q 2021
Responses from the NCAs and ECs are expected throughout July and
“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,” stated
The ‘201 study is designed to enroll up to 20 patients, conservatively within 10-12 months, and will take place at 10 pre-qualified clinical sites in the above-mentioned countries. All four subtypes of inherited EB, being EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome, are eligible for this study in which InMed will evaluate the safety of INM-755 (cannabinol) cream and its preliminary efficacy in treating symptoms and healing wounds over a 28-day period. The study will use a within-patient, double-blind design whereby matched index areas will be randomized to INM-755 (cannabinol) cream or vehicle cream as a control.
Filing CTAs in these countries to the NCAs serve the same purpose as filing Investigational New Drug (“IND”) Applications to the
About INM-755: INM-755 is a cannabinol (CBN) cream intended as a topical therapy to treat epidermolysis bullosa (EB) and potentially other dermatological diseases. Preclinical data demonstrate that INM-755 (cannabinol) cream may help relieve hallmark EB symptoms, such as inflammation and pain, as well potentially restore the integrity of the skin in a subset of EB Simplex patients. Phase 1 data in healthy volunteers demonstrated INM-755 (cannabinol) cream to be well-tolerated on both normal, intact skin as well as on open wounds and caused no delay in wound healing.
About Epidermolysis Bullosa (EB): EB is the collective name of a group of genetic disorders of characterized by fragile skin and mucous membranes that are easily damaged, leading to extensive blistering and wounding. The blisters may appear in response to minor injury, even from heat, rubbing, scratching or adhesive tape. The disease has no approved cure and most current treatments are directed towards symptomatic relief.
Cautionary Note Regarding Forward-Looking Information:
Cautionary Note Regarding Forward-Looking Information: This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking information") within the meaning of applicable securities laws. Forward-looking information is based on management's current expectations and beliefs and is subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Forward-looking information in this news release includes statements about: leading the way in the clinical development of CBN; the potential for INM-755 cream to provide help for EB patients; the submission of additional clinical trial applications in
Source: InMed Pharmaceuticals Inc.