Trial Application for Experimental Cannabinoid Epidermolysis Bullosa Treatment Gains Approval

According to a story from prnewswire.com, the biopharmaceutical company InMed Pharmaceuticals, Inc. has recently announced that that company’s Clinical Trial Application has been approved in the Netherlands. This approval will allow the company to conduct a phase 1 clinical trial that will test its investigational drug INM-755, which is a cannabinoid based skin cream that is in development to treat the rare disease epidermolysis bullosa (EB).

About Epidermolysis Bullosa

Epidermolysis bullosa is a group of genetic conditions which are most characterized by unusual blistering of the mucous membranes and skin. These painful blisters can occur with only minor friction or abrasion. The disease can be fatal in severe cases. These disorders are all caused by genetic mutations; the various subtypes of epidermolysis bullosa are classified by which genes are affected. Painful mucosal and skin blisters are the defining symptoms, but other complications may include esophageal narrowing and a vastly increased risk of skin cancer. There is no cure for the condition; treatment primarily focuses on symptom management, such as controlling pain, cleaning wounds, prevention or treatment of complications, nutritional support, and controlling infections. Males and females are affected at equal rates. The disease can seriously shorten lifespan, and in severe cases, patients do not survive beyond infancy. There is a dire need for more effective treatment approaches for epidermolysis bullosa. To learn more about these disorders, click here.

About The Trial

Phase 1 clinical trials typically do not directly test the drug in question on the target patient population. Instead, the activity of INM-755 will be monitored on healthy volunteers. Data on various characteristics of the therapy, such as pharmacokinetics, overall safety, and tolerability, will be gathered. Two different dose levels of the treatment will be tested on 22 adult participants.

InMed hopes that INM-755 will be able to provide meaningful symptom relief for epidermolysis bullosa patients, and believes that it could also help address the underlying disease mechanism in some patients by improving skin integrity via stimulating the production of certain proteins called keratins. The company also hopes that the cream will also be effective for other skin conditions.


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