VANCOUVER, Nov. 5, 2019 /PRNewswire/ – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (TSX: IN;OTCQX: IMLFF), today announced the filing of a Clinical Trial Application (“CTA”) in the Netherlands to initiate a Phase 1 human clinical trial for INM-755 in healthy volunteers.

INM-755 is a single-cannabinoid topical cream under development for the treatment of symptoms associated with epidermolysis bullosa (“EB”). It may also potentially address the underlying disease by enhancing skin integrity in a subset of EB Simplex patients.

Study #755-101-HV is a randomized, double-blind, vehicle-controlled, Phase 1 study designed to evaluate the local and systemic safety, tolerability, and pharmacokinetics of INM-755 cream applied daily on intact skin in healthy volunteers. Two strengths of INM-755 cream will be evaluated in 22 adult subjects over a 14-day treatment period.

“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,” says Alexandra Mancini, Senior Vice President of Clinical and Regulatory Affairs. “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.”

“This is a significant milestone for the Company as we transition from a preclinical to a clinical stage organization,” says Eric A. Adams, CEO. “We have successfully demonstrated our ability to shepherd a novel compound through the tremendously complex process of preclinical testing and are well prepared to commence human clinical trials. With our extensive preclinical development package in hand, we are positioned to efficiently pursue additional indications for INM-755. We will also continue to develop as a clinical stage company as we advance our other product candidates, including INM-088 for glaucoma and other ocular diseases.”

About InMed:
InMed Pharmaceuticals is a biopharmaceutical company developing a proprietary biosynthesis system for the manufacturing of pharmaceutical-grade cannabinoids, as well as a pipeline of cannabinoid-based medications that target diseases with high unmet medical needs. The Company is dedicated to delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based medicines. For more information, visit www.inmedpharma.com.

About Epidermolysis Bullosa (EB). EB a collective name of a group of genetic disorders of connective tissues that affects individuals from birth and is characterized by fragile skin that is 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. In severe cases, the blisters may occur inside the body, such as the lining of the mouth or the stomach. Most types of epidermolysis bullosa are inherited. The disease has no definitive cure and all current treatments are directed towards symptoms relief.

About INM-755.  INM-755 cream is a proprietary, topical, single-cannabinoid product candidate intended as a therapy in epidermolysis bullosa (EB) and potentially other dermatological applications. It has been specifically designed with the intent to increase skin integrity in certain patients with EB Simplex (the most common form of EB) while treating the major symptoms of the disease in all patients with EB. Preclinical data demonstrate that INM-755 may have a significant impact on certain symptoms of EB (which may include reduction in pain, itch and inflammation). These disease hallmarks are key therapeutic targets for the effective treatment of EB as well as several other dermatological conditions. Additionally, our data indicate that INM-755 may have an impact on skin integrity by increasing the production of certain proteins, called keratins, in the skin.