InMed Submits Clinical Trial Application to Evaluate INM-755 in Phase 1 Trial
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.
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: being able to successfully recruit healthy adult subjects and initiating a Phase 1 human clinical trial for INM-755 in healthy volunteers; INM-755 treating the symptoms of EB; INM-755 potentially enhancing skin integrity in a subset of EB Simplex patients; initiating subject screening and enrollment by year-end 2019 enabling the Company to enter the clinical phase of development; efficiently pursuing additional indications for INM-755; advancing other product candidates including INM-088; INM-755 potentially reducing pain, itch and inflammation in EB patients and increasing the production of certain proteins, called keratins, in the skin; and 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.
With respect to the forward-looking information contained in this news release, InMed has made numerous assumptions regarding, among other things: continued and timely positive preclinical and clinical efficacy data; the speed of regulatory approvals; the effectiveness of patent protection; demand for InMed's products; and continued economic and market stability. While InMed considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause InMed's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained herein. Known risk factors include, among others: the Phase 1 trial for INM-755 may not proceed with the anticipated timeline and structure, or at all; INM-755 may not produce the desired effects; InMed may not be able to advance its other product candidates, such as INM-088, on a timely basis, or at all; regulatory filings may not be filed or approved on a timely basis, or at all; clinical trials may not proceed as anticipated; economic or market conditions may worsen; InMed's proprietary biosynthesis manufacturing process and drug development programs may not deliver the expected level of results; and InMed may not be able to provide new therapeutic alternatives that benefit patients via cannabinoid-based medicines. A more complete discussion of the risks and uncertainties facing InMed is disclosed in InMed's most recent Annual Information Form and other continuous disclosure filed with Canadian securities regulatory authorities on SEDAR at www.sedar.com.
All forward-looking information herein is qualified in its entirety by this cautionary statement, and InMed disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except as required by law.
NEITHER THE TORONTO STOCK EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
SOURCE InMed Pharmaceuticals Inc.
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