InMed Receives Clinical Trial Application Approval for INM-755, a Rare Cannabinoid Formulation Under Development for the Treatment of Epidermolysis Bullosa
VANCOUVER, Dec. 9, 2019 /PRNewswire/ - InMed Pharmaceuticals Inc. ("InMed" or the "Company") (TSX: IN; OTCQX: IMLFF), a clinical stage biopharmaceutical company developing cannabinoid-based medications targeting diseases with high unmet medical needs, today announced it has received regulatory and ethics board approval of its Clinical Trial Application ("CTA") to conduct a Phase 1 trial in the Netherlands for INM-755, a cannabinoid-based topical cream. The Company intends to initiate subject recruitment immediately.
The initial clinical trial, 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 applied daily on intact skin in healthy volunteers. Two strengths of INM-755 cream, plus vehicle-only, will be evaluated in 22 adult subjects over a 14-day treatment period.
INM-755, the Company's lead product candidate, is a single-cannabinoid topical cream under development for the treatment of symptoms associated with epidermolysis bullosa ("EB"), a rare genetic skin disease characterized by fragile skin that can lead to extensive blistering and wounding. It may also address the underlying disease by enhancing skin integrity in a subset of EB patients.
"INM-755 is the first rare cannabinoid formulation for the treatment and symptomatic relief of EB to advance to clinical trials," commented Eric A. Adams, President and CEO of InMed Pharmaceuticals. "Initiating this Phase 1 trial of INM-755 was one of our key corporate objectives for 2019. It represents a significant step in bringing forward a potential new treatment option for EB patients who are in significant need of new and more effective treatment options. The extensive preclinical safety, toxicology, and chemistry, manufacturing and controls (CMC) data included in the CTA is reflective of the strength of our development program and the Company's team."
InMed Pharmaceuticals is a clinical stage 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 is the collective name of a group of genetic disorders of connective tissues affecting 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. The disease has no definitive cure and all current treatments are directed towards symptom relief.
About INM-755. INM-755 is a proprietary, topical, single-cannabinoid cream product candidate intended as a therapy in epidermolysis bullosa (EB) and potentially other dermatological indications. It has been specifically designed with the intent of increasing skin integrity in certain EB Simplex patients (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, but is not limited to, statements about: immediately initiating subject recruitment for the 755-101-HV clinical trial; evaluating 22 adult healthy volunteers with two strengths; INM-755 potentially being able to successfully treat symptoms, including reduction in pain, itch and inflammation, associated with all EB patients; INM-755 potentially enhancing skin integrity in a subset of EB Simplex patients by increasing the production of certain proteins, called keratins, in the skin; INM-755 potentially being an effective treatment for dermatological indications other than EB; 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; and delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based medicines.
With respect to the forward-looking information contained in this news release, InMed has made numerous assumptions regarding, among other things: the ability to recruit appropriate test subjects; 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 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.
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SOURCE InMed Pharmaceuticals Inc.