InMed Receives CTA Approval for Second Phase 1 Clinical Trial with INM-755
InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (TSX: IN; OTCQX: IMLFF), a clinical-stage pharmaceutical company developing medications targeting diseases with high unmet medical need and leading the way in the clinical development of cannabinol (“CBN”), today announced it has received regulatory and ethics board approval of its Clinical Trial Application (“CTA”) to conduct its second Phase 1 trial with INM-755.
The 755-102-HV clinical trial is a randomized, double-blind, vehicle-controlled, Phase 1 study designed to evaluate the safety and tolerability of INM-755 cream applied daily on epidermal wounds in healthy volunteers. Two strengths of INM-755 cream will be evaluated in 8 adult subjects over a 14-day treatment period. INM-755 is a CBN cream intended as a topical therapy to treat epidermolysis bullosa (“EB”) and potentially other dermatological diseases.
“We are pleased with the successful CTA review process and we look forward to advancing INM-755 into this second Phase 1 trial,” commented Eric A. Adams , President and CEO of InMed Pharmaceuticals. “Despite the current constraints presented by the pandemic, our team continues to prepare for study initiation to ensure that we will be poised to commence enrollment at the earliest possible opportunity.”
The Dutch national government has announced that a few pandemic-related restrictions will be lifted soon but most restrictions will remain in place until at least May 20 th. The Centre for Human Drug Research, where the 755-102-HV trial will be conducted, is planning for the initiation of new clinical trials once permitted by the government. The Company will provide an update on the initiation of 755-102-HV when there is more certainty around timing.
About InMed: InMed Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of cannabinoid-based medications, initially focused on the therapeutic benefits of cannabinol (CBN) in diseases with high unmet medical need. 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 INM-755: INM-755 is a CBN cream intended as a topical therapy to treat epidermolysis bullosa (EB) and potentially other dermatological diseases. Preclinical data demonstrate that INM-755 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.
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:
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 cannabinol (“CBN”); 755-102-HV enabling the evaluation of the safety and tolerability of INM-755 cream; 755-102-HV being evaluated in 8 adult subjects over a 14-day treatment period; INM-755 treating epidermolysis bullosa and potentially other dermatological diseases; advancing INM-755 into the 755-102-HV trial; developing a pipeline of cannabinoid-based medications in diseases with high unmet medical need; delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based medicines; and INM-755 being able to potentially relieve EB symptoms, such as inflammation and pain, as well potentially restore the integrity of the skin in a subset of EB Simplex patients.
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 outbreak and impact of COVID-19 may worsen; the second 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.
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