InMed Announces Completion of Initial Phase 1 Clinical Trial of INM-755 CBN Cream in Healthy Subjects
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 that all subjects participating in its 755-101-HV Phase 1 clinical trial have completed treatment and clinical evaluation.
Study 755-101-HV is a randomized, vehicle controlled, double-blind, Phase 1 trial, examining the safety and tolerability of two strengths of INM-755 cream in 22 healthy adult volunteers over a 14-day treatment period. With treatment completed, InMed continues to anticipate reporting final study results in the second half of calendar 2020.
“The end of the treatment phase is an exciting milestone and we now progress into sample analysis and data review,” said Alexandra Mancini , Senior Vice President of Clinical and Regulatory Affairs. “The interim safety analysis of the blinded data from the first 16 subjects who had completed at least one week of treatment in this trial supported moving forward with activities to launch a second Phase 1 trial.” The Clinical Trial Application (“CTA”) for InMed’s second Phase 1 study with INM-755, Study 755-102-HV, was filed March 23, 2020 .
Some aspects of biological sample and data analyses will be delayed by COVID-19 pandemic-related restrictions and will impact the timing of announcing final study results. InMed is continually reviewing timelines, given current work restrictions in the Netherlands where our Phase 1 studies are being conducted. Changes to INM-755 program timelines, including enrollment in the 755-102-HV trial and the subsequent timing of regulatory filings in preparation for an initial EB patient trial, will be communicated as the Company gains additional information.
In addition, InMed President and CEO Eric A. Adams added, “We want to reassure our stakeholders that our clinical studies and subsequent sample analyses are conducted outside of the hospital setting, and, therefore, do not compete for the critical resources and medical staff needed to address this pandemic. We also continue to take all possible and responsible measures to protect our staff and minimize business disruption.”
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); reporting final 755-101-HV results in the second half of calendar 2020; progressing into 755-101-HV sample analysis and data review; moving forward with activities to launch 755-102-HV, the second Phase 1 trial; COVID-19 pandemic-related restrictions impacting on timing of clinical related activities including biological sample and data analyses, enrollment in the 755-102-HV trial and regulatory filings; ensuring the health and safety of our employees; being able to minimize the impact of COVID-19 on our operations; INM-755 treating epidermolysis bullosa (EB); 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 IMN-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: continued and timely positive preclinical and clinical efficacy data; the speed of regulatory approvals; the ability to contract with suitable partners; 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; preclinical and clinical testing may not produce the desired results on a timely basis, or at all; regulatory applications may not be approved on a timely basis, or at all; cannabis licensing/importing issues may delay our projected development timelines; suitable partners may not be located; economic or market conditions may worsen; our existing cash runway may not allow us to complete our forthcoming significant milestones; the development of a proprietary biosynthesis manufacturing technology for the production of pharmaceutical-grade cannabinoids as well as a pipeline of medications targeting diseases with high unmet medical need may not be as successful as desired, if at all. 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.
SOURCE InMed Pharmaceuticals Inc.
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