InMed Announces Completion of Subject Treatments in Second Phase 1 Clinical Trial of INM-755 CBN Cream in Healthy Subjects
VANCOUVER, BC, Sept. 24, 2020 /PRNewswire/ - 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 second Phase 1 clinical trial with INM-755 have completed treatment. INM-755 is being developed as a topical CBN-based cream to potentially treat Epidermolysis Bullosa ("EB") as well as potentially other dermatological diseases.
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. Eight adult subjects were treated with two strengths of INM-755 cream over a 14-day treatment period. As with InMed's first Phase 1 clinical trial with INM-755, the 755-102-HV trial is being conducted at the Centre for Human Drug Research in Leiden, the Netherlands.
Despite the COVID-19 pandemic and the resulting restrictions that have affected clinical development programs worldwide, the full treatment phase of this second Phase 1 trial was achieved with only a modest delay to the original timeline. With completion of both the 755-101-HV and the 755-102-HV treatment phases, and assuming positive safety and tolerability data of INM-755 on both intact skin and epidermal wounds, the Company will be better positioned to advance detailed planning for the first efficacy trial in EB patients.
InMed anticipates reporting results from both Phase 1 trials in the second half of calendar 2020 and, assuming a positive safety profile for INM-755, submitting regulatory filings for the first efficacy trial in EB patients in early 2021.
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 CBN; the treatment of EB and other dermatological diseases by INM-755; the assumption of positive and tolerability data of INM-755 on both intact skin and epidermal wounds; the Company being in a better position to advance detailed planning for the first efficacy trial in EB patients; the anticipation of the reporting results of both Phase 1 trials in the second half of calendar 2020; submitting regulatory filings for the first efficacy trial in EB patients in early 2021; 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 to 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: positive safety and tolerability data of INM-755 on both intact skin and epidermal wounds; continued and timely positive preclinical and clinical efficacy data; the speed of regulatory approvals and reporting results; 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 and reporting results 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; existing cash reserves may not be sufficient to allow InMed to complete our forthcoming significant milestones; and 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.
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SOURCE InMed Pharmaceuticals Inc.
Company Codes: OTC-QX:IMLFF, Toronto:IN