VANCOUVER, March 20, 2020 /CNW/ – 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 provided an update on the impact of the global outbreak of COVID-19 on its business operations.
In early March, the Company began to implement guidelines of its Pandemic Preparedness Plan, including cancelling all corporate travel, exercising social distancing in the workplace and enabling all staff to work from home. The Company also began to interact on a more frequent basis with the numerous research vendors for all research and development programs to monitor their local situation with regards to the COVID-19 outbreak.
Eric A. Adams, CEO of InMed stated, “In response to the outbreak of COVID-19, InMed is taking all necessary measures to ensure, first and foremost, the health and safety of our employees while also minimizing the impact to our ongoing operations. We are closely monitoring all program activities with our numerous contract research organizations (“CROs”) on a daily basis. We are fortunate that our administrative, scientific and clinical teams are able to operate effectively while working remotely. We are committed to doing everything within our power to limit the possible negative effects on our long-term success.”
In regards to InMed’s INM-755 program, investigating CBN cream as a topical therapy to treat epidermolysis bullosa, the Company has been in regular communications with the Center for Health and Drug Research in the Netherlands, which is the clinical site conducting the 755-101-HV Phase 1 trial. As this trial is nearing completion, InMed does not anticipate a significant disruption in the remaining treatments and collection of data. The Company is diligently preparing for the second healthy volunteer trial, Study 755-102-HV, at the same clinical site, scheduled to begin enrollment in mid-May. The ability to initiate enrollment according to the planned timeline will be assessed at a later date.
The INM-088 program remains on track. The Company anticipates being in a position to select an appropriate delivery formulation for INM-088 in the near term and continues to make plans for advanced preclinical testing in the Spring. The timelines to execute on this study will be determined by both the choice of the delivery formulation (i.e. an internal candidate vs. an external candidate) as well as the availability of the European CRO, in line with their current policies and working status during the pandemic.
Development activities with the Company’s biosynthesis manufacturing platform have not seen any negative impacts due to the outbreak.
Adams continued, “InMed’s executive team is proactively reviewing all expenditures in light of the continued uncertainty around the severity and duration of the virus spread and it is reasonable to expect some impact on our programs over time. We will be in a better position to provide guidance on any changes to development timelines during the next quarterly update teleconference in May.”
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.
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); developing a pipeline of cannabinoid-based medications in diseases with high unmet medical need; ensuring the health and safety of our employees; being able to minimize the impact of COVID-19 on our operations; anticipating no significant disruption in the remaining treatments and collection of data the 755-101-HV phase 1 trial; the potential for some impact on our programs due to the outbreak of COVID-19; limiting possible negative effects on the Company’s long-term success due to the outbreak of COVID-19; being able to begin enrollment of the Study 755-102-HV trial in mid-May; being in a position to select an appropriate delivery formulation for INM-088 in the near term; commencing advanced preclinical testing of INM-088 in the Spring; being in a better position to provide guidance on any changes to development timelines during the next quarterly update teleconference in May; INM-755’s ability to treat epidermolysis bullosa (EB) and potentially other dermatological diseases; 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 http://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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