Transition to INM-755 Expected to Improve the Probability of Development and Regulatory Success
Initiation of a Phase I Clinical Trial Remains On-track
VANCOUVER, March 13, 2019 /PRNewswire/ - InMed Pharmaceuticals Inc. ("InMed" or the "Company") (TSX:IN; OTCQX:IMLFF), a biopharmaceutical company developing a proprietary biosynthesis platform technology for the manufacturing of pharmaceutical-grade cannabinoids as well as a R&D pipeline of medications targeting diseases with high unmet medical needs, today provided an update on its drug development program for the treatment of Epidermolysis Bullosa ("EB").
The Company has determined that the clinical development path forward with its investigational drug candidate for the treatment of EB, previously referred to as INM-750, will be optimized by transitioning to an alternative formulation, now designated as INM-755. INM-755 is formulated based on one of the two cannabinoids that comprised INM-750.
Alexandra D.J. Mancini, MSc, InMed's Senior Vice President, Clinical and Regulatory Affairs, commented, "Our decision to move forward in clinical development with INM-755 is data-driven. Moreover, we believe that pursuing a single-agent formulation, rather than a combination product, will ultimately improve the probability of development and regulatory success in this complex and rare disease." Ms. Mancini continued, "INM-755 will be developed based on its potential to provide symptomatic benefit for all EB patients, and possibly improve skin integrity in a subset of EB Simplex patients through keratin up-regulation."
The Company remains on track to file a Clinical Trial Application with Health Canada in the second half of 2019, with the initiation of a Phase I clinical trial beginning before the end of the year.
InMed Pharmaceuticals is a 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.
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: transitioning the company's EB R&D program to an alternative formulation, INM-755; the ability of a single-agent formulation, rather than a combination product, to improve the probability of development and regulatory success; INM-755's potential to provide symptomatic benefit for all EB patients, and possibly improve skin integrity in a subset of EB Simplex patients through keratin up-regulation; filing a Clinical Trial Application with Health Canada in the second half of 2019, with the initiation of a Phase I clinical trial beginning before the end of the year; 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.
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; 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: INM-755 may not achieve the desired level of success; 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; and InMed's proprietary biosynthesis manufacturing process and drug development programs may not deliver the expected level of results. 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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