Transition to INM-755 Expected to Improve the
Probability of Development and Regulatory Success
Initiation of a Phase I Clinical Trial Remains
On-track
TSX:IN
OTCQX:IMLFF
VANCOUVER, March 13, 2019 /CNW/ - 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.
About InMed:
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.
NEITHER THE TORONTO
STOCK EXCHANGE NOR ITS REGULATIONS
SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE
ADEQUACY OR ACCURACY OF THIS RELEASE.
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SOURCE InMed Pharmaceuticals Inc.