VANCOUVER, May 27, 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 preclinical results from its
INM-088 drug development program that indicate a potential
neuroprotective effect of cannabinol ("CBN") on nerve cells located
in the eye. INM-088 is being developed as a potential treatment
option for ocular diseases, such as glaucoma, where neuroprotection
may provide an added therapeutic benefit.
The first in vitro preclinical study evaluated the
neuroprotective effects of several individual cannabinoids,
including CBN, tetrahydrocannabinol ("THC") and cannabidiol
("CBD"), on differentiated retinal ganglion cells, or "RGCs", that
form a thin layer of neurons responsible for relaying visual
signals in the eye. This particular study examined the effects of
cannabinoids on RGCs under normal atmospheric pressure and elevated
pressure conditions as a model of raised intraocular pressure
("IOP"), a key characteristic of glaucoma. Elevated pressure
mimicking high IOP had a cytotoxic effect on the RGCs. However, the
combination of CBN and elevated pressure, within the same time
period, resulted in a high level of cell survival in a dose
dependent fashion. CBN was superior to both CBD and THC under
identical testing conditions. This data indicates a potential
neuroprotective effect of CBN in ocular disease.
Next, using the same in vitro model described above,
InMed examined the potential effect of CBN on reducing or
preventing natural RGC cell death, or apoptosis. Data indicate that
CBN has a significant anti-apoptotic effect on differentiated RGCs
subjected to elevated pressure conditions. Exposure of RGC to high
pressure for a period of 6 hours led to apoptosis ranging from
30-60%, whereas the addition of CBN resulted in a significantly
higher level of cell survival.
Elevated IOP in glaucoma is often attributed to decreased
aqueous humor outflow through the trabecular meshwork ("TM") of the
eye. Additionally, the cytokine TGF-β2 has been found to be
aberrantly elevated in correlation with increased TM outflow
resistance. Therefore, the Company evaluated CBN exposure to
primary TM cells under these simulated glaucoma condition through
either increased pressure conditions or by elevating TGF-β2. TM
cells exposed to CBN under a range of conditions, including normal
pressure or elevated pressure or TGF-β2 exposure, for a duration of
72 hours, demonstrated deceased expression of protein markers
associated with reduced TM outflow. These results suggest that CBN
may have potential to reduce IOP through improvement in the aqueous
humor outflow in the TM.
InMed also conducted several in vivo experiments to
understand the pharmacokinetics and effect of CBN in the eye. The
first of these studies was designed to specifically measure CBN
levels in the eye and plasma following direct bilateral
intravitreal ("IVT") injection into the fluid of the central cavity
of the eye. Following IVT delivery, systemic plasma levels of CBN
were found to be below detectable limits, whereas CBN levels in the
eye were shown to persist for an extended period of time with a
projected half-life (t1/2) of approximately 33 hrs.
These results present the prospect of high CBN localization at the
site of intended treatment.
In addition, InMed conducted an in vivo efficacy study to
evaluate neuroprotective and IOP lowering effects of CBN following
IVT injection in the recognized episcleral vein laser
photocoagulation model for glaucoma. Biological function of
the neurons was assessed through pattern electroretinogram ("pERG")
measurement of neuronal electrical activity in response to light.
Results demonstrated reduced IOP and improvement of pERG function
when CBN was delivered by IVT injection after episcleral laser
photocoagulation.
"Results from these preclinical in vitro and in
vivo studies, which also served as the basis for our recently
filed PCT patent application, highlight the potential for CBN to
contribute an independent neuroprotective effect in addition to the
standard IOP reduction approach to treating glaucoma," remarked Dr.
Eric Hsu, InMed's Senior Vice
President of Preclinical Research and Development. "We are now well
positioned to advance towards selection of a suitable topical
formulation for CBN delivery to the eye and anticipate commencing
IND-enabling toxicology studies with INM-088 in the latter half of
2020".
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-088: InMed is developing INM-088 as a
cannabinol (CBN) eye drop formulation targeting reduction of the
intraocular pressure associated with glaucoma as well as being
designed to serve as a neuroprotectant to the retinal ganglion
cells (RGC) and the optic nerve.
About Glaucoma: Glaucoma is a group of eye
conditions characterized by abnormally high pressure in the eye,
which can damage the membranes of the retina and the head of the
optic nerve, leading to blindness. Glaucoma is the second leading
cause of blindness worldwide and can occur at any age but is more
common in older adults. As of 2010, there were 44.7 million people
in the world with 'open angle' glaucoma, the most common form of
the disease, of which 2.8 million were in the United States. By the end of 2020, the
prevalence is projected to increase to 80 million worldwide with
3.4 million the United States.
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, but is not limited to, statements about: leading the way
in the clinical development of cannabinol ("CBN"); that INM-088 may
have a potential neuroprotective effect of cannabinol ("CBN") on
nerve cells located in the eye; that INM-088 may be a potential
treatment option for ocular diseases, such as glaucoma, where
neuroprotection may provide an added therapeutic benefit; CBN
having a significant anti-apoptotic effect on differentiated RGCs
subjected to elevated pressure conditions; that CBN may have
the potential to reduce intraocular pressure ("IOP") through
improvement in the aqueous humor outflow in the trabecular
meshwork; the potential for high CBN localization at the site of
intended treatment; the potential for CBN to contribute an
independent neuroprotective effect in addition to the standard IOP
reduction approach to treating glaucoma; the selection of a
suitable topical formulation for CBN delivery to the eye;
commencing IND-enabling toxicology studies with INM-088 in the
latter half of 2020; INM-088 reducing IOP associated with glaucoma
as well as being designed to serve as a neuroprotectant to the
retinal ganglion cells (RGC) and the optic nerve; developing a
pipeline of cannabinoid-based medications in diseases with high
unmet medical need; and delivering new therapeutic alternatives to
patients that may benefit from cannabinoid-based medicines.
With respect to the forward-looking information contained in
this news release, InMed has made numerous assumptions regarding,
among other things: the ability to recruit appropriate test
subjects; continued and timely positive preclinical and clinical
efficacy data; the speed of regulatory approvals; the effectiveness
of patent protection; 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; INM-088 may
not proceed with the anticipated benefits, timeline and structure,
or at all; InMed may not be able to advance its other product
candidates on a timely basis, or at all; 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; InMed's proprietary biosynthesis manufacturing process and
drug development programs may not deliver the expected level of
results; and InMed may not be able to provide new therapeutic
alternatives that benefit patients via cannabinoid-based medicines.
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.