VANCOUVER, BC, Nov. 25, 2020 /CNW/ - InMed
Pharmaceuticals Inc. ("InMed" or the "Company") (NASDAQ: INM)
(TSX: IN), 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 top-line results from its 755-101-HV Phase 1
clinical trial ("Study 101").
Results of Study 101 indicate that INM-755 was safe and
well-tolerated on intact skin, caused no systemic or serious
adverse effects, and there were no subject withdrawals due to
adverse events. Drug concentrations in the blood were very low, as
expected.
Study 101 was a randomized, vehicle-controlled, double-blind,
Phase 1 trial, that examined the safety and tolerability of two
strengths of INM-755 cream on intact skin in 22 healthy adult
volunteers over a 14-day treatment period.
Study 101 compared two strengths of INM-755 cream with a vehicle
(cream base without CBN) under treatment procedures designed to
create intense conditions for assessing skin irritation potential.
The entire upper back of each subject, representing 5% body surface
area ("BSA"), had cream applied and was then covered with a film
dressing (bandage). This application was repeated daily, resulting
in continuous exposure to the cream and the dressing for 14 days.
These treatment conditions simulate what occurs for some EB
patients who have large areas of skin covered with such a dressing
daily.
Local tolerability was assessed daily in a standardized way for
erythema (redness), edema (fluid accumulation/swelling), scaling
(flaking skin), and stinging/burning. These assessments were made
by trained clinic personnel who were blinded as to which treatment
the patient was assigned (active versus vehicle only).
Comparison of the active and vehicle treatment groups
demonstrated a slightly higher incidence and intensity of erythema
and scaling in the INM-755 groups. These effects were not
dose-dependent, with both the high and low-concentration INM-755
groups showing similar results.
The majority of subjects in all groups had no events for the
four monitored local tolerability parameters on most days over the
treatment period. Local reactions that did occur were mostly mild
or moderate and resolved without intervention. The occurrence of
mild erythema and stinging/burning in some subjects from the
vehicle group suggests that the administered vehicle and/or the
film dressing may have contributed to observed local reactions
across all study groups. Contact dermatitis is commonly seen with
film dressings like those used in this study and by EB
patients.
A very low amount of drug was measured in the blood of subjects
who received the high-concentration INM-755 cream. CBN levels were
too low to be measured in most subjects in the low-concentration
INM-755 group. No systemic adverse effects were caused by INM-755
exposure in this study. Systemic safety was evaluated by standard
procedures that included reporting adverse events, use of
concomitant medications, findings from physical examinations,
electrocardiograms, measurements of vital signs, and the full set
of hematology, chemistry, and urinalysis laboratory parameters.
Additionally, Study 101 assessed subject-reported outcomes for
alertness, calmness, and mood using the Bond-Lader Visual Analogue
Scale, and internal perception, external perception, and "feeling
high" using the Bowdle Visual Analogue Scale. Treatment of 5% BSA
daily for 14 days with INM-755 cream did not cause any effects on
these subject-reported feelings.
In summary, these results demonstrate an acceptable local safety
profile of treating intact skin in healthy volunteers and indicate
only low-level systemic exposure from topical administration which
did not lead to any systemic adverse effects. Study 101 is the
first of two Phase 1 clinical trials conducted in healthy
volunteers. The second, 755-102-HV Phase 1 trial ("Study 102"),
which recently completed subject treatment, is investigating the
effect of INM-755 cream on small epidermal wounds. The Company
anticipates reporting the results from Study 102 in early first
quarter of calendar 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.
Investor Contact:
InMed Pharmaceuticals
Inc.
Brendan Payne, Director – Investor
Relations
T:
+1.604.669.7207
E:
info@inmedpharma.com
Edison Advisors for InMed Pharmaceuticals
Joe Green/Laine Yonker
T:
+1.646.653.7030/+1.646.760.0321
E:
jgreen@edisongroup.com / lyonker@edisongroup.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: leading the way in the clinical development of
CBN; the indications of the results from the 755-101-HV Phase 1
clinical trial and its support for continued development of INM-755
in the EB program; the purpose for which INM-755 is being developed
and its potential to treat certain diseases; the anticipation of
the results of the 755-102-HV trial in early first quarter of
calendar 2021; that a second phase clinical trial will be completed
before advancing into therapeutic trials with EB subjects; that
INM-755 may help to relieve EB symptoms, such as inflammation and
pain, as well potentially restore the integrity of the skin in a
subset of EB Simplex patients; developing a pipeline of
cannabinoid-based medications in diseases with high unmet medical
need; the potential therapeutic and safety characteristics of CBN;
and the potential treatments of INM-755.
With respect to the forward-looking information contained in
this news release, InMed has made numerous assumptions regarding,
among other things: that InMed will lead the way in the clinical
development of CBN; the results from the 755-101-HV Phase 1
clinical trial will continue to support continued development of
INM-755 in the EB program; the results of the 755-102-HV trial will
be available in early first quarter of calendar 2021. 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; further
results may not support continued development of INM-755 in the EB
program; results of the 755-102-HV trial may not be favorable or
may be delayed; demand or interest for InMed's products may
decrease or cease; and economic and market conditions may become
unstable or unfavorable. 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.