TSX: IN
NASDAQ: INM
VANCOUVER, BC, Jan. 8, 2021 /PRNewswire/ - 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 755-102-HV Phase 1
clinical trial ("Study 102").
Results of Study 102 indicate that INM-755 cream was safe and
well-tolerated on induced open epidermal wounds, caused no systemic
or serious adverse effects, and there were no subject withdrawals
due to adverse events.
Study 102 was a randomized, double-blind, vehicle controlled,
single-center study, in 8 healthy adult volunteers to test the
tolerability of 14 days of application of the cream on epidermal
wounds under treatment procedures designed to simulate wound care
for Epidermolysis Bullosa ("EB") patients with open wounds.
Study 102 compared two strengths of INM-755 cream versus the
vehicle alone (cream base without the active drug, CBN) and versus
no treatment for a total of four treatment conditions. Each subject
had 4 small suction blisters created on Day 1. The blister roofs
were then pierced, the fluid aspirated, and the roofs were removed
to leave open wounds that were randomized (1:1:1:1) to each of the
four treatment conditions. The assigned treatment was put on a film
dressing which was then applied to the wound and surrounding area.
Each treatment was repeated daily, resulting in continuous exposure
to the cream and the dressing for 14 days. The subjects were
followed for an additional week after the 14-day treatment
period.
Local tolerability assessments were performed by a blinded
investigator daily throughout the 14-day treatment period and the
1-week follow-up. Local erythema, edema, scaling, and a
stinging/burning sensation were each assessed. Clinical wound
assessment and clinical imaging were also performed by blinded
personnel daily to characterize wound healing under the four
treatment conditions.
Of the four parameters assessed daily, erythema was the one most
frequently observed; it is expected in the setting of an open
wound. The timing and severity of erythema were similar across all
treatment groups with most occurrences being mild or moderate.
Scaling was the second most common local reaction, with no
differences in timing and severity across all treatment groups and
most of the scaling reactions were mild. Edema was not observed for
any of the treatment groups. Stinging/burning sensation was
not observed with the high concentration cream or in the untreated
wounds. The few, mild cases of stinging/burning were reported with
the vehicle and low concentration creams. Overall, no differences
were noted among the treatment groups with respect to these four
local reactions and no dose-response was observed. Despite the very
small areas treated with the investigational product, systemic
safety was evaluated by standard procedures and there were no
findings that suggested systemic adverse reactions from
treatment.
An important safety objective of this study was to assess
whether INM-755 creams interfered with normal wound healing. Study
102 was deliberately designed to provide within-subject comparisons
of the different treatment options, recognizing that inter-subject
differences in wound healing might confound assessment of treatment
effects in a small study if individual subjects were randomized to
different treatments. Using this within-subject design, 8 subjects
provided sufficient data to conclude that the active INM-755 creams
did not introduce any delay in normal wound
healing.
In summary, the safety and tolerability evaluations demonstrated
that INM-755 cream was well tolerated on open wounds and caused no
delay in wound healing. Combined with the results of InMed's prior
Phase 1 trial examining the effects of INM-755 cream on intact skin
in healthy volunteers (755-101-HV), InMed now has a strong body of
evidence demonstrating the overall safety and tolerability of
INM-755 cream. These data support moving forward into studies in
patients with EB. Regulatory applications for a Phase 2
efficacy and safety study in patients with EB are in preparation
and are planned to be filed in several countries in the first half
of 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.
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; INM-755 being safe and well-tolerated and causing no systemic
or serious adverse effects; 755-102-HV Phase 1 clinical trial
providing within-subject comparisons of the different treatment
options; the 755-101-HV and 755-102-HV Phase 1 clinical trials
demonstrating the overall safety and tolerability of INM-755 cream;
moving into clinical studies in patients with EB; filing of
regulatory applications for a Phase 2 efficacy and safety study in
patients with EB in the first half of 2021; 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; delivering
new therapeutic alternatives to patients that may benefit from
cannabinoid-based medicines; INM-755 potentially treating EB and
other dermatological diseases; 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; and the results from the 755-101-HV and
755-102-HV Phase 1 clinical trials will continue to support
continued development of INM-755 in the EB program. 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; 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 filings with the
Securities and Exchange Commission and the most recent Annual
Information Form 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.
View original
content:http://www.prnewswire.com/news-releases/inmed-announces-results-of-second-phase-1-clinical-trial-of-inm-755-cbn-cream-in-healthy-subjects-301203160.html
SOURCE InMed Pharmaceuticals Inc.