InMed Pharmaceuticals Announces Commencement of Phase 2 Clinical Trial Investigating Cannabinol (CBN), a Rare Cannabinoid, in the Treatment of Epidermolysis Bullosa
September 30 2021 - 6:30AM
InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq:
INM), a leader in the manufacturing and clinical development of
rare cannabinoids, today announced that it has commenced its Phase
2 clinical trial of INM-755 (cannabinol) cream in the treatment of
Epidermolysis Bullosa (“EB”). This marks the first time cannabinol
has advanced to a Phase 2 Clinical trial to be studied as a
therapeutic option to treat a disease.
This study will be taking place at eleven sites
across seven countries including Austria, Germany, Greece, France,
Italy, Israel and Serbia. Clinical Trial Applications (“CTAs”) have
been filed in all participating countries with regulatory authority
and ethics committee approvals currently in place in four countries
(Austria, France, Greece, Israel). The first site initiation visit
was completed at a clinical site in Austria, where screening for
eligible patients will begin shortly.
“The start of this Phase 2 clinical trial
represents a very important step forward to test the efficacy of
INM-755 (cannabinol) cream in treating epidermolysis bullosa, a
disease that has very few treatment options,” stated Alexandra
Mancini, Senior Vice President of Clinical and Regulatory Affairs
at InMed. “Based on our earlier studies, we are hopeful that our
cannabinol cream will prove to be a safe and effective treatment
for people living with this severe genetic skin disease.”
“The achievement of this important milestone
along the continuum of pharmaceutical drug development in EB
supports our belief that this class of compounds hold broad
therapeutic potential,” said Eric A. Adams, President and CEO of
InMed. “This study further demonstrates InMed’s leadership in the
development of rare cannabinoids as therapeutic products. In
addition, we look forward to achieving key milestones of our second
CBN drug candidate for the treatment of glaucoma in the year
ahead.”
INM-755 is a cannabinol (CBN) cream intended as
a topical therapy to treat EB and potentially other dermatological
diseases. Preclinical data demonstrate that INM-755 (cannabinol)
cream 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. Phase 1 data in healthy volunteers
demonstrated INM-755 (cannabinol) cream to be well-tolerated on
both normal, intact skin as well as on open wounds and caused no
delay in wound healing.
The 755-201-EB study is designed to enroll up to
20 patients, conservatively within 12 months. All four subtypes of
inherited EB, being EB Simplex, Dystrophic EB, Junctional EB, and
Kindler Syndrome, are eligible for this study in which InMed will
evaluate the safety of INM-755 (cannabinol) cream and its
preliminary efficacy in treating symptoms and healing wounds over a
28-day period. The study will use a within-patient, double-blind
design whereby matched index areas will be randomized to INM-755
(cannabinol) cream or vehicle cream as a control.
About InMed: InMed
Pharmaceuticals is a clinical-stage company developing a pipeline
of cannabinoid-based pharmaceutical drug candidates, initially
focused on the therapeutic benefits of cannabinol (“CBN”), and is
developing IntegraSyn™ to produce pharmaceutical-grade
cannabinoids. The Company is dedicated to delivering new
therapeutic alternatives to patients that may benefit from
cannabinoid-based pharmaceutical drugs. For more information,
visit www.inmedpharma.com.
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: Colin ClancySenior Director,
Investor RelationsT: +1 604 416 0999E: cclancy@inmedpharma.com
Edison Group:Joe Green/Laine
YonkerT: +1.646.653.7030/+1.646.653.7035E:
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 statements are frequently, but not
always, identified by words such as “expects”, “anticipates”,
“believes”, “intends”, “potential”, “possible”, “would” and similar
expressions. Such statements, based as they are on current
expectations of management, inherently involve numerous risks,
uncertainties and assumptions, known and unknown, many of which are
beyond our control. 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: being a leader in the manufacturing and
clinical development of rare cannabinoids; the Phase 2 Clinical
trial taking place at eleven sites across seven countries with
screening for eligible patients beginning shortly and enrolling up
to 20 patients within 12 months; being able to demonstrate that
cannabinol cream is a safe and effective treatment for
epidermolysis bullosa; the cannabinoid class of compounds
potentially holding broad therapeutic potential; achieving key
milestones for the glaucoma program in the year ahead; cannabinol
(CBN) cream potentially treating epidermolysis bullosa (EB) and
potentially other dermatological diseases; and developing a
pipeline of cannabinoid-based pharmaceutical drug candidates and
IntegraSyn™ to produce pharmaceutical-grade cannabinoids.
With respect to the forward-looking information
contained in this news release, InMed has made numerous assumptions
regarding, among other things: 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: regulatory filings may not be filed or
approved on a timely basis, or at all; 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’s
stand-alone business is disclosed in InMed’s 10-K filed with the
Security and Exchange Commission.
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.
InMed Pharmaceuticals (NASDAQ:INM)
Historical Stock Chart
From Apr 2024 to May 2024
InMed Pharmaceuticals (NASDAQ:INM)
Historical Stock Chart
From May 2023 to May 2024