InMed Pharmaceuticals Submits Clinical Trial Applications to Evaluate INM-755 (Cannabinol) Cream in a Phase 2 Trial for Epide...
April 28 2021 - 7:30AM
InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM;
TSX:IN), a world leader in the clinical development of cannabinol
(“CBN”), today announced that it has filed Clinical Trial
Applications (“CTAs”) in Austria, Israel and Serbia as part of a
Phase 2 clinical trial of INM-755 (cannabinol) cream in
Epidermolysis Bullosa (“EB”). Additional CTAs for 755-201-EB (the
‘201 study) will be submitted to National Competent Authorities
(“NCAs”) and Ethics Committees (“ECs”) in France, Germany, Greece,
and Italy in the coming weeks.
Responses from the NCAs and ECs are expected throughout July and
August 2021; timing will vary slightly by country due to
differences in local procedures.
“It is very exciting to be taking this important next step to
test the efficacy of our cannabinol cream in EB patients. We are
optimistic, based on our preclinical studies, that INM-755 cream
may provide some much-needed help for these patients,” stated
Alexandra Mancini, Senior Vice President of Clinical and Regulatory
Affairs at InMed. “Once we receive the necessary approvals, patient
enrollment will begin as soon as possible, with results expected in
the second half of 2022.”
The ‘201 study is designed to enroll up to 20 patients,
conservatively within 10-12 months, and will take place at 10
pre-qualified clinical sites in the above-mentioned countries. 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.
Filing CTAs in these countries to the NCAs serve the same
purpose as filing Investigational New Drug (“IND”) Applications to
the U.S. Food and Drug Administration (“FDA”). The NCAs review the
dossier that summarizes all nonclinical and clinical studies
conducted to date and quality data regarding the manufacturing of
sterile INM-755 (cannabinol) cream in the context of the proposed
clinical study. The ECs fulfill the same role as Institutional
Review Boards (“IRBs”) in the U.S., focusing their reviews
primarily on the protocol, investigator’s brochure, and informed
consent documents to assess the ethical and safety aspects of the
proposed study.
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”), in diseases with high
unmet medical need. 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 INM-755: INM-755 is a cannabinol
(CBN) cream intended as a topical therapy to treat epidermolysis
bullosa (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.
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:Edison GroupJoe Green/Laine
YonkerT: +1.646.653.7030/+1.646.653.7035E:
jgreen@edisongroup.com lyonker@edisongroup.com
Cautionary Note Regarding Forward-Looking
Information:
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 potential for
INM-755 cream to provide help for EB patients; the submission of
additional clinical trial applications in Italy, France, Germany
and Greece and the timing thereof, and the expected timing of
responses; patient enrollment and the timing thereof; anticipated
enrollment and locations of clinical sites; anticipated evaluations
and timing for treating symptoms and healing wounds; timing of
expected results and any future updates; and anticipated responses
from regulatory authorities and ethics committees. 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 locations and timing of trials and additional submissions will
occur as anticipated; patients will be available and willing to
enroll and the intended evaluations for each study will be made.
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; trials and additional submissions may not happen as planned
or at all; 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.
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