InMed Announces Update on Phase 2 Clinical Trial Investigating INM-755 Cannabinol Cream for Epidermolysis Bullosa
July 25 2022 - 7:30AM
InMed Pharmaceuticals Inc. (“InMed” or the
“Company”) (Nasdaq: INM), a leader in the research, development,
manufacturing and commercialization of rare cannabinoids, today
provided an update on its Phase 2 clinical trial using
investigational drug INM-755 cannabinol (“CBN”) cream for the
treatment of patients with epidermolysis bullosa (“EB”).
Adolescent patients now eligible to
participate in clinical trial
Based on the safety data of the first five adult
patients who completed the Phase 2 study, an independent Data
Monitoring Committee (“DMC”) agreed it is safe to allow the
enrollment of adolescent patients with EB, defined as persons aged
twelve to seventeen, into InMed’s Phase 2 clinical trial evaluating
INM-755 CBN cream for the treatment of EB. The first adult patient
was enrolled in December 2021 and, to date, nine patients have been
enrolled in the study. The inclusion of adolescents will have a
positive impact in the enrollment rate for the remainder of the
clinical trial.
First adolescent patient enrolled into
clinical trial
With the DMC approval to enroll adolescent
patients into InMed’s INM-755 Phase 2 clinical trial, the first
adolescent patient with EB has been enrolled into the clinical
trial and has completed treatment at the clinical site in
Greece.
Patent granted in Japan
InMed has recently been granted a patent for the
use of CBN in the treatment of EB in Japan. This patent allows for
the use of topically administered CBN in patients with
epidermolysis bullosa simplex (EBS). The Company’s overall patent
strategy is to continue to prosecute patent applications in other
jurisdictions including Europe and the United States.
Eight clinical trial sites fully
activated
InMed’s Phase 2 clinical trial now has eight
clinical trial sites fully activated to screen and enroll patients.
Two more sites are expected to be fully activated soon. The
clinical trial is taking place in seven countries including
Austria, Germany, Greece, France, Italy, Israel and Spain. The
planned clinical site in Serbia will not be participating in the
study due to staffing capacity issues related to the ongoing impact
of the COVID-19 virus.
“We are pleased that the initial safety data
from InMed’s Phase 2 EB clinical trial has allowed the inclusion of
adolescent patients,” stated Alexandra Mancini, Senior Vice
President of Clinical and Regulatory Affairs at InMed. “With the
inclusion of adolescents and increased number of patients available
for screening, the target remains to complete enrollment of 20
patients in 2022.”
The Phase 2 study, 755-201-EB, is designed to
enroll up to 20 patients. All four subtypes of inherited EB, being
EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome, are
eligible for this study. 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 uses a
within-patient, double-blind design whereby matched index areas
will be randomized to INM-755 (cannabinol) cream or vehicle cream
as a control. To learn more about this EB study, view
the detailed study description on the National Institutes
of Health (NIH) clinicaltrials.gov website.
Learn more about InMed’s INM-755 EB study:
https://www.inmedpharma.com/pharmaceutical/inm-755-for-epidermolysis-bullosa/
What is epidermolysis
bullosa?Epidermolysis bullosa, or EB, is a group of rare
genetic skin diseases characterized by fragile skin that can lead
to extensive blistering and wounding. It affects skin and mucous
membranes, particularly of the gastrointestinal tract,
genitourinary and respiratory systems. It is a debilitating disease
affecting a small number of people, thus earning it an
orphan-disease status. The disease has no definitive cure and all
currently approved treatments are directed towards symptom relief.
Learn more:
https://www.inmedpharma.com/learn/what-is-epidermolysis-bullosa/.
About InMed: InMed
Pharmaceuticals is a global leader in the research, development,
manufacturing and commercialization of rare cannabinoids. Together
with its subsidiary BayMedica LLC, the Company has unparalleled
cannabinoid manufacturing capabilities to serve a spectrum of
consumer markets, including pharmaceutical and health and wellness.
InMed is also a clinical-stage company developing a pipeline of
rare cannabinoid therapeutics and dedicated to delivering new
treatment alternatives to patients that may benefit from
cannabinoid-based pharmaceutical drugs. For more information,
visit www.inmedpharma.com and www.baymedica.com.
Investor Contact: Colin ClancyVice President,
Investor Relations & Corporate CommunicationsT:
+1.604.416.0999E: cclancy@inmedpharma.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: an update on Phase 2 clinical trial
investigating INM-755 cannabinol cream for EB; the Phase 2 clinical
trial recently being expanded to include adolescents following
independent review of early safety data; the inclusion of
adolescents having a positive impact in the enrollment rate for the
remainder of the clinical trial and the target remains to complete
enrollment of 20 patients in 2022; being granted a patent for the
use of CBN in the treatment of EB in Japan; continuing to prosecute
patents in other jurisdictions; having eight clinical trial sites
fully activated to screen and enroll patients with two more sites
expected to be fully activated soon; being able to demonstrate that
cannabinol cream is a safe and effective treatment for
epidermolysis bullosa; continuing to prosecute patents in other
jurisdictions, including being a global leader in the research,
development, manufacturing and commercialization of rare
cannabinoids; and delivering new treatment alternatives to patients
that may benefit from cannabinoid-based pharmaceutical drugs.
With respect to the forward-looking information
contained in this news release, InMed has made numerous assumptions
regarding, among other things: the ability to obtain all necessary
regulatory approvals on a timely basis, or at all; 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. A
complete discussion of the risks and uncertainties facing InMed’s
stand-alone business is disclosed in InMed’s Annual Report on Form
10-K and other filings with the Security and Exchange Commission on
www.sec.gov.
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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