Artelo Anticipates Accelerated Clinical Development for ART27.13 Following Its Classification Change in the United Kingdom
12 January 2022 - 12:30AM
Artelo Biosciences, Inc. (Nasdaq: ARTL) announced that the United
Kingdom’s Home Office has classified the Company’s lead clinical
cannabinoid, ART27.13, as “non-controlled” and, therefore, is no
longer considered a Schedule 1 controlled substance, which would
impose limitations on its production, possession, and supply. The
Home Office is the lead government department tasked with major
economic, security and safety policies, including drug policy.
“Collaborating diligently with the Home Office, Artelo was
successful in working with governmental regulators to determine
that the chemical composition of ART27.13 should not be covered by
the Misuse of Drugs Act and, by virtue of the ongoing clinical
trials, was also exempted from the Psychoactive Substances Act in
the U.K.,” stated Andrew Yates, Ph.D., Chief Scientific Officer of
Artelo Biosciences. “As a result, Artelo will be able to treat
ART27.13 as a normal, non-scheduled Investigational Medicinal
Product, which is expected to streamline onboarding of additional
clinical sites in the U.K., accelerate enrollment of patients, and
enhance the commercial potential of ART27.13,” added Dr. Yates.
Artelo is currently enrolling patients in the U.K. in a Phase
1/2 Cancer Appetite Recovery Study (CAReS) to evaluate ART27.13 for
the treatment of anorexia in people with cancer. Cancer anorexia
affects up to 60% of patients with advanced-stage cancers and is
characterized by loss of appetite, weight loss and tissue wasting,
impoverishing quality of life, and often precedes a patient’s
death. ART27.13 was designed to be peripherally restricted,
targeting the cannabinoid receptors in the body’s periphery and not
the brain, which is a distinguishing feature of the synthetic
cannabinoid. Avoiding receptors in the central nervous system (CNS)
has the potential to deliver an effective dose for managing
anorexia while minimizing any undesired CNS effects.
About ART27.13ART27.13 is a highly potent,
peripherally restricted synthetic, dual GPCR agonist believed to
target the cannabinoid receptors CB1/CB2, which has the potential
to increase appetite and food intake. Originally developed by
AstraZeneca plc, ART27.13 has been in five Phase 1 clinical studies
including over 200 subjects where it demonstrated a statistically
significant and dose-dependent increase in body weight in healthy
subjects. Importantly, the changes in body weight were not
associated with fluid retention and the distribution of the drug
enables systemic metabolic effects while minimizing central nervous
system mediated toxicity. Artelo is advancing ART27.13 as a
supportive care therapy for cancer patients suffering from anorexia
and weight loss where the current annual global market is estimated
to be valued in excess of $2 billion.
About the CAReS StudyThe Cancer Appetite
Recovery Study (CAReS) is a Phase 1/2 randomized,
placebo-controlled trial of the Company’s lead clinical program,
ART27.13, in patients with cancer anorexia and weight loss.
Anorexia, or the lack or loss of appetite in cancer patients, may
result from the cancer and/or its treatment with radiation or
chemotherapy. It is common for patients with cancer to lose weight.
Anorexia and the resulting weight loss can affect a patient’s
health, often weakening their immune system and causing discomfort
and dehydration. A weight loss of more than 5% can predict a poor
outcome for cancer patients and a lower response to chemotherapy.
The Phase 1 portion of the CAReS study is designed to determine the
most effective and safest dose of ART27.13 that will be used in the
Phase 2 stage. The Phase 2 portion of the CAReS study is designed
to determine point estimates of activity of ART27.13 in terms of
lean body mass, weight gain, and improvement of anorexia. The study
is planned to enroll up to 24 patients in the Phase 1 and 25
participants in the Phase 2.(ISRCTN
registry: the https://www.isrctn.com/ISRCTN15607817)
About Artelo BiosciencesArtelo Biosciences,
Inc. is a clinical-stage pharmaceutical company dedicated to the
development and commercialization of proprietary therapeutics that
target lipid-signaling pathways, including the endocannabinoid
system. Artelo is advancing a portfolio of broadly applicable
product candidates designed to address significant unmet needs in
multiple diseases and conditions, including anorexia, cancer, PTSD,
pain, and inflammation. Led by proven pharmaceutical executives
collaborating with highly respected researchers and technology
experts, Artelo applies leading edge scientific, regulatory, and
commercial discipline to develop high-impact therapies. More
information is available at www.artelobio.com and
Twitter: @ArteloBio.
Forward Looking Statements
This press release contains certain
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934 and Private Securities Litigation Reform Act, as
amended, including those relating to Artelo’s product development,
clinical and regulatory timelines, market opportunity, competitive
position, possible or assumed future results of operations,
business strategies, potential growth opportunities and other
statement that are predictive in nature. These forward-looking
statements are based on current expectations, estimates, forecasts
and projections about the industry and markets in which we operate
and management’s current beliefs and assumptions. These statements
may be identified by the use of forward-looking expressions,
including, but not limited to, “expect,” “anticipate,” “intend,”
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“should,” “would” and similar expressions and the negatives of
those terms. These statements relate to future events or our
financial performance and involve known and unknown risks,
uncertainties, and other factors which may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Such factors include those set
forth in Artelo’s filings with the Securities and Exchange
Commission, including our ability to raise additional capital in
the future. Prospective investors are cautioned not to place undue
reliance on such forward-looking statements, which speak only as of
the date of this press release. Artelo undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise, except to the
extent required by applicable securities laws.
Investor Relations
Contact:Crescendo Communications, LLCTel:
212-671-1020Email: ARTL@crescendo-ir.com
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