Artelo Biosciences Initiates the Phase 2a Portion of its CAReS Trial EvaluatingART27.13 for the Treatment of Cancer-Related Anorexia and Weight Loss
April 25 2023 - 8:30AM
Artelo Biosciences,
Inc.
(Nasdaq: ARTL), a
clinical-stage pharmaceutical company focused on modulating
lipid-signaling pathways to develop treatments for people living
with cancer, pain, and neurological conditions, today
announced it has initiated the Phase 2a portion of its Cancer
Appetite Recovery Study (CAReS), evaluating ART27.13 for the
treatment of cancer-related anorexia and weight loss.
“To date, ART27.13 has shown favorable tolerability in patients
with anorexia and weight loss related to cancer with no significant
negative effects attributed to the experimental drug,” said Steven
D. Reich, M.D., Chief Medical Officer of Artelo. “Based on the
positive safety profile and the response pattern observed in the
Phase 1b portion of the trial, a dose of 650 micrograms will be
administered to patients in the Phase 2a.”
The Phase 2a portion of the CAReS study is a double-blind,
placebo-controlled design enrolling 40 patients randomly allocated
in a 3:1 ratio to receive ART27.12 or placebo once daily for up to
12 weeks. The study is planned to be conducted at approximately 18
clinical sites in five countries.
“We believe ART27.13 can provide a novel way to manage the
debilitating effects of anorexia and weight loss in cancer patients
who have few, if any, alternatives,” said Gregory D. Gorgas,
Artelo’s President and Chief Executive Officer. “By tripling the
number of treatment centers and broadening patient eligibility
criteria to include concurrent anti-cancer therapies, our goal is
to complete Phase 2a patient enrollment by mid-2024.”
About ART27.13ART27.13 is a highly potent,
peripherally restricted synthetic, dual G-Protein-Coupled Receptor
agonist believed to target the cannabinoid receptors CB1 and
CB2, which has the potential to increase appetite and food intake.
Originally developed by AstraZeneca plc, ART27.13 has been
evaluated in five Phase 1 clinical studies including over 200
subjects where it has 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 CAReSThe Cancer Appetite Recovery Study
(CAReS) is a Phase 1b/2a 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, 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 1b portion of the CAReS study is designed
to determine the most effective and safest dose of ART27.13 for
dosing in the Phase 2a stage. The Phase 2a portion of the CAReS
study is designed to determine estimates of activity of ART27.13 in
terms of lean body mass, weight gain, and improvement of anorexia.
(ISRCTN registry: 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 modulate 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, anxiety, pain, neuropathy, and inflammation. Led by proven
biopharmaceutical executives collaborating with highly respected
researchers and technology experts, the company 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 StatementsThis 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 the Company’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.
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relate to future events or our financial performance and involve
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Investor Relations Contact:Crescendo
Communications, LLCTel:
212-671-1020Email: ARTL@crescendo-ir.com
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