Artelo Biosciences Completes Enrollment of the First Three Cohorts in its CAReS Study Evaluating ART27.13 for the Treatment of Cancer-Related Anorexia and Weight Loss
July 19 2022 - 9:07AM
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 the
completion of enrollment of the first three cohorts in the Cancer
Appetite Recovery Study (CAReS) and the initiation of a fourth
cohort expected to complete the first stage of the Phase 1b
clinical trial of ART27.13.
“The CAReS safety review committee has reviewed the data thus
far and has concluded that ART27.13 has been well-tolerated with no
serious adverse events attributable to the investigational drug in
patients suffering from anorexia associated with cancer,” said
Steven D. Reich, M.D., Chief Medical Officer of Artelo.
“Remarkably, the safety profile of ART27.13 appears more benign
among cancer patients participating in CAReS than observed in
healthy volunteers in prior Phase 1 studies. Furthermore, we have
seen pharmacokinetics consistent with the AstraZeneca experience
and an improvement in anorexia from each dose escalation.”
The CAReS Phase 1b stage focuses on the safety of ascending
doses with the objective of identifying the optimal dose for the
randomized Phase 2a portion of the study, in which additional
safety and activity will be evaluated. The mild to moderate adverse
events observed in CAReS that have been attributed to ART27.13
required no dose reductions or terminations and many of the adverse
events required no medical intervention at all. Given the
encouraging safety profile and dose-response trend to date, with
the goal of maximizing potential utility of ART27.13, Artelo has
elected to open enrollment for six patients at a 650 microgram dose
per the option in the approved study protocol.
“We remain highly encouraged by the clinical observations among
the patients successfully enrolled in CAReS,” added Gregory D.
Gorgas, President and Chief Executive Officer of Artelo. “With six
participating sites in three countries, we expect to efficiently
complete the Phase 1b stage of CAReS during the third quarter and
initiate the randomized Phase 2a in the fourth quarter of this
year, which is planned to include additional sites in Europe and
the United Kingdom.”
About ART27.13ART27.13 is a highly potent,
peripherally restricted synthetic, dual G-Protein Couple 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 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 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 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 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 Biosciences Artelo 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
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Securities Exchange Act of 1934 and Private Securities Litigation
Reform Act, as amended, including those relating to the Company’s
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Investor Relations Contact:Crescendo
Communications, LLCTel:
212-671-1020Email: ARTL@crescendo-ir.com
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