Artelo Biosciences Announces Clinical Trial Authorization to Commence Cancer Appetite Recovery Study for the Treatment of Cancer-Related Anorexia and Weight Loss

Rhea-AI Summary

Artelo Biosciences (NASDAQ: ARTL) has received Clinical Trial Authorization (CTA) in the UK for its Cancer Appetite Recovery Study (CAReS) aimed at treating cancer-related anorexia. The Phase 1/2 trial will evaluate the efficacy and safety of synthetic cannabinoid ART27.13, targeting a market of over $2 billion. With a recruitment goal of 43 patients, the company plans to initiate enrollment before year-end 2020, despite operational challenges posed by the Covid-19 pandemic. The trial addresses a significant unmet need, as cancer-related anorexia affects over 60% of advanced cancer patients.

Positive

• Received CTA in the UK for Cancer Appetite Recovery Study (CAReS).
• Targeting a market estimated over $2 billion for cancer-related anorexia.
• Plans to enroll 43 patients in the Phase 1/2 trial by year-end 2020.

Negative

• None.

First patients on track for enrollment this year

Targeting multi-billion market with no approved therapies for cancer-related anorexia

LA JOLLA, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company focused on the development of therapeutics that modulate endogenous signaling pathways, including the endocannabinoid system, today announced receipt of the Clinical Trial Authorization (CTA) in the UK for the Company’s Cancer Appetite Recovery Study (CAReS). The Medicines and Healthcare products Regulatory Agency (MHRA) authorized the initiation of the study entitled “A Phase 1/2 Trial of Synthetic Cannabinoid ART27.13 in Patients with Cancer Anorexia and Weight Loss.” Artelo expects the study to initiate enrollment before year end.

“Receiving our Clinical Trial Authorization clears the path to commence our CAReS trial and we are excited about the prospect of enrolling patients this year,” stated Andrew Yates, PhD., Program Leader for ART27.13. “We will now proceed to open up sites throughout the UK with an overall recruitment goal of 43 patients, while maintaining safe and efficient operations during the Covid-19 pandemic.”

Steven D. Reich, M.D., Artelo’s Chief Medical Officer, added, “Cancer-related anorexia is a dramatically underserved market, with no approved therapies.” Cancer-related anorexia affects greater than 60% of advanced stage cancer patients and it is characterized by loss of appetite, weight loss, poor quality of life and often precedes a patient’s death. Reich continued, “The Phase 1/2 CAReS trial is designed to determine the most effective and safest dose and to evaluate activity using criteria such as lean body mass, weight gain, and improvement of anorexia.”

About Artelo Biosciences

Artelo Biosciences, Inc. is a San Diego-based biopharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate endogenous signaling pathways, including the endocannabinoid system.  Artelo is rapidly advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, pain, inflammation, and anxiety. 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.

About ART27.13

ART27.13 is a highly potent, peripherally restricted synthetic, dual G protein-coupled receptor agonist believed to target peripheral CB₁/CB₂ receptors, 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 plans to advance 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.

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 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. 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,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “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 the Company’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. The Company 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, LLC
Tel: 212-671-1020
Email: ARTL@crescendo-ir.com

FAQ

What is Artelo Biosciences' recent clinical trial authorization for?

Artelo Biosciences received Clinical Trial Authorization for its Cancer Appetite Recovery Study (CAReS) to evaluate ART27.13 in cancer-related anorexia patients.

What will the Phase 1/2 trial of ART27.13 investigate?

The trial will investigate the efficacy and safety of ART27.13 and its potential to increase appetite and improve weight gain in cancer patients.

When is Artelo planning to start patient enrollment for the CAReS trial?

Artelo plans to initiate patient enrollment for the CAReS trial before the end of 2020.

What is the significance of cancer-related anorexia in cancer patients?

Cancer-related anorexia affects more than 60% of advanced cancer patients, leading to weight loss and poor quality of life, highlighting the need for effective treatments.