Artelo Biosciences Files Patent Application for New Formulation of ART27.13

Rhea-AI Summary

Artelo Biosciences (NASDAQ: ARTL) has filed a composition of matter patent application with the UK Patent Office for a new solid dosage formulation related to its lead clinical program, ART27.13. This formulation aims to treat cancer patients suffering from anorexia. The company has received Clinical Trial Authorization for its Cancer Appetite Recovery Study (CAReS) and plans to begin enrollment by year-end 2020. If allowed, the patent application is expected to secure exclusivity for ART27.13 through 2041.

Positive

• Filing of a new patent application to protect ART27.13, enhancing its market position.
• Receipt of Clinical Trial Authorization for the CAReS study, moving forward with ART27.13's development.
• ART27.13 has shown potential in previous studies, indicating a statistically significant increase in body weight.

Negative

• None.

Expanding the patent estate for the lead clinical program to treat cancer anorexia

LA JOLLA, Calif., Dec. 09, 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 that it has filed a composition of matter patent application directed to a new solid dosage formulation, including its method of use, with the UK Patent Office. This formulation is related to the Company’s lead clinical program, ART27.13. Artelo’s ART27.13 is a G-Protein Coupled Receptor (GPCR) agonist and is being developed as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Recently, the Company received Clinical Trial Authorization in the UK to initiate its Cancer Appetite Recovery Study (CAReS) of ART27.13 in cancer patients with anorexia and weight loss. Artelo remains on track to initiate enrollment in its CAReS study before the end of the year.

“The filing of this new patent underpins our commitment to the development of ART27.13 as a product candidate with a profile that holds significant promise for the treatment of cancer-related anorexia,” stated Gregory D. Gorgas, Artelo’s President and Chief Executive Officer. “We understand cancer-related anorexia to be a significant unmet need, with no regulatory approved therapies or standard of care worldwide, and believe that ART27.13 has been further optimized for use in cancer patients with our new dosage form. We are looking forward to begin opening clinical sites and starting enrollment in our CAReS study of ART27.13 within the coming weeks.”

The filing of this new patent application is expected to support a strong patent exclusivity position for ART27.13 through 2041, if allowed.

About ART27.13
ART27.13 is a highly potent, peripherally restricted synthetic, dual GPCR 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.

About Artelo Biosciences
Artelo Biosciences, Inc. is a San Diego-based biopharmaceutical company dedicated to the development and commercialization of proprietary therapeutics targeting 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, PTSD, pain, 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 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 the significance of the patent filed by Artelo Biosciences for ART27.13?

The patent filing is crucial as it aims to secure a strong exclusivity position for ART27.13, potentially protecting the product until 2041.

When does Artelo Biosciences plan to start enrollment for the CAReS study?

Artelo plans to initiate enrollment for the Cancer Appetite Recovery Study (CAReS) before the end of 2020.

What is ART27.13 and its intended use?

ART27.13 is a dual GPCR agonist being developed as a supportive care therapy for cancer patients suffering from anorexia and weight loss.

What market potential does ART27.13 have?

The global market for therapies addressing cancer-related anorexia is estimated to exceed $2 billion annually.