Artelo Biosciences Announces New Data on ART12.11 Tablets Showing Improved Pharmacokinetics to Epidiolex

Artelo Biosciences, Inc. recently announced nonclinical results on ART12.11, its proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). The findings were presented by Professor Saoirse O’Sullivan, Vice President of Translational Science at Artelo Biosciences, at the International Medical Cannabis Conference (IMCCB-25), held February 13-14, 2025, at the University of Bern, Switzerland.

Professor O’Sullivan’s presentation, “A Cannabidiol Cocrystal (ART12.11) Tablet Has Comparable Pharmacokinetics to Epidiolex,” highlighted results from canine studies evaluating Artelo’s oral solid formulations of ART12.11 against the liquid formulation of Epidiolex, the only FDA-approved CBD therapy. The studies showed that two different tablet formulations of ART12.11 achieved CBD and metabolite exposure levels similar or greater to the equivalent dose of Epidiolex, supporting the potential of ART12.11 as an alternative formulation of CBD.

Solid-dose formulations, such as tablets, may have certain advantages including improved stability, ease of dosing, lower cost-of-goods or enhanced patient adherence. Cocrystallization, a pharmaceutical approach to improving drug solubility and bioavailability, plays a key role in ART12.11’s formulation, addressing challenges associated with CBD’s physical properties, enabling the manufacture of a simple compression tablet with high drug loading. Artelo is evaluating multiple tablet prototypes of ART12.11, each containing 100mg of CBD with the potential to increase the drug loading further.

“We are highly encouraged by these results, which reinforce our belief in ART12.11’s potential as a commercially attractive advancement compared to existing CBD formulations or those in development,” said Andrew Yates, Senior Vice President and Chief Scientific Officer at Artelo. “As a proprietary cocrystal of CBD and TMP, ART12.11 has demonstrated improved pharmacokinetics, enhanced efficacy, and significant pharmaceutical advantages in nonclinical studies. Tableted ART12.11 offers a patent-protected, scalable, and low-cost approach for developing CBD as a tablet in conditions previously seen as out-of-scope with CBD’s current pharmaceutical limitations. We look forward to exploring ART12.11’s advantages further as we progress into human studies.”

ART12.11 is Artelo’s wholly owned, proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). Isolated as a single crystalline form, ART12.11 has exhibited better pharmacokinetics and improved efficacy compared to other forms of CBD in nonclinical studies. Significantly enhanced pharmaceutical properties, including physicochemical, pharmacokinetic, and pharmacodynamic advantages have been observed with ART12.11. Artelo believes a more consistent and improved bioavailability profile in a solid dosage form may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The U.S. issued composition of matter patent for ART12.11 is enforceable until December 10, 2038.

Artelo Biosciences, Inc. is a clinical-stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways. 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, dermatologic conditions, 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.

The IMCCB-25 seeks to inform participants about the latest evidence and concepts regarding cannabis- and cannabinoid-based therapies. It aims to assist prescribers in practically implementing best practices based on current research, expert opinions and therapy guidelines. The IMCCB-25 conference covers a broad spectrum of topics, including basic and clinical methodologies, safety, analytics, pharmaceutics, regulatory and legal considerations, pharmacological insights, and technological advancements. The emphasis is on practical implications for patients, researchers, medical persons, and industry leaders alike. Additional topics include palliative care, women medicine, psychiatry and geriatric diseases, niche indications as well as non-medical cannabis use disorders. More information about IMCCB-25 can be found at https://www.imccb.org