Artelo Biosciences Announces New Data on ART12.11 Tablets Showing Improved Pharmacokinetics to Epidiolex®
Artelo Biosciences (NASDAQ: ARTL) has announced new nonclinical results for ART12.11, its proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). The findings, presented at the International Medical Cannabis Conference in Switzerland, demonstrated that ART12.11 tablets achieved CBD and metabolite exposure levels similar or greater to equivalent doses of Epidiolex®, the only FDA-approved CBD therapy.
The company's tablet formulations, containing 100mg of CBD, show potential advantages including improved stability, easier dosing, lower cost-of-goods, and enhanced patient adherence. The cocrystallization approach addresses CBD's physical property challenges, enabling the manufacture of simple compression tablets with high drug loading. These results support ART12.11's potential as an alternative CBD formulation with improved pharmacokinetics and enhanced efficacy in nonclinical studies.
Artelo Biosciences (NASDAQ: ARTL) ha annunciato nuovi risultati non clinici per ART12.11, la sua composizione proprietaria di cocrystal di cannabidiolo (CBD) e tetrametilpirazina (TMP). I risultati, presentati alla Conferenza Internazionale sulla Cannabis Medica in Svizzera, hanno dimostrato che le compresse ART12.11 hanno raggiunto livelli di esposizione al CBD e ai suoi metaboliti simili o superiori a dosi equivalenti di Epidiolex®, l'unica terapia a base di CBD approvata dalla FDA.
Le formulazioni in compresse dell'azienda, contenenti 100 mg di CBD, mostrano potenziali vantaggi tra cui stabilità migliorata, dosaggio più semplice, costi di produzione inferiori e maggiore aderenza da parte dei pazienti. L'approccio alla cocrystallizzazione affronta le sfide legate alle proprietà fisiche del CBD, consentendo la produzione di compresse semplici con un elevato caricamento del farmaco. Questi risultati supportano il potenziale di ART12.11 come formulazione alternativa di CBD con farmacocinetica migliorata e maggiore efficacia negli studi non clinici.
Artelo Biosciences (NASDAQ: ARTL) ha anunciado nuevos resultados no clínicos para ART12.11, su composición de cocrystal patentada de cannabidiol (CBD) y tetrametilpirazina (TMP). Los hallazgos, presentados en la Conferencia Internacional de Cannabis Medicinal en Suiza, demostraron que las tabletas ART12.11 lograron niveles de exposición al CBD y a sus metabolitos similares o superiores a dosis equivalentes de Epidiolex®, la única terapia de CBD aprobada por la FDA.
Las formulaciones en tabletas de la compañía, que contienen 100 mg de CBD, muestran ventajas potenciales que incluyen estabilidad mejorada, dosificación más fácil, menor costo de producción y mayor adherencia del paciente. El enfoque de cocrystallización aborda los desafíos de las propiedades físicas del CBD, lo que permite la fabricación de tabletas de compresión simples con una alta carga de fármaco. Estos resultados apoyan el potencial de ART12.11 como una formulación alternativa de CBD con farmacocinética mejorada y mayor eficacia en estudios no clínicos.
아르텔로 바이오사이언스(나스닥: ARTL)는 칸나비디올(CBD)과 테트라메틸피라진(TMP)의 독자적인 코크리스탈 조성물인 ART12.11에 대한 새로운 비임상 결과를 발표했습니다. 스위스에서 열린 국제 의료 대마초 컨퍼런스에서 발표된 이 발견은 ART12.11 정제가 에피디오렉스(Epidiolex®)와 동일하거나 더 높은 수준의 CBD 및 대사물 노출을 달성했다는 것을 보여주었습니다. 에피디오렉스는 FDA에 의해 승인된 유일한 CBD 치료제입니다.
회사의 100mg CBD가 포함된 정제 제형은 개선된 안정성, 더 쉬운 복용, 낮은 생산 비용 및 환자 순응도 향상과 같은 잠재적 이점을 보여줍니다. 코크리스탈화 접근 방식은 CBD의 물리적 속성 문제를 해결하여 높은 약물 함량의 간단한 압축 정제를 제조할 수 있게 합니다. 이러한 결과는 ART12.11이 개선된 약리학적 작용과 비임상 연구에서의 효능 향상이 있는 대체 CBD 제형으로서의 잠재력을 뒷받침합니다.
Artelo Biosciences (NASDAQ: ARTL) a annoncé de nouveaux résultats non cliniques pour ART12.11, sa composition de cocrystal brevetée de cannabidiol (CBD) et de tétraméthylpyrazine (TMP). Les résultats, présentés lors de la Conférence internationale sur le cannabis médical en Suisse, ont démontré que les comprimés ART12.11 ont atteint des niveaux d'exposition au CBD et à ses métabolites similaires ou supérieurs à ceux des doses équivalentes d'Epidiolex®, le seul traitement à base de CBD approuvé par la FDA.
Les formulations de comprimés de l'entreprise, contenant 100 mg de CBD, montrent des avantages potentiels tels qu'une stabilité améliorée, un dosage plus facile, des coûts de production réduits et une meilleure adhésion des patients. L'approche de cocrystallisation répond aux défis liés aux propriétés physiques du CBD, permettant la fabrication de comprimés de compression simples avec une forte charge médicamenteuse. Ces résultats soutiennent le potentiel d'ART12.11 en tant que formulation alternative de CBD avec une pharmacocinétique améliorée et une efficacité accrue dans les études non cliniques.
Artelo Biosciences (NASDAQ: ARTL) hat neue nichtklinische Ergebnisse für ART12.11, seine proprietäre Cocrystal-Zusammensetzung aus Cannabidiol (CBD) und Tetramethylpyrazin (TMP), bekannt gegeben. Die Ergebnisse, die auf der International Medical Cannabis Conference in der Schweiz präsentiert wurden, zeigten, dass ART12.11-Tabletten ähnliche oder höhere CBD- und Metabolitspiegel erreichten als äquivalente Dosen von Epidiolex®, der einzigen von der FDA zugelassenen CBD-Therapie.
Die Tablettenformulierungen des Unternehmens, die 100 mg CBD enthalten, zeigen potenzielle Vorteile wie verbesserte Stabilität, einfachere Dosierung, niedrigere Produktionskosten und eine höhere Patientenadhärenz. Der Ansatz der Cocrystallisation geht die Herausforderungen der physikalischen Eigenschaften von CBD an und ermöglicht die Herstellung einfacher Kompressionstabletten mit hoher Wirkstoffbeladung. Diese Ergebnisse unterstützen das Potenzial von ART12.11 als alternative CBD-Formulierung mit verbesserter Pharmakokinetik und erhöhter Wirksamkeit in nichtklinischen Studien.
- ART12.11 tablets showed comparable or better CBD exposure levels than Epidiolex
- Potential for lower production costs through tablet formulation
- Patent-protected technology with scalable manufacturing process
- Improved drug stability and patient adherence potential
- Results are from canine studies only, human trials yet to be conducted
- Product still in early development phase
Insights
The latest preclinical data for Artelo's ART12.11 represents a potentially significant advancement in pharmaceutical CBD delivery, with several key commercial implications:
The demonstrated bioequivalence to Epidiolex (which generated
- Manufacturing efficiency: The cocrystallization process enables simple compression tablet manufacturing with high drug loading (100mg CBD per tablet), potentially reducing production costs significantly compared to liquid formulations
- Stability improvements: Solid dosage forms typically offer superior shelf-life and reduced storage/transportation requirements compared to liquids
- Patient compliance: Tablet formulation enables precise dosing and easier administration, particularly important for pediatric epilepsy patients - Epidiolex's primary market
The proprietary cocrystal technology provides strong patent protection through 2041, creating a substantial barrier to entry. This is particularly valuable given that Epidiolex's composition of matter patent expires in 2035, potentially opening the market to generic competition.
The successful demonstration of comparable or superior pharmacokinetics in canine studies significantly de-risks the development program. If these results translate to humans, ART12.11 could offer a more cost-effective and patient-friendly alternative to Epidiolex, while maintaining therapeutic equivalence.
The scalable, low-cost manufacturing approach could enable competitive pricing while maintaining healthy margins - a important advantage in markets where cost containment is increasingly important. The potential to increase drug loading beyond 100mg per tablet could further enhance manufacturing efficiency and reduce costs.
SOLANA BEACH, Calif., Feb. 14, 2025 (GLOBE NEWSWIRE) -- 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, dermatological or neurological conditions, today 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.”
About ART12.11
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.
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. 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 and X: @ArteloBio.
About IMCCB-25
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
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:
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Tel: 212-671-1020
Email: ARTL@crescendo-ir.com
FAQ
What are the key advantages of ARTL's ART12.11 tablets compared to Epidiolex?
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How does ARTL's cocrystallization technology improve CBD delivery?
What stage of development is ARTL's ART12.11 currently in?
