Artelo Biosciences Presents Highly Encouraging Data Towards Developing a Solid Dosage Form of ART12.11 at CT-CANN24
Artelo Biosciences (Nasdaq: ARTL) presented new pre-clinical data on ART12.11 at the CT-CANN24 conference, demonstrating that ART12.11, a patented cocrystal of CBD and TMP, has comparable pharmacokinetics to Epidiolex in rats. Epidiolex, an FDA-approved oral CBD solution, saw over $845 million in net sales in 2023. ART12.11, in an unoptimized formulation, showed similar CBD levels in plasma to Epidiolex, suggesting potential for a solid dosage form that is preferred for adolescents and adults due to better dosing precision, storage, and transport. Previous animal studies indicated ART12.11 outperformed CBD in stress-induced anxiety and depression with a lower CBD amount. Artelo is developing an optimized tablet form of ART12.11 for clinical studies, aiming to broaden CBD research in larger populations.
- ART12.11 demonstrated comparable pharmacokinetics to Epidiolex, an FDA-approved solution with substantial sales.
- Potential development of a solid dosage form for ART12.11 offers advantages in dosing, storage, and transport.
- Previous studies showed ART12.11 outperformed CBD in stress-induced anxiety and depression with lower CBD amounts.
- ART12.11 is in pre-clinical stages, moving towards optimized tablet formulation for clinical trials, indicating progress in drug development.
- Current data is pre-clinical, meaning ART12.11 has not yet been proven effective or safe in human trials.
- An unoptimized formulation was used, suggesting further development is necessary before clinical application.
- Comparative advantages are based on animal studies, which may not fully translate to human efficacy.
Insights
Artelo Biosciences has unveiled promising pre-clinical data comparing its novel cannabidiol (CBD) co-crystal formulation, ART12.11, to the well-established FDA-approved CBD drug, Epidiolex. While Epidiolex has generated over
The pharmaceutical research community will closely monitor the transition from pre-clinical to clinical trials. Should ART12.11 demonstrate superior efficacy and safety in humans, it could significantly impact the competitive landscape. A solid dosage form, preferred for adolescents and adults, could provide Artelo with a competitive edge over existing liquid formulations. However, it's essential to note that pre-clinical success doesn't always translate to clinical success.
Pharmacokinetic studies in both rats and dogs have shown confidence-building results, but investors should remain cautious until further clinical data is available. The company's strategy to develop an optimized tablet could reduce the pill burden and increase patient compliance, potentially enhancing market acceptance.
This development could lead to a broader application of CBD in clinical research and treatment, opening new business opportunities for Artelo. However, the journey from pre-clinical to market approval is fraught with regulatory hurdles and competition. Overall, the presented data are encouraging, but cautious optimism is warranted as the company progresses to the next development stages.
The presentation of ART12.11 at CT-CANN24 underscores a significant advancement for Artelo Biosciences in the CBD market. Given the comparable pharmacokinetics to Epidiolex, ART12.11 has the potential to challenge and possibly disrupt the market dominated by Epidiolex. The solid dosage form is likely to appeal more to adults and adolescents due to its ease of use, storage and precise dosing capabilities.
With Epidiolex's substantial revenue, ART12.11 could tap into a similarly lucrative market if it proves effective in clinical trials. The current market for CBD products is growing, with increasing acceptance and demand for cannabinoid-based therapies. This sets a favorable backdrop for ART12.11's potential entry.
However, investors should be mindful of the competitive landscape and the regulatory environment. The process of gaining market approval remains a significant hurdle. Artelo's ability to navigate these challenges effectively will determine its market success.
The company's previous data on ART12.11 showing improved properties and reduced pill burden are positive indicators. These factors could enhance patient adherence and acceptance, critical for market success. In summary, this news positions Artelo favorably within the CBD market, but the ultimate impact will hinge on successful clinical trials and regulatory approvals.
ART12.11 demonstrates comparable pharmacokinetics compared to Epidiolex®
SOLANA BEACH, Calif., May 29, 2024 (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, dermatologic and neurological conditions, today announced Dr. Andrew Yates presented new pre-clinical data on ART12.11 at the CT-CANN24 conference which is being held May 29-30, 2024 at the Hilton London Canary Wharf in London, UK.
The presentation, titled “An Aqueous Suspension of a Novel Cannabidiol: Tetramethylpyrazine Co-crystal, demonstrates a pharmacokinetic profile comparable with Epidiolex® in Rats,” highlights the Company’s patented cocrystal of CBD and TMP (tetramethylpyrazine), ART12.11, in an unoptimized formulation, demonstrated comparable pharmacokinetics of CBD and its metabolites to a mimic of Epidiolex, an FDA approved oral solution of CBD in ethanol and sesame oil used for controlling seizures in orphan childhood disorders with over
Andrew Yates, Ph.D., Chief Scientific Officer and Senior Vice President of Artelo, said “We are excited to present our first comparative data of ART12.11 versus an Epidiolex-like formulation of CBD to the cannabinoid research community. The data not only shows we can outperform an equivalent formulation of CBD but also that ART12.11 already has comparable CBD levels in plasma provided by Epidiolex. The data we have from both the rat and dog pharmacokinetic studies provide us confidence that we can design an optimized solid-dosage form for the clinic, that will open new frontiers for CBD clinical research in broader populations.”
As previously reported, ART12.11 offers improvements in physicochemical, pharmacokinetics, and pharmacodynamic properties compared to CBD. In addition, strong evidence previously announced with ART12.11 in an animal study of stress-induced anxiety and depression showed Artelo’s cocrystal composition outperformed CBD with just a third of the amount of CBD in the cocrystal than in the comparator arm of CBD alone. This data highlights Artelo’s opportunity to reduce the expected pill burden with its oral solid formulation and the Company is currently developing an optimized tablet of ART12.11 for planned clinical 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. Superior pharmaceutical properties, including physicochemical, pharmacokinetic, and pharmacodynamic advantages have been observed with ART12.11. Artelo believes a more consistent and improved bioavailability profile may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The US 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 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, 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.
About CT-CANN2024
CT-Cann2024 brings together leading researchers, clinicians, industry professionals and other related experts from around the globe to discuss ways of improving current research strategies, present new data and discoveries, and explore practical dilemmas and future avenues in this rapidly evolving field.
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
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