SOLANA BEACH, Calif. - Artelo Biosciences , Inc. (NASDAQ: NASDAQ:ARTL), a clinical-stage biopharmaceutical company, has received authorization from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1 clinical trial for its drug candidate ART26.12, aimed at treating chemotherapy-induced peripheral neuropathy (CIPN). The FDA's "Study May Proceed" letter marks a significant regulatory milestone, allowing the company to initiate its first-in-human studies.
ART26.12, a selective inhibitor of the Fatty Acid Binding Protein 5 (FABP5), is being developed as an orally delivered, non-opioid treatment option for CIPN—a condition for which there are currently no FDA-approved treatments. The drug is based on a proprietary FABP platform, targeting an intracellular protein involved in lipid signaling, which may play a role in various pathologies including cancer and pain.
The company has begun study startup activities in collaboration with Worldwide Clinical Trials, with results from the Phase 1 trial expected in the first half of 2025. ART26.12's development reflects Artelo Biosciences' broader commitment to leveraging lipid-modulating mechanisms to address diseases with significant unmet medical needs.
President and CEO Gregory D. Gorgas expressed confidence in the potential impact of ART26.12 on patient care, highlighting the drug's preclinical efficacy and robust patent estate. The company's FABP inhibitor platform has attracted interest from potential partners, signaling the industry's recognition of its therapeutic promise.
Chemotherapy-induced peripheral neuropathy is a debilitating condition that can arise during or after chemotherapy treatment, potentially leading to dose reductions or discontinuation of cancer therapy, which can adversely affect patient outcomes. A successful intervention for CIPN would not only alleviate pain but could also enable continued cancer treatment, improving efficacy and survival rates.
Artelo Biosciences' focus on modulating lipid-signaling pathways extends to a range of conditions beyond CIPN, including anorexia, anxiety, dermatologic issues, pain, and inflammation. The company's leadership team, comprised of experienced biopharmaceutical executives and in collaboration with respected researchers, is committed to advancing their product candidates through rigorous scientific and regulatory processes.
This information is based on a press release statement from Artelo Biosciences. The company's forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those projected. Investors are advised to exercise caution and not to place undue reliance on these forward-looking statements.
In other recent news, Artelo Biosciences presented promising pre-clinical data on its cannabinoid-based compound, ART12.11, indicating a pharmacokinetic profile comparable to the FDA-approved Epidiolex.
The company is developing an optimized tablet form of ART12.11, expected to offer precise dosing and easier storage, enhancing its appeal for future clinical studies. Artelo holds a U.S. patent for ART12.11 enforceable until December 2038, and the compound's improved bioavailability may increase safety and efficacy in human applications.
In addition to this, Artelo Biosciences highlighted the role of fatty acid binding protein 7 (FABP7) in various cancers, suggesting its potential as a target for cancer treatment. The company is developing a library of FABP inhibitor compounds, with the most advanced compound, ART26.12, showing promise in preclinical studies for cancer and related conditions.
Artelo plans to submit an investigational new drug application to the FDA in the second quarter of 2024 for the development of ART26.12 in chemotherapy-induced peripheral neuropathy.
These are key developments in Artelo Biosciences' ongoing efforts to address significant unmet medical needs with its product candidates. The company continues to focus on the development and commercialization of therapeutics that modulate lipid-signaling pathways for various conditions.
InvestingPro Insights
As Artelo Biosciences (NASDAQ: ARTL) embarks on the Phase 1 clinical trial for its CIPN drug candidate ART26.12, the company's financial health and market performance offer key insights for investors. With a modest market capitalization of $4.18 million, Artelo holds more cash than debt, indicating a solid balance sheet that can support its clinical development activities. This is a significant point for investors, as it suggests the company has the liquidity to fund its projects in the short term.
Despite the optimism surrounding the FDA's authorization, Artelo faces challenges, as reflected in its financial metrics. The company has a negative P/E ratio of -0.41, indicating that it is currently not profitable—a fact underscored by the InvestingPro Tips, which reveal that analysts do not expect the company to be profitable this year and project a drop in net income. Moreover, with a Return on Assets (ROA) at -66.62% for the last twelve months as of Q1 2024, the company's asset efficiency remains a concern.
Artelo's stock has experienced a downward trend, with a 1-year price total return of -34.6%, signaling investor caution. Still, the company has maintained a price of 43.45% of its 52-week high, which could indicate potential for recovery if the clinical trials demonstrate positive outcomes.
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