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SOLANA BEACH, Calif. - Artelo Biosciences, Inc. (NASDAQ:ARTL), a small-cap biotech company with a market capitalization of $3.7 million and a strong balance sheet showing more cash than debt, announced favorable results from its first-in-human study of ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5 (FABP5) being developed for pain management. According to InvestingPro data, the company maintains a healthy debt-to-equity ratio of 0.15.
The Phase 1 Single Ascending Dose study, which enrolled 49 healthy volunteers, demonstrated a promising safety profile with all adverse events classified as mild, transient, and self-resolving. No drug-related adverse events were observed in the blinded dataset, according to the company’s press release statement. The positive news has contributed to Artelo’s strong market performance, with InvestingPro data showing a 15.5% return over the past week.
The study also showed predictable pharmacokinetics with dose-dependent, linear absorption across the evaluated range, and established a wide safety margin between estimated therapeutic plasma concentrations and the highest exposure levels achieved.
ART26.12 is the first orally administered, selective FABP5 inhibitor to be evaluated in humans. The compound works by modulating endogenous lipid signaling molecules that exert analgesic effects through established pathways.
"We are greatly encouraged with the results of the SAD study with our lead FABP5 inhibitor," said Andrew Yates, Senior Vice President and Chief Scientific Officer at Artelo.
The company plans to commence a Multiple Ascending Dose study in the fourth quarter of 2025 to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing.
Artelo is initially developing the compound for chemotherapy-induced peripheral neuropathy, targeting the growing chronic pain therapeutics market, which exceeded $97 billion globally in 2023.
The development aligns with the FDA’s Overdose Prevention Framework, which encourages the development of non-opioid analgesics for pain management.
In other recent news, Artelo Biosciences has raised approximately $1.425 million through a private placement, issuing shares and warrants to support clinical trials for its drug candidates ART26.12 and ART27.13. This funding will also be used for general corporate purposes and to purchase SOL digital currency. Additionally, Artelo Biosciences announced a 6-for-1 reverse stock split, effective June 13, 2025, aimed at meeting Nasdaq’s minimum bid price requirement. Following this corporate action, the company will have approximately 546,667 shares outstanding, with all outstanding warrants and derivatives adjusted accordingly. D. Boral Capital downgraded Artelo’s stock from Buy to Hold, expressing caution about the reverse split and noting limited near-term upside. Furthermore, Artelo presented promising data at the British Pain Conference on its FABP inhibitor ART26.12, showcasing its potential as a treatment for osteoarthritis pain. The study highlighted the drug’s effectiveness in a surgical rat model, with results comparable to naproxen but with fewer side effects. Initial Phase 1 trial results for ART26.12 are expected in the second quarter of 2025, focusing on chemotherapy-induced peripheral neuropathy.
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