Artelo reports positive Phase 1 results for novel pain treatment

Published 30/06/2025, 12:50
Artelo reports positive Phase 1 results for novel pain treatment

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.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.