Artelo Biosciences stock surges after receiving favorable UK regulatory guidance

Published 01/08/2025, 12:58
© Reuters.

Investing.com -- Artelo Biosciences (NASDAQ:ARTL) stock surged 18% after the company received favorable guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for a Phase 1 trial of its proprietary CBD:TMP cocrystal being developed for anxiety and depression treatment.

The clinical-stage pharmaceutical company announced that the MHRA agreed to a streamlined clinical trial application process for ART12.11, a novel cocrystal combining Cannabidiol (CBD) and Tetramethylpyrazine (TMP). The regulatory body affirmed that Artelo’s proposed first-in-human study design—a single-dose, multi-formulation crossover study—was methodologically sound for characterizing the drug’s pharmacokinetic profile.

Notably, the MHRA suggested that ART12.11 may qualify for the Innovative Licensing and Access Pathway (ILAP), which could accelerate development and patient access through early collaboration with UK health authorities. The company plans to evaluate a formal ILAP application in the coming months.

"It’s gratifying to receive this positive feedback and actionable recommendations from the MHRA, which provides a clear path forward as we prepare to initiate clinical studies with ART12.11," said Dr. Andrew Yates, Chief Scientific Officer at Artelo.

The company recently reported positive preclinical results where ART12.11 demonstrated efficacy comparable to sertraline (Zoloft) in a depression model, with superior cognitive restoration compared to the SSRI. In another study, the cocrystal showed efficacy in a rodent model of stress-induced anxiety and depression where CBD alone did not.

Gregory Gorgas, President & CEO at Artelo, noted that the regulatory guidance is expected to reduce expenses and potentially accelerate development, with patents valid in 20 countries through 2038. The company aims to begin clinical trials with ART12.11 in early 2025.

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.