Artelo Biosciences stock surges after receiving favorable UK regulatory guidance

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.

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