Artelo Biosciences Receives Favorable UK MHRA Guidance for a Phase 1 Trial of ART12.11, the Company’s Proprietary CBD:TMP Cocrystal Being Developed for the Treatment of Anxiety and Depression

Core Insights - Artelo Biosciences has received positive feedback from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) regarding the development of ART12.11, a novel cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP) [1][2][4] - The MHRA has indicated that ART12.11 may qualify for the Innovative Licensing and Access Pathway (ILAP), which could accelerate its development and patient access [3][4] Regulatory Feedback - The MHRA supports a streamlined clinical trial application based on existing nonclinical and clinical evidence for CBD and TMP, providing a clear path for the first-in-human (FIH) study design [2] - The proposed FIH study design is a single-dose, multi-formulation crossover study, deemed methodologically sound for characterizing ART12.11's pharmacokinetic profile [2] Development Strategy - The company plans to evaluate a formal application for ART12.11 to enter the ILAP, aligning with the program's criteria to address unmet needs in anxiety and depression [3] - The regulatory assurance from the MHRA is expected to reduce expenses for the ART12.11 program and potentially extend market exclusivity until the end of 2038 due to existing patents [5] Product Profile - ART12.11 is a proprietary cocrystal composition that has shown improved pharmacokinetics and efficacy compared to other forms of CBD in nonclinical studies [6] - The cocrystal has demonstrated efficacy comparable to sertraline (Zoloft) in preclinical depression models and superior cognitive restoration compared to leading SSRIs [4] Company Overview - Artelo Biosciences is focused on developing therapeutics that modulate lipid-signaling pathways to address significant unmet medical needs across various conditions, including cancer, anxiety, and pain [8]