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Artelo Biosciences receives MHRA guidance for Phase 1 trial of ART12.11

Artelo Biosciences (ARTL) has received written scientific advice from the UK’s Medicines and Healthcare products Regulatory Agency on the nonclinical development and first-in-human clinical study plans for ART12.11, a novel cocrystal of Cannabidiol and Tetramethylpyrazine. The MHRA agreed that reliance on the substantial body of historic nonclinical and clinical evidence for CBD, alongside legacy data for TMP, provides a scientifically justified basis for a streamlined clinical trial application-enabling nonclinical development plan of the cocrystal combination to support the proposed FIH study, with clear guidance for achieving the agreed-upon FIH study design for ART12.11. The agency also affirmed that the proposed first-in-human study design-a single-dose, multi-formulation crossover study-was methodologically sound for characterizing ART12.11’s pharmacokinetic profile. Importantly, the MHRA offered constructive and specific guidance for completing the data package supporting the agreed-upon Phase 1 trial. Additionally, the agency proposed that ART12.11 may be a candidate for the Innovative Licensing and Access Pathway. ILAP offers a unique opportunity to accelerate the development and patient access of new therapies through early and sustained collaboration with the MHRA, National Health Service, and health technology assessment bodies. Given ART12.11’s novel mechanism and potential to address unmet needs in anxiety and depression, Artelo believes the program aligns well with ILAP’s criteria and will evaluate a formal application to enter the pathway in the coming months. Multiple nonclinical studies with ART12.11 have shown its promising profile compared to an antidepressant or CBD alone. The Company recently announced positive preclinical results in a depression model comparing ART12.11 with sertraline, a selective serotonin reuptake inhibitor, where Artelo’s patented CBD:TMP cocrystal demonstrated efficacy on par with sertraline and showed superior cognitive restoration compared to the leading SSRI. Additionally, in a rodent model of stress-induced anxiety and depression, where ART12.11 was compared to CBD dosed at 300% the amount of CBD contained in the oral tablet of ART12.11, the CBD:TMP cocrystal demonstrated efficacy where CBD alone did not.

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