ART12.11
New Preclinical Data on ART12.11 for the Treatment of Mood and Anxiety Disorders
New research reveals ART12.11, a cannabidiol:tetramethylpyrazine cocrystal, significantly enhances mood regulation, outperforming traditional cannabidiol in treating mood and anxiety disorders.
Artelo Biosciences today announced the publication of new preclinical data on ART12.11, its proprietary cannabidiol:tetramethylpyrazine (CBD:TMP) cocrystal. ART12.11 significantly outperformed cannabidiol (CBD) alone in reducing stress-induced depression and anxiety symptoms, and also achieved superior oral bioavailability.
“In our recent study, we found that ART12.11 produced promising anti-depressant- and anti-anxiety-like effects. Our results suggest that ART12.11 works by selectively influencing serotonergic activity and endocannabinoid signaling—key pathways in mood regulation—while leaving other systems largely unaffected. This selectivity may help maximize therapeutic benefits while minimizing side effects,” said Matt Jones, the lead researcher of the study at the University of Western Ontario.
Investigators found that ART12.11 reversed stress-induced behavioral deficits and produced robust antidepressant and anxiolytic-like effects. These benefits were superior to CBD alone, TMP alone, or a noncrystalline mixture of CBD and TMP. Additionally, oral administration of ART12.11 resulted in higher plasma concentrations of CBD and its major metabolite, highlighting that ART12.11 has improved pharmacokinetic properties over conventional CBD formulations. ART12.11 also enhanced activation of the endocannabinoid and serotonergic systems in critical brain regions for mood regulation, such as the prefrontal cortex, ventral hippocampus, and nucleus accumbens. The peer-reviewed study, which was conducted in collaboration with researchers at Western Ontario University, was published in Progress in Neuro-Psychopharmacology and Biological Psychiatry.
According to these results ART12.11 could be posed to fill the market gaps for mood and anxiety disorders, as conventional CBD, due to its inconsistent efficacy and poor bioavailability, has had limited clinical adoption. By addressing these shortcomings, ART12.11 may represent a significant advancement in cannabinoid-based therapeutics for anxiety and depression disorders.
The UK regulatory authority Medicines and Healthcare products Regulatory Agency (MHRA) has agreed that Artelo may rely on the substantial body and sufficient nonclinical and clinical evidence for CBD and may leverage the legacy data for TMP, which could provide a scientifically justified basis for its clinical trial application. Additionally, guidance from the MHRA will help in streamlining the nonclinical development plan for ART12.11, which should reduce costs and enable rapid advancement towards the proposed first human ART12.11 study planned for 2026.
