Artelo Biosciences Announces Positive Preclinical Efficacy with ART12.11 in Stress-Induced Depression Model

SOLANA BEACH, Calif., Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological or neurological conditions, today announced the presentation of compelling new preclinical data on its Cannabidiol (CBD) and Tetramethylpyrazine (TMP) cocrystal drug candidate, ART12.11, at the 35th Annual International Cannabinoid Research Society (ICRS) Symposium, taking place July 6–10 in Bloomington, Indiana.

The poster, titled “ART12.11, A Novel Cannabidiol:Tetramethylpyrazine Cocrystal, Alleviates Stress-Induced Depressive Symptoms,” is being presented today by Matt Jones, a scientist working in the laboratory of Professor Steven Laviolette at the University of Western Ontario, Canada. The data highlight ART12.11’s unique dual-action profile in improving depression-related behaviors in animals and reversing cognitive deficits associated with chronic stress. These are key differentiators that position ART12.11 as a potential next-generation treatment candidate in the multi-billion-dollar antidepressant market.

Highlights:

• Robust Antidepressant-like Effects: A 28-day treatment regimen with ART12.11 significantly reversed behavioral impairments in male rats exposed to chronic stress. The data with ART12.11 demonstrated efficacy on par with sertraline (Zoloft), a leading selective serotonin reuptake inhibitor (SSRI).
• Restoration of Hedonic and Social Behaviors: Like sertraline, ART12.11 improved sucrose preference and social motivation, which are established behavioral markers of depressive-like states, to near-baseline levels.
• Superior Cognitive Restoration: Unlike sertraline, ART12.11 reversed stress-induced deficits in both spatial and short-term memory without negatively impacting social memory.
• Differentiated Therapeutic Profile: These findings underscore ART12.11’s potential as a highly differentiated candidate for treating depression and anxiety, especially in patients where cognitive dysfunction occurs, which is a known limitation of existing SSRI therapies.

“Our latest behavioral studies suggest that the cocrystal holds strong potential as a novel antidepressant. In a stressed rodent model, ART12.11 significantly restored key depression-related behaviors to baseline levels. The ability to experience pleasure and social motivation with ART12.11 were comparable to the effects of the established antidepressant sertraline. Notably, ART12.11 also reversed stress-induced cognitive impairments, which is an area where sertraline was not as effective,” said Matt Jones, the lead researcher of this work at the University of Western Ontario.

Prior preclinical research studies in animals with ART12.11 demonstrated greater behavioral and pharmacokinetic results compared to CBD or Epidiolex. These new findings observed in Dr. Laviolette’s laboratory are from the first preclinical study that compared ART12.11 to a leading SSRI.

“Although strong antidepressant effects were noted with ART12.11 in prior studies, we are especially encouraged by these comparative findings,” said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “We believe ART12.11 has the potential to meet a critical need in the mental health landscape by delivering both mood-lifting and cognitive benefits. which could set ART12.11 apart from existing antidepressants.”

About ART12.11
ART12.11 is Artelo’s wholly owned, proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). Isolated as a single crystalline form, ART12.11 has exhibited better pharmacokinetics and improved efficacy compared to other forms of CBD in nonclinical studies. Superior pharmaceutical properties, including physicochemical, pharmacokinetic, and pharmacodynamic advantages have been observed with ART12.11. Artelo believes a more consistent and improved bioavailability profile may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The US issued composition of matter patent for ART12.11 is enforceable until December 10, 2038 and has now been granted or validated in 19 additional countries.

About Artelo Biosciences
Artelo Biosciences, Inc. is a clinical-stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the Company applies leading-edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and X: @ArteloBio.

About the International Cannabinoid Research Society
The International Cannabinoid Research Society (ICRS) is the premier global scientific association with more than 650 international members from 40 countries, all active researchers in the field of endogenous, plant-derived, and synthetic cannabinoids and related bioactive lipids. In addition to acting as a source for impartial information on cannabis and the cannabinoids, the main role of the ICRS is to provide an open forum for researchers to meet and discuss their research.