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

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Artelo Biosciences (Nasdaq: ARTL) has announced promising preclinical results for its drug candidate ART12.11, a CBD:TMP cocrystal, in treating stress-induced depression. The data, presented at the 35th Annual International Cannabinoid Research Society Symposium, demonstrates the drug's effectiveness comparable to sertraline (Zoloft) in treating depression-related behaviors.

Key findings show that ART12.11's 28-day treatment significantly improved depression-related behaviors in male rats, including restoration of hedonic and social behaviors. Notably, ART12.11 showed superior cognitive benefits compared to sertraline, successfully reversing stress-induced deficits in spatial and short-term memory without negative impacts on social memory.

Artelo Biosciences (Nasdaq: ARTL) ha annunciato risultati preclinici promettenti per il suo candidato farmaco ART12.11, un cocrystal di CBD:TMP, nel trattamento della depressione indotta da stress. I dati, presentati al 35° Simposio Annuale della International Cannabinoid Research Society, mostrano l'efficacia del farmaco paragonabile a quella della sertralina (Zoloft) nel trattamento dei comportamenti legati alla depressione.

I risultati principali evidenziano che il trattamento di 28 giorni con ART12.11 ha migliorato significativamente i comportamenti depressivi nei ratti maschi, inclusa la ripresa dei comportamenti edonici e sociali. In particolare, ART12.11 ha mostrato benefici cognitivi superiori rispetto alla sertralina, invertendo con successo i deficit indotti dallo stress nella memoria spaziale e a breve termine senza effetti negativi sulla memoria sociale.

Artelo Biosciences (Nasdaq: ARTL) ha anunciado resultados preclínicos prometedores para su candidato a medicamento ART12.11, un cocrystal de CBD:TMP, en el tratamiento de la depresión inducida por estrés. Los datos, presentados en el 35º Simposio Anual de la International Cannabinoid Research Society, demuestran que la eficacia del medicamento es comparable a la de la sertralina (Zoloft) en el tratamiento de comportamientos relacionados con la depresión.

Los hallazgos clave muestran que el tratamiento de 28 días con ART12.11 mejoró significativamente los comportamientos relacionados con la depresión en ratas macho, incluyendo la restauración de comportamientos hedónicos y sociales. Notablemente, ART12.11 mostró beneficios cognitivos superiores en comparación con la sertralina, revirtiendo con éxito los déficits inducidos por estrés en la memoria espacial y a corto plazo sin impactos negativos en la memoria social.

Artelo Biosciences (나스ë‹�: ARTL)ëŠ� 스트레스 유발 우울ì¦� 치료ë¥� 위한 약물 후보 ART12.11(CBD:TMP ì½”í¬ë¦¬ìФíƒ�)ì� 유ë§í•� ì „ìž„ìƒ� ê²°ê³¼ë¥� 발표했습니다. ì� ë°ì´í„°ëŠ” ì �35íš� êµ­ì œ 칸나비노ì´ë“œ 연구학회 ì—°ë¡€ 심í¬ì§€ì—�ì—서 발표ë˜ì—ˆìœ¼ë©°, 우울ì¦� ê´€ë � í–‰ë™ ì¹˜ë£Œì—서 세르트랄ë¦�(Zoloft)ê³� 비êµí•� 만한 약물ì� 효과ë¥� ë³´ì—¬ì¤ë‹ˆë‹�.

주요 ê²°ê³¼ì—� 따르ë©� ART12.11ì� 28ì� 치료ëŠ� 수컷 ì¥ì˜ 우울ì¦� ê´€ë � í–‰ë™ì� í¬ê²Œ 개선했으ë©�, ì¾Œë½ ë°� 사회ì � í–‰ë™ì� 회복ë� í¬í•¨ë˜ì–´ 있습니다. 특히 ART12.11ì€ ì„¸ë¥´íŠ¸ëž„ë¦°ì— ë¹„í•´ 우수í•� ì¸ì§€ì � ì´ì ì� ë³´ì—¬ 스트레스ë¡� 유발ë� 공간 ë°� 단기 기억 ì†ì‹¤ì� 성공ì ìœ¼ë¡� 회복시키면서 사회ì � 기억ì—는 부정ì ì� ì˜í–¥ì� 미치지 않았습니ë‹�.

Artelo Biosciences (Nasdaq : ARTL) a annoncé des résultats précliniques prometteurs pour son candidat médicament ART12.11, un cocrystal CBD:TMP, dans le traitement de la dépression induite par le stress. Les données, présentées lors du 35e Symposium annuel de l’International Cannabinoid Research Society, démontrent l’efficacité du médicament comparable à celle de la sertraline (Zoloft) dans le traitement des comportements liés à la dépression.

Les résultats clés montrent que le traitement de 28 jours avec ART12.11 a significativement amélioré les comportements liés à la dépression chez des rats mâles, incluant la restauration des comportements hédoniques et sociaux. Notamment, ART12.11 a montré des bénéfices cognitifs supérieurs par rapport à la sertraline, inversant avec succès les déficits induits par le stress dans la mémoire spatiale et à court terme sans impact négatif sur la mémoire sociale.

Artelo Biosciences (Nasdaq: ARTL) hat vielversprechende präklinische Ergebnisse für seinen Arzneimittelkandidaten ART12.11, ein CBD:TMP-Kokristall, bei der Behandlung von stressbedingter Depression bekannt gegeben. Die Daten, präsentiert auf dem 35. Jahreskongress der International Cannabinoid Research Society, zeigen die Wirksamkeit des Medikaments, die mit der von Sertralin (Zoloft) bei der Behandlung von depressionsbedingten Verhaltensweisen vergleichbar ist.

Wesentliche Erkenntnisse zeigen, dass die 28-tägige Behandlung mit ART12.11 depressive Verhaltensweisen bei männlichen Ratten signifikant verbesserte, einschließlich der Wiederherstellung von hedonistischen und sozialen Verhaltensweisen. Bemerkenswert ist, dass ART12.11 überlegene kognitive Vorteile im Vergleich zu Sertralin zeigte und stressbedingte Defizite im räumlichen und Kurzzeitgedächtnis erfolgreich umkehrte, ohne negative Auswirkungen auf das Sozialgedächtnis.

Positive
  • ART12.11 demonstrated efficacy comparable to leading SSRI sertraline (Zoloft) in treating depression
  • Superior cognitive restoration compared to sertraline, addressing a key limitation of existing SSRI therapies
  • Successful restoration of hedonic and social behaviors to near-baseline levels
  • Previous studies showed greater behavioral and pharmacokinetic results compared to CBD or Epidiolex
Negative
  • Results are still in preclinical stage, requiring further clinical validation
  • Study limited to male rats, requiring broader validation

Insights

Artelo's ART12.11 shows promising antidepressant efficacy in preclinical studies with cognitive advantages over existing SSRIs.

Artelo Biosciences' announcement of preclinical data for ART12.11 represents a significant milestone in their cannabinoid-based drug development pipeline. The patented CBD:TMP cocrystal demonstrated comparable efficacy to sertraline (Zoloft) in treating depression-like behaviors in a chronic stress animal model, while offering superior cognitive benefits � a critical differentiator in the antidepressant market.

The data presented at the ICRS Symposium highlights three key advantages: 1) ART12.11 matched sertraline in restoring hedonic and social behaviors, addressing core depression symptoms; 2) Unlike sertraline, it successfully reversed stress-induced deficits in spatial and short-term memory; and 3) These dual benefits position ART12.11 as potentially addressing an unmet medical need for depression treatments without cognitive side effects.

From a development perspective, this study builds on previous research showing ART12.11's superiority over CBD alone, but represents the first direct comparison against a leading SSRI. While these are early-stage results, the cognitive restoration element is particularly noteworthy as cognitive dysfunction remains a significant limitation with current antidepressants and affects patient quality of life and treatment adherence.

For Artelo's pipeline, these findings strengthen the therapeutic potential of their novel cocrystal technology platform. However, investors should recognize that significant development hurdles remain, including toxicology studies, clinical trials, and regulatory approval before ART12.11 could reach the multi-billion dollar antidepressant market.

ART12.11, the Patented CBD:TMP Cocrystal, Demonstrates Potent Antidepressant-Like Activity and Cognitive Benefits Over Leading SSRI

Data Being Presented at the 35th Annual International Cannabinoid Research Society Symposium

SOLANA BEACH, Calif., July 07, 2025 (GLOBE NEWSWIRE) -- 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 , 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. The ICRS Symposium is being held July 6-10, 2025 in Bloomington, IN. Interested parties may follow  on X. 

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s future investment policy of its excess capital, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,� “anticipate,� “intend,� “plan,� “believe,� “estimate,� “potential,� “predict,� “project,� “should,� “would� and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission, including our ability to raise additional capital in the future. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by applicable securities laws.

Investor Relations Contact:
Crescendo Communications, LLC
Tel: 212-671-1020
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FAQ

What are the key findings of Artelo Biosciences' (ARTL) ART12.11 preclinical trial?

ART12.11 showed antidepressant efficacy comparable to sertraline (Zoloft), with superior cognitive benefits. The 28-day treatment significantly improved depression-related behaviors and reversed stress-induced memory deficits in male rats.

How does ART12.11 compare to existing SSRI antidepressants?

ART12.11 matched sertraline's effectiveness in treating depression symptoms but demonstrated superior cognitive restoration, particularly in spatial and short-term memory, addressing a known limitation of existing SSRI therapies.

What makes Artelo's ART12.11 different from other antidepressant treatments?

ART12.11 is a novel CBD:TMP cocrystal that offers a dual-action profile, combining antidepressant effects with cognitive benefits. Unlike traditional SSRIs, it can reverse cognitive deficits while treating depression symptoms.

What is the potential market impact for Artelo Biosciences' ART12.11?

ART12.11 is positioned to compete in the multi-billion-dollar antidepressant market, with potential differentiation through its combined mood-lifting and cognitive benefits compared to existing treatments.

When did Artelo Biosciences present the ART12.11 preclinical results?

The results were presented on July 7, 2025 at the 35th Annual International Cannabinoid Research Society Symposium in Bloomington, Indiana.
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