Artelo Biosciences Announces Promising New Data on Novel Non-Opioid Treatment Approach for Osteoarthritis Pain at the 13th Annual Musculoskeletal Repair and Regeneration Symposium
Artelo Biosciences (ARTL) presented new data on ART26.12, their lead clinical Fatty Acid Binding Protein 5 (FABP5) inhibitor, for osteoarthritis (OA) pain treatment. In preclinical studies at Stony Brook University, ART26.12 showed superior symptom relief compared to naproxen in a surgical rodent OA model, demonstrating significant improvement in weight-bearing across all tested doses. The compound exhibited a clear dose-response relationship, with higher concentrations providing better pain relief.
The FDA has cleared ART26.12 for its first-in-human Phase 1 single ascending dose study, with initial results expected in H1 2025. The treatment targets over 500 million people globally affected by OA, according to WHO, and represents a potential alternative to NSAIDs and opioids.
Artelo Biosciences (ARTL) ha presentato nuovi dati su ART26.12, il principale inibitore della proteina legante gli acidi grassi 5 (FABP5) per il trattamento del dolore da osteoartrite (OA). Negli studi preclinici condotti presso la Stony Brook University, ART26.12 ha dimostrato un alleviamento dei sintomi superiore rispetto al naprossene in un modello di OA su roditori sottoposti a intervento chirurgico, mostrando un miglioramento significativo nel peso supportato a tutte le dosi testate. Il composto ha mostrato una chiara relazione dose-risposta, con concentrazioni più elevate che fornivano un miglior sollievo dal dolore.
La FDA ha autorizzato ART26.12 per il suo primo studio clinico di Fase 1 a dose singola crescente, con risultati iniziali previsti per il primo semestre del 2025. Il trattamento si rivolge a oltre 500 milioni di persone nel mondo colpite da OA, secondo l'OMS, e rappresenta una potenziale alternativa agli NSAID e agli oppioidi.
Artelo Biosciences (ARTL) presentó nuevos datos sobre ART26.12, su principal inhibidor de la proteína transportadora de ácidos grasos 5 (FABP5) para el tratamiento del dolor por osteoartritis (OA). En estudios preclínicos en la Universidad de Stony Brook, ART26.12 mostró un alivio de síntomas superior en comparación con el naproxeno en un modelo quirúrgico de OA en roedores, demostrando una mejora significativa en el peso soportado en todas las dosis probadas. El compuesto exhibió una clara relación dosis-respuesta, con concentraciones más altas proporcionando un mejor alivio del dolor.
La FDA ha autorizado ART26.12 para su estudio en humanos de Fase 1 con dosis ascendentes únicas, con resultados iniciales esperados para el primer semestre de 2025. El tratamiento tiene como objetivo a más de 500 millones de personas en todo el mundo afectadas por OA, según la OMS, y representa una alternativa potencial a los AINEs y opioides.
Artelo Biosciences (ARTL)는 골관절염(OA) 통증 치료를 위한 주요 임상 지방산 결합 단백질 5(FABP5) 억제제인 ART26.12에 대한 새로운 데이터를 발표했습니다. 스토니 브룩 대학교에서 진행된 전임상 연구에서 ART26.12는 외과적 쥐 OA 모델에서 나프록센에 비해 우수한 증상 완화를 보여주었으며, 모든 시험된 용량에서 체중 지지의 유의미한 개선을 나타냈습니다. 이 화합물은 명확한 용량-반응 관계를 보였으며, 더 높은 농도가 더 나은 통증 완화를 제공했습니다.
FDA는 ART26.12의 첫 인간 대상 1상 단일 상승 용량 연구를 승인했으며, 초기 결과는 2025년 상반기에 예정되어 있습니다. 이 치료법은 WHO에 따르면 OA에 영향을 받는 전 세계 5억 명 이상의 사람들을 대상으로 하며, NSAID와 오피오이드에 대한 잠재적 대안을 제시합니다.
Artelo Biosciences (ARTL) a présenté de nouvelles données sur ART26.12, leur principal inhibiteur de la protéine liant les acides gras 5 (FABP5), pour le traitement de la douleur liée à l'arthrose (OA). Dans des études précliniques réalisées à l'Université de Stony Brook, ART26.12 a montré un soulagement des symptômes supérieur à celui du naproxène dans un modèle chirurgical d'OA sur des rongeurs, démontrant une amélioration significative du poids supporté à toutes les doses testées. Le composé a montré une relation claire dose-réponse, avec des concentrations plus élevées offrant un meilleur soulagement de la douleur.
La FDA a autorisé ART26.12 pour son étude de phase 1 à dose unique croissante chez l'homme, avec des résultats initiaux attendus au premier semestre 2025. Ce traitement cible plus de 500 millions de personnes dans le monde touchées par l'OA, selon l'OMS, et représente une alternative potentielle aux AINS et aux opioïdes.
Artelo Biosciences (ARTL) hat neue Daten zu ART26.12 vorgestellt, ihrem führenden klinischen Inhibitor des Fett-Säure-bindenden Proteins 5 (FABP5) zur Behandlung von Schmerzen bei Osteoarthritis (OA). In präklinischen Studien an der Stony Brook University zeigte ART26.12 eine überlegene Linderung der Symptome im Vergleich zu Naproxen in einem chirurgischen OA-Modell bei Nagetieren und demonstrierte eine signifikante Verbesserung des gewichttragenden Verhaltens in allen getesteten Dosen. Die Verbindung zeigte eine klare Dosis-Wirkungs-Beziehung, wobei höhere Konzentrationen eine bessere Schmerztherapie boten.
Die FDA hat ART26.12 für die erste Phase-1-Studie mit aufsteigenden Einzelgaben in Menschen freigegeben, wobei erste Ergebnisse für das erste Halbjahr 2025 erwartet werden. Die Behandlung zielt auf über 500 Millionen Menschen weltweit ab, die laut WHO von OA betroffen sind, und stellt eine potenzielle Alternative zu NSAIDs und Opioiden dar.
- ART26.12 demonstrated superior efficacy compared to naproxen in preclinical OA studies
- FDA clearance received for Phase 1 clinical trials
- Clear dose-response relationship observed in preclinical studies
- Potential market of over 500 million OA patients globally
- Initial clinical results not expected until first half of 2025
- Still in early development stages with only preclinical data available
Insights
The preclinical data for ART26.12 in osteoarthritis pain represents a significant milestone. The compound showed superior efficacy compared to naproxen, with improved weight-bearing outcomes across all three doses tested. The clear dose-response relationship and faster onset than naproxen are particularly noteworthy technical achievements.
The target market is substantial, with over 500 million people affected by osteoarthritis globally. The novel mechanism of action through FABP5 inhibition, affecting cytokine and chemokine expression, differentiates it from current treatments. With seven successful preclinical pain studies completed and FDA clearance for Phase 1 trials, the development pathway is progressing systematically.
However, investors should note that Phase 1 results aren't expected until first half of 2025 and successful preclinical results don't guarantee clinical success. The NIH HEAL Initiative inclusion adds credibility but doesn't accelerate the lengthy clinical development timeline ahead.
ART26.12, the Company’s Lead Clinical Fatty Acid Binding Protein 5 Inhibitor, Continues to Show Positive Preclinical Results in Multiple Pain Studies
SOLANA BEACH, Calif., Nov. 13, 2024 (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, dermatologic and neurological conditions, announced new data being presented today on ART26.12, Artelo’s lead clinical Fatty Acid Binding Protein 5 (FABP5) inhibitor, in osteoarthritis (OA) pain at the 13th Annual Musculoskeletal Repair and Regeneration Symposium in New York. This evidence adds OA pain to the list of pain types such as neuropathic and cancer bone pain where ART26.12 has shown potential as an analgesic with a novel mechanism of action.
In this new research conducted at Stony Brook University, ART26.12 demonstrated more responsive symptom relief in a surgical rodent OA model than naproxen, a commonly used nonsteroidal anti-inflammatory drug (NSAID) in the treatment of OA. ART26.12 significantly improved weight-bearing on affected limbs at all three doses studied, indicating a reduction in OA-induced pain. Importantly, ART26.12 demonstrated a clear dose-response relationship, with higher concentrations yielding greater pain relief and more rapid responses than naproxen.
The study, entitled “Fatty Acid Binding Protein 5 Inhibitor, ART26.12, is a Novel Analgesic for Osteoarthritis Pain,” was conducted by the Department of Orthopedics and Rehabilitation and the Department of Anesthesiology at the Renaissance School of Medicine at Stony Brook University by Drs. Kai Bou, Adam Bruzzese, Kaitlin Farrell, Chris Gordon, David Komatsu and Martin Kaczocha. “We are encouraged by these behavioral data showing efficacy for ART26.12 in alleviating osteoarthritis pain,” said Dr. Komatsu of Stony Brook University. “Furthermore, we are dedicated to completing our remaining analyses to gain a comprehensive understanding of the biological response to this promising compound.”
According to the World Health Organization, OA affects over 500 million people globally. Symptoms of OA include joint debilitation and persistent, extreme pain. Artelo’s research continues with a focus on long-term efficacy, currently evaluating the effects of four weeks of repeated dosing of ART26.12 on pain behaviors as well as knee structures and joint degradation. ART26.12 operates through a novel lipid-signaling pathway by inhibiting FABP5, which reduces cytokine and chemokine expression linked to OA pain. Preclinical efficacy has already been seen in both single and repeat dosing scenarios suggesting potential for both acute and chronic OA pain management.
Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences, added, “This new OA research constitutes our seventh preclinical study in pain, all of which show ART26.12’s potential as an innovative alternative to NSAIDs and opioids for some of the most severe pain management challenges.”
The U.S. Food and Drug Administration (FDA) cleared ART26.12 to initiate for its first-in-human Phase 1 single ascending dose study with initial results anticipated during the first half of 2025. As previously reported, ART26.12 has also been accepted into the NIH Helping to End Addiction Long Term Initiative’s Preclinical Screening Platform for Pain which seeks to accelerate development of non-opioid, non-addictive treatment options for pain management.
About ART26.12
ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) cleared by the FDA to initiate first-in-human studies, is a potent and selective inhibitor of FABP5 being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic, with initial clinical development planned for chemotherapy-induced peripheral neuropathy (CIPN). Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. FABP is overexpressed and associated with abnormal lipid signaling in a number of pathologies. Beyond ART26.12 in CIPN, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders.
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 Twitter: @ArteloBio.
About Stony Brook University
Stony Brook University, New York’s flagship university and No. 1 public university, was established in 1957 as a college for the preparation of secondary school teachers of mathematics and science. Stony Brook is part of the State University of New York (SUNY) system. The university has grown tremendously and is now recognized as one of the nation’s important centers of learning and scholarship.
Forward Looking Statements
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Investor Relations Contact:
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Email: ARTL@crescendo-ir.com
FAQ
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