Artelo Biosciences Announces Presentation of Positive Interim Phase 2 CAReS Data on ART27.13 at the 2025 Cancer Cachexia Society Conference
Artelo Biosciences (Nasdaq: ARTL) presented positive interim Phase 2 CAReS data for ART27.13 at the 2025 Cancer Cachexia Society Conference. The drug, targeting cancer anorexia-cachexia syndrome (CACS), demonstrated significant benefits in key metrics:
Patients receiving the highest dose (1300 µg) achieved an average +6% weight gain over 12 weeks, while placebo patients lost ~5%. The treatment showed improvements in lean body mass and increased daily activity levels, confirmed through digital wearable data. The drug maintained a favorable safety profile with mostly mild to moderate adverse events and no serious drug-related incidents.
Professor Barry Laird from Oslo University Hospital presented the data, while the company engaged in partnering discussions to advance the program's commercial potential.
Artelo Biosciences (Nasdaq: ARTL) ha presentato dati interinali positivi di fase 2 CAReS per ART27.13 alla conferenza 2025 della Cancer Cachexia Society. Il farmaco, mirato alla sindrome da anoressia-cachexia legata al cancro (CACS), ha mostrato benefici significativi in metriche chiave:
I pazienti che hanno ricevuto la dose più alta (1300 µg) hanno registrato in media un aumento di peso di +6% in 12 settimane, mentre i pazienti del placebo hanno avuto una perdita di circa il 5%. Il trattamento ha migliorato la massa magra e i livelli di attività quotidiana, confermati anche dai dati provenienti da dispositivi indossabili digitali. Il farmaco ha mantenuto un profilo di sicurezza favorevole con eventi avversi per lo più lievi o moderati e nessun evento grave correlato al farmaco.
Il professor Barry Laird dell'Oslo University Hospital ha presentato i dati, mentre l'azienda ha avviato discussioni di partenariato per valorizzare ulteriormente il potenziale commerciale del programma.
Artelo Biosciences (Nasdaq: ARTL) presentó datos interinos positivos de la fase 2 CAReS para ART27.13 en la Conferencia 2025 de la Cancer Cachexia Society. El fármaco, dirigido a la síndrome de anorexia-cachexia asociada al cáncer (CACS), mostró beneficios significativos en métricas clave:
Los pacientes que recibieron la dosis más alta (1300 µg) lograron un aumento medio de peso de +6% en 12 semanas, mientras que los pacientes del grupo placebo perdieron alrededor del 5%. El tratamiento mostró mejoras en la masa magra y en los niveles de actividad diaria, confirmadas también por datos de dispositivos wearables digitales. El fármaco mantuvo un perfil de seguridad favorable con eventos adversos mayormente leves a moderados y sin incidentes graves relacionados con el fármaco.
El profesor Barry Laird del Oslo University Hospital presentó los datos, mientras la empresa estaba en conversaciones de asociación para impulsar el potencial comercial del programa.
Artelo Biosciences (Nasdaq: ARTL)는 2025년 Cancer Cachexia Society 회의에서 ART27.13의 2상 CAReS 중간 데이터를 발표했습니다. 암 관련 식욕부진-악액질 증후군(CACS)을 표적으로 하는 이 약은 핵심 지표에서 유의미한 이점을 보였습니다:
가장 높은 용량(1300 µg)을 투여받은 환자는 12주 동안 평균 체중이 +6% 증가했고, 위약군은 약 -5%를 기록했습니다. 치료는 근육량 증가와 일일 활동성 증가를 보여주었으며, 디지털 웨어러블 데이터로도 확인되었습니다. 이 약은 안전성 프로필이 양호하게 유지되었고, 대부분 경증에서 중등도 수준의 부작용이 있었으며 약물 관련 심각한 사건은 없었습니다.
오슬로 대학병원(Oslo University Hospital)의 Barry Laird 교수가 데이터를 발표했고, 기업은 프로그램의 상업적 가능성을 높이기 위한 파트너링 논의를 진행했습니다.
Artelo Biotechnologies (Nasdaq: ARTL) a présenté des données intermédiaires positives de phase 2 CAReS pour ART27.13 lors de la conférence 2025 de la Cancer Cachexia Society. Le médicament, ciblant le syndrome anorexie-cachexie lié au cancer (CACS), a démontré des bénéfices significatifs sur des critères clés :
Les patients ayant reçu la dose la plus élevée (1300 µg) ont enregistré une augmentation moyenne de poids de +6% en 12 semaines, tandis que les patients placebo ont perdu environ 5%. Le traitement a montré des améliorations de la masse corporelle maigre et une augmentation des niveaux d'activité quotidienne, confirmées par des données issues de capteurs portables numériques. Le médicament a conservé un profil de sécurité favorable avec des événements indésirables principalement légers à modérés et aucun événement grave lié au médicament.
Le professeur Barry Laird de l'hôpital universitaire d'Oslo a présenté les données, tandis que l'entreprise menait des discussions de partenariat pour faire progresser le potentiel commercial du programme.
Artelo Biosciences (Nasdaq: ARTL) präsentierte positive Zwischenergebnisse der Phase-2-CAReS-Daten für ART27.13 auf der Konferenz der Cancer Cachexia Society 2025. Das Arzneimittel, das auf das cancerbedingte Appetit- und Gewichtsverlust-Syndrom (CACS) abzielt, zeigte bei Schlüsselparametern signifikante Vorteile:
Patienten, die die Höchstdosis (1300 µg) erhielten, verzeichneten über 12 Wochen einen durchschnittlichen Gewichtszuwachs von +6%, während Placebo-Patienten ca. -5% verloren. Die Behandlung zeigte Verbesserungen der Lean Body Mass und eine Zunahme der täglichen Aktivität, bestätigt durch digitale Wearable-Daten. Das Arzneimittel behielt ein günstiges Sicherheitsprofil bei, mit überwiegend leichten bis moderaten Nebenwirkungen und keinen schweren, arzneimittelbezogenen Ereignissen.
Professor Barry Laird vom Oslo University Hospital stellte die Daten vor, während das Unternehmen Verhandlungen über Partnerschaften führte, um das kommerzielle Potenzial des Programms voranzutreiben.
Artelo Biosciences (Nasdaq: ARTL) قدمت بيانات وسيطة إيجابية من المرحلة الثانية CAReS لـ ART27.13 في مؤتمر Cancer Cachexia Society لعام 2025. الدواء المستخدم لاستهداف متلازمة فقدان الشهية وهزال السرطان (CACS) أظهر فوائد كبيرة في المقاييس الرئيسية:
المرضى الذين تلقوا أعلى جرعة (1300 ميكروغرام) حققوا زيادة في الوزن بمقدار +6% خلال 12 أسبوعًا، بينما خسر مرضى الدواء الوهمي حوالي 5%. أظهرت المعالجة تحسنًا في كتلة الجسم الخالية من الدهون وزيادة في مستويات النشاط اليومي، وتأكيد ذلك من خلال بيانات الأجهزة القابلة للارتداء الرقمية. حافظ الدواء على ملف أمان مفضل مع أحداث جانبية في الغالب خفيفة إلى متوسطة، وبدون حوادث خطيرة مرتبطة بالدواء.
قدم الأستاذ باري لارد من مستشفى أوسلو الجامعي البيانات، بينما أجرت الشركة مناقشات شراكة لتعزيز الإمكانات التجارية للبرنامج.
Artelo Biosciences (Nasdaq: ARTL) 在 2025 年癌症恶病质学会会议上公布了 ART27.13 的阶段 2 CAReS 中期数据，结果积极。该药物针对癌症相关厌食-恶病质综合征 (CACS)，在关键指标上显示出显著获益：
接受最高剂量（1300 µg）的患者在 12 周内平均体重增加 +6%，而安慰剂组下降约 5%。治疗还改善了瘦体重并提高日常活动水平，数字可穿戴设备的数据也予以证实。该药物保持了有利的安全性特征，绝大多数不良事件为轻到中度，未出现与药物相关的严重事件。
奥斯陆大学医院的 Barry Laird 教授介绍了数据，公司则在推进该项目的商业潜力方面进行伙伴关系洽谈。
- None.
- Results are interim, not final Phase 2 data
- Commercial partnerships still under discussion, not secured
Insights
Artelo's ART27.13 shows significant clinical benefits in cancer cachexia patients, with impressive weight gain and activity improvements versus placebo.
The interim Phase 2 CAReS data for ART27.13 represents a potentially significant advancement in treating cancer anorexia-cachexia syndrome (CACS), a condition with limited effective treatments. The +6% average weight gain in patients receiving the highest dose compared to a ~5% weight loss in the placebo group over 12 weeks is clinically meaningful, as weight stabilization alone would be considered beneficial in this patient population.
What's particularly promising is the improvement in lean body mass alongside total weight gain. In cachexia, patients typically lose metabolically active muscle tissue, not just fat, leading to weakness, reduced mobility, and poorer clinical outcomes. The preservation or accrual of muscle tissue suggested by these results addresses a core pathophysiological mechanism of CACS.
The wearable data demonstrating increased activity is especially noteworthy. Functional status improvements correlate with quality of life and often predict better clinical outcomes, suggesting ART27.13 may provide benefits beyond simple weight maintenance. This multidimensional improvement pattern (weight, muscle mass, and activity) strengthens the clinical relevance of these findings.
The safety profile appears favorable with mostly mild to moderate adverse events and no serious drug-related events reported. This is critical for a cachexia treatment, as these patients are already compromised by their underlying cancer and often receiving multiple medications.
While these are interim results from a Phase 2 study, the consistent improvements across multiple metrics and dose-dependent response pattern (with best outcomes at highest doses) enhance the biological plausibility of the findings and suggest a real treatment effect rather than statistical noise. As a lipid-signaling pathway modulator, ART27.13's mechanism aligns with emerging understanding of cachexia's complex pathophysiology, potentially addressing both appetite and metabolic dysregulation components of the syndrome.
Patients treated with ART27.13 showed consistent improvements in weight, lean body mass, and activity
While clinical benefits were observed in all treated cohorts, the best outcomes in CAReS were observed in patients titrated to the highest dose
SOLANA BEACH, Calif., Sept. 29, 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, dermatologic, or neurological conditions, today announced the first public presentation of the interim data from its Phase 2 Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 in patients with cancer anorexia-cachexia syndrome (CACS). The data were presented by Barry Laird, Professor of Palliative Medicine, Oslo University Hospital - Radium Hospital and University of Oslo, Norway, and Chief Investigator in CAReS, at the 8th Cancer Cachexia Society (CCS) Conference held September 25–27, 2025 in Turin, Italy.
The CCS presentation showed the actual interim data underlying previously announced summary results of ART27.13’s potential to meaningfully impact weight gain, lean body mass, and daily activity in patients with CACS. Importantly, Professor Laird’s presentation introduced new insights from digital wearable data, which showed that patients treated with ART27.13 had greater frequency and intensity in daily activity compared to placebo, reinforcing the therapy’s potential to improve both physical outcomes and quality of life in cancer patients suffering from this debilitating condition.
Interim Data Highlights
- Weight Gain: Patients who had lost at least
5% of body weight to be included in CAReS and titrated to the highest ART27.13 dose (1300 µg) achieved an average +6% weight gain over 12 weeks, while patients on placebo lost an additional ~5% . - Lean Body Mass: Improvements in lean body mass were aligned with total weight gains, suggesting preservation or accrual of muscle, consistent with pre-clinical research with ART27.13.
- Activity: Digital wearable data confirmed greater daily activity metrics among treated patients compared to placebo.
- Safety: ART27.13 continued to exhibit a favorable safety profile, with adverse events mostly mild to moderate and no serious drug-related events reported.
Steven D. Reich, MD, Chief Medical Officer at Artelo commented, “These interim findings provide strong evidence that ART27.13 can help address the profound weight and activity loss experienced by patients with cancer anorexia-cachexia syndrome. With ART27.13 we are seeing consistent improvements not just in weight, but also in lean body mass and activity—outcomes that are highly meaningful to patients’ daily lives.”
In addition to CCS participants hearing Professor Laird’s presentation, Artelo’s Senior Vice President and Chief Scientific Officer, Andy Yates, PhD, attended CCS 2025 to engage with global thought leaders and advance partnering discussions with pharmaceutical companies that have expressed interest in ART27.13. These efforts are aligned with the Company’s strategy to maximize the therapeutic and commercial potential of its lead program.
“Discussing the interim CAReS results at CCS 2025 allowed us to engage with the global research community, foster collaboration, and advance partnering discussions for a much-needed therapy in this area of critical unmet need,” added Dr. Yates.
Data from Professor Laird’s presentation have been added to Artelo’s corporate presentation available on the Company’s website here.
About ART27.13
ART27.13 is a novel benzimidazole derivative and dual cannabinoid agonist being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca plc, ART27.13 has been in seven clinical studies with over 280 participants. A statistically significant and dose-dependent increase in body weight was observed in people with back pain who were otherwise healthy. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Having completed the Phase 1 portion of the CAReS study in cancer patients where ART27.13 demonstrated an excellent safety profile, Artelo is conducting the Phase 2 portion of the trial as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome.
About CAReS
The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in patients with cancer anorexia and weight loss. Cancer-related anorexia, or the lack or loss of appetite in the person with cancer, may result from the cancer and/or its treatment with radiation or chemotherapy. It is common for people with cancer to lose weight. Anorexia and the resulting weight loss can affect a patient’s health, often weakening their immune system and causing discomfort and dehydration. A weight loss of more than
(ISRCTN registry: https://www.isrctn.com/ISRCTN15607817)
About CACS
Cancer Anorexia-Cachexia Syndrome (CACS) is a condition marked by loss of appetite, weight loss, and the breakdown of muscle and fat, affecting up to
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, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by an experienced executive team collaborating with world-class researchers and digital-asset technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices, including digital assets, to maximize stakeholder value. More information is available at www.artelobio.com and X: @ArteloBio.
Forward Looking Statements
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Investor Relations Contact:
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FAQ
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