Artelo Biosciences Announces Positive Interim Phase 2 CAReS Results for the Treatment of Cancer Anorexia-Cachexia Syndrome (CACS)
Artelo Biosciences (Nasdaq: ARTL) announced encouraging interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS) trial for ART27.13, a treatment for cancer anorexia-cachexia syndrome (CACS). The study showed significant positive outcomes, with patients receiving the 1300 microgram dose achieving a +6.38% mean weight gain after 12 weeks, compared to -5.42% loss in placebo group.
Key highlights include a +4.23% increase in lean body mass at one month for treated patients, while placebo patients lost -3.15%. The drug demonstrated a favorable safety profile with mostly mild to moderate adverse events. The positive results are accelerating Artelo's partnering discussions with pharmaceutical companies for ART27.13, which targets CACS, a condition affecting up to 80% of cancer patients with no current FDA-approved treatment.
Artelo Biosciences (Nasdaq: ARTL) ha reso noti risultati intermedi incoraggianti dallo studio di Fase 2 CAReS (Cancer Appetite Recovery Study) sul ART27.13, terapia per la sindrome anoressia-cachessia da cancro (CACS). Lo studio ha mostrato esiti significativamente favorevoli: i pazienti trattati con la dose da 1300 microgrammi hanno registrato un guadagno medio di peso del +6,38% dopo 12 settimane, rispetto a una perdita del -5,42% nel gruppo placebo.
Punti salienti includono un aumento del 4,23% della massa corporea magra dopo un mese nei pazienti trattati, mentre quelli in placebo hanno perso il -3,15%. Il farmaco ha evidenziato un profilo di sicurezza favorevole, con eventi avversi per lo più lievi o moderati. Questi risultati positivi stanno accelerando le trattative di Artelo con aziende farmaceutiche per la partnership su ART27.13, destinata a trattare la CACS, condizione che colpisce fino al 80% dei pazienti oncologici e per la quale non esistono terapie approvate dalla FDA.
Artelo Biosciences (Nasdaq: ARTL) anunció resultados interinos alentadores del ensayo de Fase 2 CAReS (Cancer Appetite Recovery Study) con ART27.13, un tratamiento para el síndrome de anorexia-caquexia en cáncer (CACS). El estudio mostró resultados significativamente positivos: los pacientes que recibieron la dosis de 1300 microgramos lograron un incremento medio de peso del +6,38% tras 12 semanas, frente a una pérdida del -5,42% en el grupo placebo.
Entre los puntos clave destaca un aumento del 4,23% en la masa corporal magra al mes en pacientes tratados, mientras que los del placebo perdieron -3,15%. El fármaco presentó un perfil de seguridad favorable, con eventos adversos mayoritariamente leves a moderados. Estos resultados positivos están acelerando las conversaciones de Artelo con compañías farmacéuticas para asociarse en ART27.13, dirigido a la CACS, una condición que afecta hasta al 80% de los pacientes con cáncer y para la cual no existe tratamiento aprobado por la FDA.
Artelo Biosciences (Nasdaq: ARTL)는 ART27.13에 대한 2상 CAReS(Cancer Appetite Recovery Study) 중간 결과가 고무적이라고 발표했습니다. 이 약물은 암 관련 식욕부진-카헥시아 증후군(CACS) 치료제입니다. 연구 결과에 따르면 1300마이크로그램 투여군은 12주 후 평균 체중 +6.38% 증가를 보였고, 위약군은 -5.42% 체중 감소를 기록했습니다.
주요 성과로는 치료군이 1개월 시점에서 제지방량 4.23% 증가를 보인 반면, 위약군은 -3.15% 감소한 점이 있습니다. 약물은 대부분 경증~중등도의 이상반응을 보이며 안전성 프로파일이 양호했습니다. 이러한 긍정적 결과는 ART27.13의 제약사 파트너십 논의를 가속화하고 있으며, CACS는 전체 암 환자의 최대 80%에 영향을 미치고 현재 FDA 승인 치료제가 없습니다.
Artelo Biosciences (Nasdaq: ARTL) a annoncé des résultats intermédiaires encourageants de son essai de phase 2 CAReS (Cancer Appetite Recovery Study) pour ART27.13, un traitement du syndrome anorexie‑cachexie lié au cancer (CACS). L'étude a révélé des résultats significatifs : les patients recevant la dose de 1300 microgrammes ont enregistré une prise de poids moyenne de +6,38% après 12 semaines, contre une perte de -5,42% dans le groupe placebo.
Parmi les points marquants, on note une augmentation de la masse maigre de +4,23% au bout d'un mois chez les patients traités, tandis que les patients sous placebo ont perdu -3,15%. Le médicament a présenté un profil de sécurité favorable, avec des effets indésirables principalement légers à modérés. Ces résultats positifs accélèrent les discussions de partenariat d'Artelo avec des laboratoires pharmaceutiques pour ART27.13, ciblant la CACS, une affection touchant jusqu'à 80% des patients atteints de cancer et sans traitement approuvé par la FDA à ce jour.
Artelo Biosciences (Nasdaq: ARTL) meldete ermutigende Zwischenergebnisse aus der Phase‑2‑Studie CAReS (Cancer Appetite Recovery Study) zu ART27.13, einer Behandlung des cancerbedingten Anorexie‑Kachexie‑Syndroms (CACS). Die Studie zeigte signifikant positive Resultate: Patienten, die die 1300‑Mikrogramm‑Dosis erhielten, erzielten nach 12 Wochen einen durchschnittlichen Gewichtszuwachs von +6,38%, gegenüber einem Verlust von -5,42% in der Placebo‑Gruppe.
Wesentliche Ergebnisse sind unter anderem ein +4,23% Anstieg der fettfreien Körpermasse nach einem Monat bei den Behandelten, während Placebo‑Patienten -3,15% verloren. Das Medikament wies ein günstiges Sicherheitsprofil mit überwiegend leichten bis mäßigen Nebenwirkungen auf. Die positiven Daten beschleunigen Artelos Partnersuche mit Pharmaunternehmen für ART27.13, das auf CACS abzielt — eine Erkrankung, die bis zu 80% der Krebspatienten betrifft und derzeit keine von der FDA zugelassene Therapie hat.
- Significant +6.38% mean weight gain in treated patients vs -5.42% loss in placebo group
- Notable +4.23% increase in lean body mass vs -3.15% loss in placebo group
- Favorable safety profile with mostly mild to moderate adverse events
- Patent allowance covering commercial formulation through 2041
- Treatment addresses unmet need with no FDA-approved alternatives for CACS
- Only 18 evaluable patients in interim analysis, indicating small sample size
- 22% of participants experienced adverse events potentially related to treatment
Insights
Artelo's ART27.13 shows remarkable efficacy for cancer cachexia with 6.4% weight gain vs placebo's 5.4% loss, advancing partnership opportunities.
Artelo's interim Phase 2 results for ART27.13 represent a potential breakthrough in cancer anorexia-cachexia syndrome (CACS), a condition affecting up to 80% of cancer patients with no FDA-approved treatments. The data is particularly impressive considering CACS's grave impact as a leading cause of cancer mortality.
The efficacy data is compelling: patients receiving the 1300 microgram dose achieved a +6.38% mean weight gain after 12 weeks, while placebo patients experienced a -5.42% weight loss. This nearly 12% difference between treatment and control is clinically meaningful in this patient population. Even more striking is the maximum weight gain of +18.5% in the treatment arm versus just +0.4% in placebo.
Beyond weight, the +4.23% increase in lean body mass (versus -3.15% for placebo) is particularly significant, as preserving muscle mass is crucial for maintaining functional status and quality of life in cancer patients. The improvements in activity scores and vigorous activity further support the clinical benefit, as reduced physical function is a hallmark of cachexia progression.
The safety profile appears favorable, with most adverse events being mild or moderate, consistent with Phase 1 findings. This safety-efficacy balance is essential for a population already burdened by cancer treatments.
While these results are from a relatively small interim analysis (18 evaluable patients), the magnitude of effect and consistency across multiple endpoints suggest a genuine therapeutic benefit rather than statistical noise. The company's plan to potentially start patients directly at the highest dose in future studies makes clinical sense based on the observed dose-response relationship.
The development of an effective CACS treatment would address a significant unmet medical need and could become standard of care for hundreds of thousands of cancer patients globally, particularly those with advanced disease where maintaining function and quality of life are primary goals.
The interim Phase 2 CAReS results for ART27.13 represent a significant value inflection point for Artelo Biosciences. Cancer anorexia-cachexia syndrome affects approximately 1 million patients annually in North America and Europe alone, creating a substantial market opportunity with no FDA-approved treatments.
The efficacy data showing +6.38% weight gain for treated patients versus -5.42% loss for placebo is compelling for three key reasons: First, the magnitude of difference (~12%) exceeds what would typically be considered clinically meaningful; second, the improvements span multiple relevant parameters (weight, lean mass, activity); and third, these effects occurred with an acceptable safety profile in a vulnerable patient population.
Strategically, Artelo's pivot to accelerate partnership discussions is prudent given their market capitalization and the resources required for Phase 3 trials. The recently announced patent protection through 2041 significantly strengthens their negotiating position with potential pharmaceutical partners who were awaiting randomized data.
The cannabinoid receptor agonist mechanism of ART27.13 offers a differentiated approach to cachexia compared to competing development programs, many of which target ghrelin or inflammatory pathways. The peripherally-acting nature of the compound may explain the favorable safety profile with limited CNS side effects typically associated with cannabinoids.
While the sample size of this interim analysis is modest (18 evaluable patients), the clear dose-response relationship and consistent effects across multiple parameters increase confidence in the results. The plan to potentially start patients at the highest dose in future studies could accelerate development timelines and improve overall efficacy outcomes.
This data positions Artelo to potentially secure a development partnership with upfront payments and milestone-based economics, which would significantly extend their cash runway and reduce development risk. For a small biotech, these results represent the exact type of clinical validation needed to attract pharmaceutical partnership interest in their lead asset.
Catalyst for Advancing Discussions with Pharmaceutical Companies that have Expressed Interest in ART27.13 for CACS
Consistent Improvements in Weight Gain, Lean Body Mass, and Activity were Observed Across Treated Patients including +
Safety Results Showed ART27.13 was Well Tolerated
SOLANA BEACH, Calif., Sept. 03, 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 highly encouraging interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS) trial with ART27.13, the Company’s peripherally acting cannabinoid receptor agonist for the treatment of cancer anorexia-cachexia syndrome (CACS). Affecting up to
Highlights:
- Weight Gain: Patients escalated to the 1300 microgram dose achieved a +
6.38% mean weight gain after 12 weeks, compared to a -5.42% average loss on placebo. The maximum gain observed was +18.5% on ART27.13 versus only +0.4% on placebo. - Lean Body Mass: At one month, patients treated with ART27.13 experienced a +
4.23% increase in lean body mass, while placebo patients lost -3.15% . - Activity: Patients receiving treatment showed improvements in activity scores and in moderate and vigorous activity, the latter being an endpoint that may be required by regulators for drug approval.
- Safety: ART27.13 was well tolerated. The most common adverse events were mild or moderate. No new safety signals were observed and interim safety results were consistent with Phase 1 of CAReS.
Barry Laird, Professor of Palliative Medicine, Oslo University Hospital - Radium Hospital and University of Oslo, Norway, and Chief Investigator in CAReS said, "The findings from the CAReS Phase 2 interim analysis build on the strong safety profile and signal from the Phase 1 trial and provide encouraging data supporting efficacy of ART27.13 on weight and physical activity in patients with advanced cancer.”
The Phase 2 CAReS study is evaluating ART27.13 as a once-daily oral treatment aimed at improving weight, appetite, activity, and quality of life in cancer patients who had lost a minimum of
In the interim analysis, 18 evaluable patients—primarily with lung and gastrointestinal cancers not receiving cyclic chemotherapy—were included. After 12 weeks of treatment in patients who titrated to the top dose evaluated of 1300 micrograms (n=5), ART27.13 demonstrated compelling increases in mean body weight of
Safety results were consistent with prior findings. Among the 32 participants enrolled in the CAReS Phase 2 trial to date, 7 patients (
“These data represent a reassuring and convincing drug effect for the highest dose of ART27.13 tested,” stated Steven Reich, MD, Chief Medical Officer of Artelo. “For patients facing the devastating effects of cancer anorexia and cachexia, we believe these findings are particularly promising, especially for the Phase 2 protocol patients that had intra-patient dose-escalation. With these interim results, we are evaluating plans to advance the ART27.13 program by starting patients at the highest dose, which has the greatest treatment effect and acceptable safety.”
Gregory D. Gorgas, President and CEO of Artelo, commented, “Based on the strength of this data and the recently announced Notice of Allowance for the patent application covering our intended commercial formulation through 2041, we are rapidly accelerating our licensing strategy as the most value-accretive path forward. We are in the process of sharing these results with global and regional pharmaceutical companies already familiar with ART27.13 who were awaiting this randomized data from the CAReS trial. Through this targeted effort we aim to speed development and maximize value for our shareholders.”
About ART27.13
ART27.13 is a novel benzimidazole derivative 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 a Phase 1 study in cancer patients where ART27.13 demonstrated an excellent safety profile, Artelo is conducting a Phase 2 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. Complementing its scientific innovation, Artelo has adopted a forward-looking corporate finance initiative whereby it is deploying a portion of its excess capital into Solana under its digital asset treasury strategy. 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 to maximize stakeholder value. More information is available at www.artelobio.com and X: @ArteloBio.
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 product development, including future plans in respect to ART27.13, potential transactions with pharmaceutical companies or other strategic counterparties in respect of ART27.13, 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
Email: ARTL@crescendo-ir.com
FAQ
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