Artelo Biosciences Announces Presentation of Phase 1 Data with ART27.13 in Cancer-Related Anorexia
Artelo Biosciences (ARTL) presented Phase 1 data from the CAReS trial for ART27.13, their investigational drug for cancer-related anorexia. The trial demonstrated promising results with two-thirds of participants showing stabilized or reversed weight loss after one month of treatment. The drug was well-tolerated with only mild to moderate adverse events in a minority of participants, with no serious adverse events recorded.
The Phase 2 portion of the trial is currently enrolling participants across fifteen sites in five countries, administering 650 microgram doses with planned escalation up to 1300 micrograms daily. The study will evaluate endpoints including lean body mass, weight gain, quality of life, and safety, with completion expected in the first half of 2025.
Artelo Biosciences (ARTL) ha presentato dati della Fase 1 dello studio CAReS per ART27.13, il loro farmaco in fase di sperimentazione per l'anoressia legata al cancro. Lo studio ha mostrato risultati promettenti, con due terzi dei partecipanti che hanno mostrato una stabilizzazione o una inversione della perdita di peso dopo un mese di trattamento. Il farmaco è stato ben tollerato, con solo eventi avversi da lievi a moderati in una minoranza di partecipanti, senza eventi avversi gravi registrati.
La fase 2 dello studio sta attualmente reclutando partecipanti in quindici centri in cinque paesi, somministrando dosi da 650 microgrammi con un'eventuale escalation fino a 1300 microgrammi al giorno. Lo studio valuterà parametri come la massa corporea magra, l'aumento di peso, la qualità della vita e la sicurezza, con completamento previsto per la prima metà del 2025.
Artelo Biosciences (ARTL) presentó datos de la Fase 1 del ensayo CAReS para ART27.13, su medicamento en investigación para la anorexia relacionada con el cáncer. El ensayo mostró resultados prometedores, con dos tercios de los participantes mostrando estabilización o reversión de la pérdida de peso después de un mes de tratamiento. El medicamento fue bien tolerado, con solo eventos adversos leves a moderados en una minoría de los participantes, y sin eventos adversos graves registrados.
La Fase 2 del ensayo se encuentra actualmente reclutando participantes en quince sitios en cinco países, administrando dosis de 650 microgramos con una escalada planificada de hasta 1300 microgramos diarios. El estudio evaluará puntos finales que incluyen masa corporal magra, aumento de peso, calidad de vida y seguridad, con finalización esperada en la primera mitad de 2025.
Artelo Biosciences (ARTL)는 암 관련 식욕 부진 치료제인 ART27.13의 CAReS 시험에서 1상 데이터를 발표했습니다. 이 시험은 참여자의 3분의 2가 1개월 치료 후 체중 감소의 안정화 또는 개선을 보였음을 보여주는 유망한 결과를 나타냈습니다. 이 약물은 소수의 참가자에서 경미한 부작용만 있어 잘 견뎌졌으며, 심각한 부작용은 기록되지 않았습니다.
시험의 2상 단계는 현재 5개 나라의 15개 사이트에서 참가자를 모집하고 있으며, 650 마이크로그램의 용량을 투여하고 있으며 최대 1300 마이크로그램까지 점진적으로 증가할 예정입니다. 이 연구는 체지방량, 체중 증가, 삶의 질, 안전성 등의 평가지표를 평가할 것이며, 2025년 상반기 중 완료될 예정입니다.
Artelo Biosciences (ARTL) a présenté des données de Phase 1 de l'essai CAReS pour ART27.13, leur médicament expérimental pour l'anorexie liée au cancer. L'essai a montré des résultats prometteurs, avec deux tiers des participants montrant une stabilisation ou une inversion de la perte de poids après un mois de traitement. Le médicament a été bien toléré, avec seulement des événements indésirables légers à modérés chez une minorité des participants, sans événements indésirables graves enregistrés.
La phase 2 de l'essai recrute actuellement des participants dans quinze sites répartis sur cinq pays, administrant des doses de 650 microgrammes avec une escalade prévue jusqu'à 1300 microgrammes par jour. L'étude évaluera des critères tels que la masse corporelle maigre, la prise de poids, la qualité de vie et la sécurité, avec une conclusion attendue dans la première moitié de 2025.
Artelo Biosciences (ARTL) hat Phase-1-Daten aus der CAReS-Studie für ART27.13 vorgestellt, ihr experimentelles Medikament zur Behandlung der krebsbedingten Anorexie. Die Studie zeigte vielversprechende Ergebnisse, wobei zwei Drittel der Teilnehmer eine Stabilisierung oder Umkehrung des Gewichtsverlusts zeigten nach einem Monat Behandlung. Das Medikament wurde gut vertragen, mit nur milden bis moderaten Nebenwirkungen bei einer Minderheit der Teilnehmer, ohne schwere Nebenwirkungen.
Die Phase-2-Studie rekrutiert derzeit Teilnehmer an fünfzehn Standorten in fünf Ländern und verabreicht Dosen von 650 Mikrogramm mit einer geplanten Erhöhung auf bis zu 1300 Mikrogramm täglich. Die Studie wird Endpunkte wie fettfreie Körpermasse, Gewichtszunahme, Lebensqualität und Sicherheit bewerten, wobei der Abschluss für die erste Hälfte des Jahres 2025 erwartet wird.
- Two-thirds of participants showed stabilization or reversal of weight loss
- Drug demonstrated good safety profile with only mild to moderate adverse events
- Phase 2 trial actively enrolling across 15 sites in 5 countries
- No serious or life-threatening adverse events recorded in Phase 1
- Study completion not expected until first half of 2025
- No currently approved therapies in target markets (UK, US, Europe)
Insights
The Phase 1 data from the CAReS trial demonstrates compelling preliminary efficacy and safety for ART27.13 in treating cancer-related anorexia. The key findings show that two-thirds of participants experienced stabilization or reversal of weight loss after one month of treatment, with only mild to moderate adverse events reported. This is particularly significant given the current lack of approved therapies for this condition in major markets.
The progression to Phase 2 with a higher dosing regimen (up to 1300 micrograms from 650 micrograms) and the inclusion of objective measurements like wearable activity monitors strengthens the study design. The focus on multiple endpoints including lean body mass, weight gain and quality of life provides a comprehensive evaluation of the drug's potential therapeutic benefits. The expected completion of enrollment in H1 2025 positions this as a near-term catalyst for ARTL.
For a micro-cap company with a market cap of just
The addition of objective endpoints through wearable technology could provide valuable data to support future commercialization efforts. With no approved therapies in major markets, ART27.13 could capture significant market share if successfully developed. However, investors should note that additional capital may be needed to complete the Phase 2 study and advance the program.
Phase 1 data from the CAReS trial showed an attractive safety profile and promising activity from daily ART27.13 administration with two-thirds of participants having stabilized or reversed weight loss at one month of treatment
SOLANA BEACH, Calif., Dec. 09, 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, today announced the presentation of preliminary data on ART27.13, the Company’s benzimidazole derivative, being studied for cancer-related anorexia. The data was presented by the Principal Investigator, Professor Barry J. A. Laird, Chair of Palliative and Supportive Care, University of Edinburgh and Consultant Physician in Palliative Medicine, Edinburgh Cancer Centre, at the 17th International Conference on Sarcopenia, Cachexia, & Wasting Disorders, held December 6-8, 2024 in Washington D.C.
Artelo is evaluating ART27.13 in the Cancer Appetite Recovery Study (CAReS), a randomized, placebo-controlled Phase 1/2 trial in cancer-related anorexia, which is currently enrolling the Phase 2 of the study. In the Phase 1 of CAReS, ART27.13 was orally administered at 150 to 650 microgram doses in multiple centers throughout the UK and Ireland. The investigational drug was well tolerated with only mild to moderate adverse events observed in a minority of participants. No serious or life-threatening adverse events were recorded. Importantly, at one month of treatment, two-thirds of participants showed evidence the drug was impacting their weight loss with either stabilization or reversal of weight loss associated with their cancer.
“With no therapies approved to treat cancer-related anorexia in the UK, US, or Europe, I am impressed by the effect of ART27.13 at low doses in the majority of the participants in CAReS,” commented Prof. Laird of the University of Edinburgh. “The results are particularly encouraging in these advanced cancer patients where the highest dose evaluated in the initial study was found to be well tolerated and was advanced for further evaluation as the starting dose in Phase 2.”
Open to enrollment in fifteen sites across five countries, the Phase 2 of CAReS is accruing participants at a 650 microgram dosage with planned escalation at 4-week intervals up to a dose of 1300 micrograms per day. In CAReS, all participants receive ART27.13 once-daily for up to 12 weeks and the endpoints include lean body mass, weight gain, quality of life and safety. The Phase 2 portion will also evaluate any impact on activity levels using a monitor attached to the patient’s wrist. The study is expected to complete enrollment during the first half of 2025.
Steven D. Reich, MD, Chief Medical Officer of Artelo Biosciences, added, “ART27.13 has the potential to become a major drug for the treatment of loss of appetite and weight in patients with cancer. As previously reported, preclinical research with ART27.13 showed the drug was protective against myotube degeneration in cancer cachexia conditions. The addition of a wearable monitor may show improved activity believed to be attributable to protection against muscle loss. We look forward to evaluating the results of the full study next year.”
About ART27.13
ART27.13 is a benzimidazole derivative being developed as a once-a-day, orally administered drug to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. This new chemical entity is a highly potent, peripherally restricted, CB1 and CB2 receptor agonists. Originally developed by AstraZeneca plc, ART27.13 has been in clinical studies with over 250 participants. A statistically significant and dose-dependent increase in body weight was observed in patients 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 attractive safety profile, ART27.13 is now being investigated in a placebo-controlled phase 2 in cancer patients suffering from anorexia and weight loss. Currently, there is no FDA- or EMA-approved treatment for cancer anorexia cachexia syndrome.
About CAReS
The Cancer Appetite Recovery Study (CAReS) (carestrial.com) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s 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 five percent can predict a poor outcome for cancer patients and a lower response to chemotherapy. Now completed, the Phase 1 portion of the CAReS study was designed to determine a safe starting dose of ART27.13 for dosing in the Phase 2 portion of the study. Currently enrolling, the Phase 2 portion of the CAReS study is designed to determine estimates of activity of ART27.13 versus placebo in terms of lean body mass, weight gain, and improvement of anorexia and activity. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817)
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.
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, 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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