Artelo Biosciences Receives Notice of Allowance from European Patent Office for the Patent Claims for the Intended Commercial Formulation of ART27.13
Artelo Biosciences (Nasdaq: ARTL) has received a Notice of Allowance from the European Patent Office for patent application No. 21827629.3, covering the intended commercial formulation of ART27.13, their peripherally selective cannabinoid agonist. The patent protection extends through December 2041 and covers compositions of ART27.13 dispersed in polyethylene glycol.
The drug is currently in Phase 2 clinical trials (CAReS study) for cancer-related anorexia, which affects over 60% of advanced-stage cancer patients. In Phase 1, ART27.13 demonstrated positive results, with more than 60% of participants showing stabilized or reversed weight loss. Initial Phase 2 results are expected in Q3 2025.
Artelo Biosciences (Nasdaq: ARTL) ha ricevuto una Notifica di Concessione dall'Ufficio Europeo dei Brevetti per la domanda di brevetto n. 21827629.3, relativa alla formulazione commerciale prevista di ART27.13, il loro agonista cannabinoide a selettività periferica. La protezione brevettuale copre fino a dicembre 2041 e riguarda composizioni di ART27.13 disperse in polietilenglicole.
Il farmaco è attualmente in studi clinici di fase 2 (studio CAReS) per l'anoressia correlata al cancro, condizione che interessa oltre il 60% dei pazienti in stadio avanzato. Nella fase 1 ART27.13 ha mostrato risultati positivi, con più del 60% dei partecipanti che ha stabilizzato o invertito la perdita di peso. I primi risultati della fase 2 sono attesi nel terzo trimestre 2025.
Artelo Biosciences (Nasdaq: ARTL) ha recibido una Notificación de concesión de la Oficina Europea de Patentes para la solicitud de patente n.º 21827629.3, que cubre la formulación comercial prevista de ART27.13, su agonista cannabinoide con selectividad periférica. La protección por patente se extiende hasta diciembre de 2041 e incluye composiciones de ART27.13 dispersas en polietilenglicol.
El fármaco se encuentra actualmente en ensayos clínicos de fase 2 (estudio CAReS) para la anorexia relacionada con el cáncer, que afecta a más del 60% de los pacientes en estadios avanzados. En la fase 1, ART27.13 mostró resultados positivos, con más del 60% de los participantes que estabilizaron o revirtieron la pérdida de peso. Se esperan los primeros resultados de la fase 2 en el tercer trimestre de 2025.
Artelo Biosciences (Nasdaq: ARTL)는 유럽특허청으로부터 특허출원 번호 21827629.3에 대한 허가 통지(Notice of Allowance)를 받았습니다. 해당 출원은 주변 선택적 카나비노이드 작용제인 ART27.13의 상업용 제형을 대상으로 합니다. 특허 보호는 2041년 12월까지 유효하며, 폴리에틸렌글리콜에 분산된 ART27.13 조성물을 포함합니다.
이 약물은 현재 암 관련 식욕부진을 대상으로 한 2상 임상시험(CAReS 연구)을 진행 중이며, 이는 진행성 암 환자의 60% 이상에게 영향을 줍니다. 1상에서 ART27.13은 긍정적인 결과를 보였으며, 참가자의 60% 이상에서 체중 감소가 안정되거나 회복되었습니다. 2상 초기 결과는 2025년 3분기에 예상됩니다.
Artelo Biosciences (Nasdaq: ARTL) a reçu un avis d'acceptation de l'Office européen des brevets pour la demande de brevet n° 21827629.3, couvrant la formulation commerciale prévue de ART27.13, leur agoniste cannabinoïde à sélectivité périphérique. La protection par brevet s'étend jusqu'en décembre 2041 et porte sur des compositions d'ART27.13 dispersées dans du polyéthylène glycol.
Le médicament est actuellement en essais cliniques de phase 2 (étude CAReS) pour l'anorexie liée au cancer, qui touche plus de 60 % des patients en phase avancée. En phase 1, ART27.13 a montré des résultats positifs, plus de 60 % des participants ayant stabilisé ou inversé la perte de poids. Les premiers résultats de la phase 2 sont attendus au 3e trimestre 2025.
Artelo Biosciences (Nasdaq: ARTL) hat vom Europäischen Patentamt eine Notice of Allowance für die Patentanmeldung Nr. 21827629.3 erhalten, die die vorgesehene kommerzielle Formulierung von ART27.13, ihrem peripher selektiven Cannabinoid-Agonisten, abdeckt. Der Patentschutz gilt bis Dezember 2041 und umfasst Zusammensetzungen von ART27.13, die in Polyethylenglykol dispergiert sind.
Das Arzneimittel befindet sich derzeit in Phase-2-Studien (CAReS-Studie) zur krebsbedingten Appetitlosigkeit, die mehr als 60 % der Patienten im fortgeschrittenen Stadium betrifft. In Phase 1 zeigte ART27.13 positive Ergebnisse, wobei mehr als 60 % der Teilnehmer den Gewichtsverlust stabilisieren oder umkehren konnten. Erste Ergebnisse der Phase 2 werden für das 3. Quartal 2025 erwartet.
- Patent protection secured through December 2041 for commercial formulation
- Phase 1 trial showed positive results with 60% of participants showing weight stabilization or reversal
- Addresses large market with no currently approved therapies in US, UK, or EU
- Initial Phase 2 results expected in Q3 2025
- Drug still in early clinical stages with no guarantee of regulatory approval
- Commercial launch timeline remains uncertain pending clinical trial results
Insights
Artelo secures crucial European patent protection for ART27.13's commercial formulation through 2041, significantly enhancing its market exclusivity potential.
This patent allowance represents a significant milestone in Artelo's intellectual property strategy. The allowed claims specifically protect compositions of ART27.13 dispersed in polyethylene glycol, which is the company's intended commercial formulation. Patent protection extending through December 2041 provides Artelo with nearly 16 years of potential market exclusivity in Europe, assuming the drug receives regulatory approval.
The timing is particularly strategic as ART27.13 progresses through clinical development. The drug is currently in a Phase 2 study for cancer-related anorexia, with initial results expected in Q3 2025. The Phase 1 data showed promising safety profiles and early efficacy signals, with weight stabilization or reversal in over 60% of participants.
From a commercial perspective, this patent allowance significantly enhances ART27.13's market potential. Cancer-related anorexia affects over 60% of advanced cancer patients, yet there are currently no approved therapies in major markets including the US, UK, and EU. This represents a substantial unmet medical need and market opportunity.
For investors, this development reduces one key risk factor in Artelo's development pipeline - intellectual property protection for their lead asset in a major market. Combined with the unmet medical need and the drug's progress through clinical stages, this patent allowance positions Artelo more favorably for potential partnerships, licensing deals, or even acquisition interest from larger pharmaceutical companies seeking to expand their oncology supportive care portfolios.
Artelo's ART27.13 shows promising early clinical results for cancer-related anorexia, addressing a significant unmet need affecting majority of advanced cancer patients.
Cancer-related anorexia is a severely undertreated condition that dramatically impacts patient quality of life and treatment outcomes. It affects over 60% of patients with advanced cancer and contributes to the development of cachexia, a wasting syndrome characterized by weight loss, muscle atrophy, and metabolic abnormalities. Currently, there are no approved treatments specifically for this condition in major markets.
ART27.13's mechanism as a peripherally selective cannabinoid agonist is particularly noteworthy. By targeting peripheral CB1/CB2 receptors while minimizing central nervous system penetration, this approach potentially offers the appetite-stimulating benefits of cannabinoids without the psychoactive effects that limit the utility of other cannabis-derived therapies.
The preliminary clinical data from the Phase 1 portion of the CAReS trial is encouraging. The drug was well-tolerated and showed early efficacy signals with more than 60% of participants experiencing stabilized or reversed weight loss. These early signals suggest potential clinical benefit, though the upcoming Phase 2 results will be crucial for validating these findings in a larger patient population.
From a clinical development perspective, having secured patent protection for the commercial formulation removes a significant hurdle on the path to potential market approval. The polyethylene glycol formulation is likely critical for proper drug delivery and bioavailability, and protecting this specific composition ensures that if efficacy is demonstrated in the ongoing Phase 2 study, Artelo has a clear path to commercialization with exclusive rights.
Extends Patent Protection Through December 2041
ART27.13 is Currently under Evaluation in a Phase 2 Study for the Treatment of Cancer-Related Anorexia
SOLANA BEACH, Calif., Aug. 11, 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 that the European Patent Office (EPO) has issued a Notice of Allowance for Artelo’s European patent application No. 21827629.3. The application covers the intended commercial formulation of ART27.13, the Company’s peripherally selective cannabinoid agonist currently under evaluation in the Phase 2 CAReS trial for the treatment of cancer-related anorexia.
The allowed claims protect compositions of ART27.13 dispersed in polyethylene glycol, including the Company’s intended commercial formulation. This development marks a major milestone in Artelo’s global intellectual property strategy and positions the Company for long-term value creation.
“Securing this Notice of Allowance from the EPO is an important step in protecting the commercial potential of ART27.13,” said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “Cancer-related anorexia affects over
ART27.13 is being evaluated in the CAReS clinical trial, a Phase 1/2 study targeting cancer-related anorexia. The investigational drug was well tolerated in the Phase 1 stage and showed early signs of stabilizing or reversing weight loss in more than
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 six clinical studies with over 250 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 now advancing it in the Phase 2 CAReS 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
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 a newly authorized digital asset treasury strategy. As the first publicly traded pharmaceutical company to designate Solana as a core reserve asset, Artelo intends to leverage Solana’s high-performance, decentralized blockchain to diversify its balance sheet, enhance liquidity management, and position the Company for long-term value creation in parallel with its therapeutic programs. Guided by disciplined risk controls and staged investments approved by the Board of Directors, this Solana-centric strategy is designed to preserve working capital for the continued advancement and commercialization of Artelo’s product candidates while affording shareholders exposure to a next-generation monetary network. 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, among other things, the potential of ART27.13 to be a first-in-class treatment for cancer-related anorexia, the value of ART27.13, the anticipated benefits of the Company’s intellectual property strategy, the anticipated timing of releasing initial results from the Phase 2 portion of the CAReS study, and 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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