Artelo Biosciences Receives U.S. Patent Notice of Allowance for ART27.13 Commercial Formulation
核心洞察
Artelo Biosciences (搜索) received a Notice of Allowance from the U.S. Patent and Trademark Office covering the intended commercial formulation of ART27.13, its peripherally selective cannabinoid agonist.
The allowed claims protect compositions of ART27.13 dispersed in polyethylene glycol and are expected to extend patent protection through 2041.
ART27.13 is currently in two Phase 2 studies: CAReS for cancer-related anorexia (搜索) and the DREAM study for glaucoma (搜索) or ocular hypertension (搜索).
Artelo Biosciences (搜索), Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways, announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a U.S. patent application covering the intended commercial formulation of ART27.13, the company's peripherally selective cannabinoid agonist. The allowed claims protect compositions of ART27.13 dispersed in polyethylene glycol, including the company's intended commercial formulation, and are expected to extend patent protection for ART27.13 through 2041.
"This U.S. Notice of Allowance and near-term expectation of the issuance of the patent further strengthens the intellectual property foundation supporting ART27.13 and its long-term development potential," said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences (搜索). "As ART27.13 advances in multiple Phase 2 studies, we believe protecting the intended commercial formulation is an important step in building value around the program and preserving opportunities across multiple indications."
ART27.13 and Its Clinical Programs
ART27.13 is a novel benzimidazole derivative and dual cannabinoid agonist initially developed by AstraZeneca plc. The drug has been evaluated in seven clinical studies with over 280 participants and is being developed as a once-daily, orally administered agent that selectively targets peripheral CB1 (搜索) and CB2 (搜索) receptors. This peripheral selectivity is designed to enable systemic metabolic effects while minimizing central nervous system-mediated toxicity.
The investigational drug is currently being evaluated in two Phase 2 studies. The Cancer Appetite Recovery Study (CAReS) is evaluating ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Interim Phase 2 data revealed that patients who had lost at least 5% of body weight and were 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%. In the Phase 1 stage, the drug was well tolerated and showed early signs of stabilizing or reversing weight loss in more than 60% of participants. Notably, there is currently no FDA-approved treatment for cancer anorexia cachexia syndrome.
Expanding into Ophthalmology
ART27.13 is also being evaluated in the DREAM study (Determining the Role of synthetic cannabinoids in Eye pressure And tolerability Measurements), a Phase 2 trial in patients with glaucoma (搜索) or ocular hypertension (搜索). The investigator-led study is funded by Glaucoma UK and the HSC R&D Division, sponsored by the Belfast Health and Social Care Trust, and conducted by the Northern Ireland Clinical Trials Unit. The study is led by Professor Augusto Azuara-Blanco, Clinical Professor of Ophthalmology at Queen's University Belfast and Honorary Consultant Ophthalmologist at Belfast Health and Social Care Trust.
"There remains an urgent need for safe, well-tolerated, and effective new treatments for glaucoma (搜索) that can provide additional options to reduce intraocular pressure and preserve vision," said Professor Azuara-Blanco. "The potential role of peripherally selective cannabinoids in ocular health is an exciting and largely unexplored area. This study is expected to provide important insights into whether ART27.13, which is designed to act outside the central nervous system, can safely lower intraocular pressure without psychotropic side effects."
Glaucoma (搜索) is a leading cause of irreversible blindness, affecting more than 80 million people worldwide. Elevated intraocular pressure (IOP) is the primary modifiable risk factor for glaucoma progression, but existing therapies—mostly topical eye drops—often face limitations related to adherence, local tolerability, and long-term efficacy. In the DREAM study, ART27.13 is being evaluated at a daily dose of 650 µg, with initial results anticipated in the fourth quarter of 2026.
"ART27.13's peripherally selective design may overcome the challenges of CNS adverse effects which has been an issue when other oral or topical cannabinoids have been explored in this indication," said Gorgas. "We are looking forward to announcing initial results from the DREAM study later this year."