Artelo Biosciences has dosed the first patient in the Phase II DREAM study assessing ART27.13 as a potential treatment for people with glaucoma or ocular hypertension.
The study is designed to assess whether orally administered ART27.13, a synthetic cannabinoid, can influence intraocular pressure through its activity at cannabinoid receptors in eye tissue.
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It is sponsored by the Belfast Health and Social Care Trust, with research operations run by the Northern Ireland Clinical Trials Unit.
Funding support has been provided by Glaucoma UK and the Health and Social Care research and development (HSC R&D) division.
Queen’s University Belfast ophthalmology clinical professor and Belfast Health and Social Care Trust honorary consultant ophthalmologist Augusto Azuara-Blanco is leading the study.
ART27.13 is described as a peripherally selective synthetic cannabinoid receptor agonist.
Artelo Biosciences president and CEO Gregory Gorgas said. “We are excited to announce this fully funded Phase II clinical study, evaluating ART27.13 in glaucoma, has enrolled its first patient. The DREAM study has the potential to demonstrate whether an orally active cannabinoid has a role in managing intraocular pressure.
“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. We are looking forward to announcing initial results from the DREAM study later this year.”
ART27.13, initially developed by AstraZeneca, is a benzimidazole derivative and dual cannabinoid agonist.
It has been assessed in seven previous clinical studies, involving more than 280 participants.
In July 2024, the US Food and Drug Administration approved Artelo Biosciences’ investigational new drug application, enabling a Phase I trial for the pharma company’s fatty acid binding protein (FABP) inhibitor.
