Artelo Biosciences wins US patent allowance for ART27.13 formulation

Artelo Biosciences has received a Notice of Allowance from the US Patent and Trademark Office for a patent 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 the company says the grant is expected to extend patent protection through 2041.

The Solana Beach-based company is currently running two Phase 2 studies with ART27.13: the CAReS trial targeting cancer-related anorexia and cachexia, and the DREAM study evaluating the drug in patients with glaucoma or ocular hypertension. Securing IP on the commercial formulation at this stage adds a layer of exclusivity that could become commercially significant if either programme reaches late-stage development or attracts a licensing partner.

The clinical picture

Interim data from the Phase 2 portion of CAReS reported that patients titrated to the highest dose of ART27.13, at 1,300 micrograms, achieved an average weight gain of approximately 6% over 12 weeks, while those on placebo lost a further 5% over the same period. In Phase 1, the drug was described as well tolerated and showed early signs of stabilising or reversing weight loss in more than 60% of participants. The company notes there is currently no FDA-approved treatment for cancer anorexia cachexia syndrome, which represents a substantial unmet need in supportive oncology care.

ART27.13 was originally developed by AstraZeneca and has now been evaluated in seven clinical studies involving more than 280 participants. Its mechanism targets peripheral CB1 and CB2 cannabinoid receptors while seeking to avoid central nervous system effects, which have historically limited the clinical utility of cannabinoid-based therapeutics.

The DREAM glaucoma study is investigator-led, funded by Glaucoma UK and the HSC R&D Division, and evaluates ART27.13 as a once-daily oral agent to reduce intraocular pressure. Initial results are anticipated in the fourth quarter of 2026.

Gregory Gorgas, president and chief executive of Artelo, said the notice "further strengthens the intellectual property foundation supporting ART27.13 and its long-term development potential" and described protecting the commercial formulation as "an important step in building value around the programme."

Market and competitive context

The cancer cachexia space has long been considered difficult to address pharmacologically. Despite the high prevalence of cachexia-associated weight loss in oncology patients, regulatory approvals have been elusive, and several late-stage programmes from other companies have not advanced. Anamorelin, a ghrelin receptor agonist approved in Japan for cancer cachexia, has not secured approval in the US or Europe, which illustrates the regulatory challenge Artelo and others in the space continue to face.

For ART27.13's ocular indication, the compound would compete in a well-served category where prostaglandin analogues and beta-blockers are generic standards of care. A once-daily oral agent with a novel mechanism could differentiate on patient convenience if intraocular pressure reduction data proves competitive, though proof of concept at Phase 2 will be closely scrutinised.

The patent allowance is a positive procedural development rather than a clinical one, and investors will be watching fourth-quarter readouts from DREAM and ongoing CAReS data disclosures as the more material near-term catalysts for the programme.