Artelo Biosciences’ cancer anorexia-cachexia syndrome (CACS) drug has helped patients gain weight in a Phase II trial.
During the CAReS study (EudraCT-2020-000464-27), ART27.13, a cannabinoid receptor agonist, was found to trigger weight gain, with those escalated to the drug’s highest dose achieving a 6.38% increase after 12 weeks of treatment. This was compared to a 5.42% average weight loss in the placebo group.
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After one month of oral treatment with the once-daily ex-AstraZeneca asset, patients also experienced a 4.23% increase in lean body mass while participants in the placebo group lost 3.15%.
On top of its impact on body mass, ART27.13 boosted total and weekly activity scores associated with moderate and vigorous exercise – the latter of which could be required by global regulators during the drug approval process. These were measured by a wearable tracking device and standardised questionnaires.
The CB1 and CB2 agonist was also proven safe and tolerable, with 22% of the 32 patients enrolled experiencing adverse events (AEs) associated with the drug. There was one report of severe malaise linked to treatment with ART27.13.
Though the outcome of the CAReS trial was positive, investors were seemingly unconvinced, as Artelo’s share value had dropped by 6% – going from $9.05 at market close on 2 September to $8.48 at market open after the results were released.
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By GlobalDataDespite this, Artelo plans to soldier on with ART27.13’s development. In a 3 September statement, CMO Steven Reich stated that the company is “evaluating plans to advance the ART27.13 programme by starting patients at the highest dose”, which he claims has the greatest efficacy.
The company is hopeful that this data will support a partnership to push the drug into Phase III trials, stating it does not envision the need to internally fund a Phase III trial.
Progressing CACS treatment
Artelo is not the only company developing for CACS, with Pfizer running a Phase III trial of its monoclonal antibody (mAb) ponsegromab to enable registration with the US Food and Drug Administration (FDA). Vistagen is also investigating an intranasal spray, PH284, which showed promise in a Phase IIa study earlier in 2025.
Primarily seen in advanced-stage patients, CACS is driven by a loss of appetite that causes significant losses in body mass. It is characterised by a loss in body weight of at least 5%.
It is currently estimated that cachexia is responsible for 25% of cancer deaths, and the only treatment that is currently prescribed off-label for the condition is megestrol acetate.
Though the progesterone mimic has been FDA-approved for the treatment of anorexia and cachexia, it has not been designated for use in patients with CACS, and its efficacy remains controversial.
