Trial Will Investigate Drug to Curb Cancer Treatment-Related Anorexia, Weight Loss

Patients in three groups of the Cancer Appetite Recovery Study (CAReS) have been enrolled, launching the phase 1b trial of ART27.13 to increase appetite and food intake in patients who are experiencing anorexia (inability to eat) and weight loss as a result of cancer treatment, according to Artelo Biosciences Inc, the pharmaceutical company running the trial.

Prior phase 1 trials of ART27.13 conducted by the pharmaceutical company AstraZeneca showed that the supportive therapy, which works by targeting cannabinoid receptors, led to a statistically significant increase in body weight in healthy individuals.

“The CAReS safety review committee has reviewed the data thus far and has concluded that ART27.13 has been well-tolerated with no serious adverse events attributable to the investigational drug in patients suffering from anorexia associated with cancer,” said Dr. Steven D. Reich, chief medical officer of Artelo, in a press release.

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The CAReS trial will analyze the safety of increasing doses of ART27.13. Researchers will then take that data to determine the best dose for phase 2a of the study, which will further analyze safety as well as how well the drug works.

So far, research has shown that ART27.13 is well-tolerated, and there have been no dose reductions, dose interruptions or medical interventions needed from the drug’s side effects.

“Remarkably, the safety profile of ART27.13 appears more benign among (patients with cancer) participating in CAReS than observed in healthy volunteers in prior phase 1 studies,” Reich said. “Furthermore, we have seen pharmacokinetics consistent with the AstraZeneca experience and an improvement in anorexia from each dose escalation.”

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