A southern California-based clinical-stage biopharmaceutical company has given the first dose in a study focusing on treating cancer-related anorexia and weight loss.
On Monday, La Jolla-based Artelo Biosciences announced that a patient in its Phase 1/2 Cancer Appetite Recovery Study (CAReS) had received their first dose of ART27.13 in Edinburgh, Scotland.
Targeting CB Receptors
According to Artelo, the ART27.13 formulation is a “highly potent, peripherally restricted synthetic, dual GPCR agonist” that they believe targets the CB1 and CB2 cannabinoid receptors.
In 2020, Artelo received U.K. Ethics Committee approval to commence the CAReS study with Barry J.A. Laird of the Institute of Genetics and Molecular Medicine at the University of Edinburgh and St. Columbia’s Hospice Reader in Palliative Medicine.
Laird is the enrolling physician of the first participating patient in the study.
Artelo, formerly known as Reactive Medical, also has a research collaboration with Trinity College in Dublin to study ART27.13 for treating cancer-related cachexia.
Artelo describes ART27.13 as a “peripherally selective G-Protein Coupled Receptor (GPCR) full antagonist” which the company is developing as a therapy for cancer patients suffering from anorexia and weight loss.
The symptoms affect more than 60 percent of late-stage cancer patients, impacting their quality of life and potentially hastening death.
According to Artelo, weight loss exceeding five percent can signal a poor outcome for cancer patients and a lower response to chemotherapy.
Artelo says that the ART27.13 formula, originally developed by AstraZeneca, can potentially increase appetite and food intake.
“Commencing enrollment and dosing the first patient in our CAReS study marks another important milestone in advancing ART27.13 which we are developing for patients suffering from the devastating effects of cancer associated anorexia—a multi-billion dollar addressable market with no pharmacologic standard of care,” says Senior Artelo VOP and CSO Andrew Yates. “Notably, we anticipate that we will be able to collect initial safety data from Phase 1 of CAReS before the end of this year, which will determine the most effective and safest dose of ART27.13 to utilize in Phase 2 of the study.”
Yates says that ART27.13 has previously demonstrated weight gain in subjects with lower back pain.
Encouraging Results
According to Artelo, ART127.13 has demonstrated a “statistically significant and dose-dependent increase in body weight” in five Phase 1 trials involving more than 200 healthy subjects.
Artelo says that changes in body weight were not related to fluid retention.
The drug’s distribution enables “systemic metabolic effects” while minimizing mediated toxicity to the central nervous system, reports Artelo.
In Phase 1 of the CAReS study, Artelo will research the safest and most effective ART27.13 dose to use in Phase 2.
During Phase 2, Artelo will determine point estimates of the formulation’s activity regarding lean body mass, weight gain, and improvement of anorexia.
Artelo plans to enroll up to 24 patients in Phase 1 and 25 participants in Phase 2.
“This is an exciting time for a clinical study with Artelo’s lead development drug,” says Lead Investigator Barry J.A. Laird, M.D. “So many patients have suffered with substandard options to address the profound weight loss from cancer. With ART27.13, there are grounds for optimism that loss of appetite associated with cancer can be successfully treated.”
Artelo expects to have initial safety data from the CAReS study before the end of 2021.
