Artelo Biosciences has selected Aptus Clinical, a specialist Clinical Contract Research Organization based in the United Kingdom (UK) with particular expertise in oncology, rare diseases and advanced therapies, as its contract research organization (CRO) for the Company’s planned Phase 1b/2a randomized, placebo-controlled trial of ART27.13, its synthetic cannabinoid for the treatment of anorexia and weight loss associated with cancer. This latest agreement builds on earlier collaborations between Artelo and Aptus, which included feasibility studies, protocol design, and clinical site identification and selection. The ART27.13 program will continue to be under the operational stewardship of Artelo’s UK subsidiary at the Alderley Park BioHub in Cheshire.
ART27.13 is a highly potent peripherally selective synthetic dual cannabinoid agonist believed to target peripheral cannabinoid receptors sending a feeding message to the brain. The combined Phase 1b/2a trial is expected to enroll up to 49 subjects at clinical sites within the UK. The study is designed to determine the most effective and well tolerated dose in cancer patients and evaluate activity using criteria such as weight gain, lean body mass, and improvement of anorexia.
“We are excited to expand our relationship with Aptus, which will allow us to leverage their broad experience as well as their understanding of local regulatory processes combined with a wide network of investigators and key opinion leaders,” Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences, said. “We look forward to providing further updates as we commence our Phase 1b/2a trial and advance our cancer anorexia program.”
“We are honored to have been selected by Artelo to help oversee this important trial. Despite the fact that cancer-related anorexia affects about 60% of advanced stage cancer patients, there are no FDA approved drugs for this indication and only a few agents used off-label with limited efficacy,” Steve McConchie, Chief Executive Officer of Aptus Clinical, said. “Clearly, patients deserve better and the profile of Artelo’s product candidate is compelling.”
ART27.13 is a potent, peripherally selective CB1/CB2 synthetic agonist that enables systemic metabolic effects, while minimizing central nervous system mediated side effects. ART27.13 has been previously evaluated in 205 subjects across five Phase 1 studies conducted by AstraZeneca plc. Existing clinical data with ART27.13 suggests meaningful potential for the treatment of cancer-related anorexia and weight loss as ART27.13 demonstrated a statistically significant and dose-proportional increase in body weight. In ongoing consultation with regulatory authorities, Artelo plans to advance ART27.13 as a multi-modal supportive care therapy for cancer patients suffering from anorexia or weight loss.