ART27.13

Benzimidazole Derivative for Cancer Anorexia Cachexia Syndrome (CACS)

ART27.13 is being developed as a once-a-day, orally administered, dual G-protein-coupled receptor (GPCR) agonist, benzimidazole derivative, a highly potent, peripherally restricted new chemical entity, targeting CB1and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients.

Originally developed by AstraZeneca plc, ART27.13 has been in clinical studies with over 250 subjects. A statistically significant and dose-dependent increase in body weight was observed in patients with back pain who were otherwise healthy.  Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity.

Having completed a phase 1 study in cancer patients where ART27.13 demonstrated an excellent safety profile, Artelo is now advancing it in the CAReS trial as a supportive care therapy for cancer patients suffering from anorexia and weight loss.  Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome.

Learn more about our Cancer Appetite Recovery Study (CAReS) in cancer anorexia

 

Scientific and Clinical Validation

  • Dual CB1/CB2 receptor potent full agonist (learn more about CB1/CB2)
  • Phase 1 study in subjects with lower back pain that were otherwise healthy demonstrated statistically significant increase in body weight versus drug exposure
  • Phase 1b study completed
  • Phase 2a study ongoing (CAReS Trial)

Formulation and Intellectual Property

  • Formulated as once daily oral capsules
  • Two patents issued and one pending application
  • New Chemical Entity structurally distinct from the phytocannabinoids i.e. THC
  • Peripherally selective (targets receptors in the body, not the brain)

Cancer Anorexia: The Unmet Need

 

Opportunity

  • Cancer Anorexia and Cachexia Syndrome (CACS) affects greater than 60% of advanced stage cancer patients
  • CACS: No regulatory authorized medicine (no current FDA, MHRA or EMA approved therapies exist for CACS)
  • 2020 ASCO Guidelines recommend no specific pharmacological intervention as standard of care
  • Potential future applications in anorexia beyond cancer

The CAReS Trial

Currently, ART27.13 is the focus of a phase 1b/2a, randomized, placebo-controlled trial called the Cancer Appetite Recovery Study (CAReS Trial). The CAReS Trial aims to determine a safe and effective dose as well as activity of ART27.13 in terms of lean body mass, weight gain, and improvement of anorexia. CAReS currently has 18 sites in five countries participating.

CAReS Trial
Learn More About the CAReS Trial

References:

  1. Nonsteroidal selective androgen receptor modulator Ostarine in cancer cachexia. Zilbermint MF, Dobs AS, Future Oncol. 2009 Oct; 5(8):1211-20;
  2. Data from Market Intel Reports 2016 as quoted in Innovus Pharma to Enter the Oncology Supportive Care Market With an Exclusive License to Two GRAS-Listed OTC Compounds for Cachexia and Muscle Growth and Repair From the University of Iowa Research Foundation. Innovus Press Release June 6, 2017, ex-US estimate based upon market forecast model from US sales figures;
  3. Pharmacological management of cachexia in adult cancer patients: a systematic review of clinical trials. Advani, Shailesh M et al., BMC cancer vol. 18,1 1174. 27 Nov. 2018, doi:10.1186/s12885-018-5080-4;
  4. Sánchez‐Lara K, Ugalde‐Morales E, Motola‐Kuba D, Green D. Gastrointestinal symptoms and weight loss in cancer patients receiving chemotherapy. Br J Nutr 2013;109:894‐7,
  5. Management of Cancer Cachexia: ASCO Guideline, May 2020;
  6. Megestrol acetate for treatment of anorexia-cachexia syndrome. Cochrane Database of Systematic Reviews 2013, Issue 3. Art. No.: CD004310.
  7. https://www.ncbi.nlm.nih.gov/pubmed/22249824
  8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6027162/
  9. Source: AstraZeneca, adMare. Data on file

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