ART27.13

High-Potency Cannabinoid Agonist Program for Cancer-related Anorexia and Weight Loss

Scientific and Clinical Validation

  • Dual CB1/CB2 receptor potent full agonist
  • 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/2a study in process (CAReS Trial)
  • Phase 2a topline data expected mid 2022

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)

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). 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 is currently enrolling patients at numerous sites.

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