ART27.13

Dual Cannabinoid Receptor Agonist for Cancer-Related Anorexia and Cachexia

ART27.13, a dual cannabinoid receptor (GPCR) agonist, is being developed as a once-a-day, orally administered, benzimidazole derivative, highly potent, peripherally restricted new chemical entity, targeting CB1and CB2 receptors (learn more about CB1/CB2), with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients.

Artelo has announced positive clinical results in Phase 1 and Phase 2 studies of ART27.13.

Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome.

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

 

CAReS Phase 1 Results

ART27.13 was found to be well-tolerated with sustained weight loss reversed or arrested in 64% of treated patients

Change in Weight

14/22 (64%) of patients reported weight stabilization or weight gain observed at day 28

Adverse Events

No events considered dose limiting toxicities and no fatal adverse events related to trial treatment were observed (up to 12-week dosing)

Data presented by Professor Barry J. A. Laird, Edinburgh Cancer Centre, at the 17th International Conference on Sarcopenia, Cachexia, & Wasting Disorders, December 6-8, 2024.

CAReS Phase 2 (Interim) Results

ART27.13 was found to show efficacy versus placebo in lean body mass, weight gain, activity, and well-tolerated up to 1300 μg per day (similar safety profile to Phase 1)

Weight changes pre-, during and post-treatment

CAReS inclusion criteria required a documented >5% weight loss during the prior 6 months

Change in Weight

At end of treatment there was an average 6% increase in weight in patients who escalated to 1300 ug and a 5% decrease in patients who received placebo

 

Change in Activity

Activity data captured by MotionWatch showed an increase in total activity for patients on active treatment compared to those on placebo

Data presented by Professor Barry J. A. Laird, Professor of Palliative Medicine, University of Oslo and Oslo University Hospital/Radium Hospital, at the 8th Cancer Cachexia Conference, September 27, 2025.

Formulation and Intellectual Property

  • Formulated as once daily oral capsules
  • Multiple patents issued and pending applications
  • 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
  • No regulatory authorized medicine for CACS in US, UK, or EU (no current FDA, MHRA or EMA approved therapies)
  • 2020 ASCO Guidelines recommend no specific pharmacological intervention as standard of care
  • Potential for expansion in anorexia beyond cancer

Cancer Anorexia: The Unmet Need

 

The CAReS Trial

Currently, ART27.13 is the focus of a phase 1/2, 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 currently has 18 sites in five countries participating.

CAReS Trial
Learn More About the CAReS Trial

References:

  • Nonsteroidal selective androgen receptor modulator Ostarine in cancer cachexia. Zilbermint MF, Dobs AS, Future Oncol. 2009 Oct; 5(8):1211-20;
  • 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;
  • 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;
  • 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,
  • Management of Cancer Cachexia: ASCO Guideline, May 2020;
  • Megestrol acetate for treatment of anorexia-cachexia syndrome. Cochrane Database of Systematic Reviews 2013, Issue 3. Art. No.: CD004310.
  • https://www.ncbi.nlm.nih.gov/pubmed/22249824
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6027162/
  • Source: AstraZeneca, adMare. Data on file