"We continue to deliver on our clinical and strategic objectives, advancing three differentiated programs with strong potential to address large, underserved markets," said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. "We were very pleased with the interim Phase 2 data with ART27.13 showing restoration in body weight versus continued weight loss in people suffering from cancer-related anorexia. Importantly, this data has attracted meaningful partnering interest from several pharmaceutical companies. In addition, partnering interest continues to expand for ART26.12, our lead FABP5 inhibitor, as more companies become aware of its broad therapeutic potential. With ART26.12's progress toward a multiple ascending dose study, we believe our clinical pipeline is well-positioned to create substantial value for patients and shareholders."
Business Highlights:
ART26.12, Following Successful Single Ascending Dose (SAD) Study, Multiple Ascending Dose (MAD) Study Protocol being Finalized
The MAD study aims to confirm the favorable safety profile and dose-linear pharmacokinetics observed in the SAD study under multiple dose scenarios while providing further information on dosing frequency and biomarker strategy.
Preliminary food-effect results support future development with dosing in either fed or fasted states.
ART27.13, Positive Interim Phase 2 CAReS Data Driving Partnering Interest
Interim Phase 2 Cancer Appetite Recovery Study (CAReS) results demonstrated meaningful efficacy, safety, and functional benefit in cancer-related anorexia and weight loss.
Patients receiving top dose ART27.13 achieved an average +6.4% weight gain versus a -5.4% loss on placebo, showed +4.2% lean body mass increase, and improved activity levels aligned with potential regulatory endpoints.
ART27.13 was well tolerated with predominantly mild or moderate adverse events.
Following positive Phase 2 results and coverage by UK and USA media outlets, Artelo has received multiple expressions of potential collaboration interest from global and regional pharmaceutical companies.
European Patent Office issued a Notice of Allowance covering the intended commercial formulation of ART27.13 through 2041.
ART12.11, First-in-Human Study Expected to Commence in 1H 2026
Received clear guidance from MHRA, the regulatory authority in the UK, on a streamlined pathway to the clinic. First-in-human study anticipated to start in first half of 2026.
Presentation of new preclinical data at the 35th Annual International Cannabinoid Research Society Symposium demonstrating an antidepressant-like activity on par with and improved cognitive benefits over sertraline (Zoloft®); a leading standard-of-care therapy.
Publication of new preclinical data conducted in collaboration with researchers at Western Ontario University in Progress in Neuro-Psychopharmacology and Biological Psychiatry, which highlighted that ART12.11 significantly outperformed cannabidiol (CBD) alone in reducing stress-induced depression and anxiety symptoms, while ...
