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ART26.12 Phase 1 Data Demonstrated No Safety Concerns, Predictable Linear Plasma Exposure, and Options for Dosing in Either Fed or Fasted Conditions
ART27.13 Interim Phase 2 Data Showed Substantial Weight Gain and Activity Improvements in the Treated Patients versus Placebo
SOLANA BEACH, Calif., Oct. 15, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, today announced that Professor Saoirse O'Sullivan, Vice President of Translational Sciences at Artelo Biosciences, is presenting expanded data from Artelo's lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, ART26.12, Single Ascending Dose (SAD) Study at the 8th Annual Cannabinoid & Endocannabinoid Drug Development Summit, taking place October 15–16, 2025, in Boston, Massachusetts. In addition, Professor O'Sullivan will be giving additional insights on ART27.13 development progress in cancer-related anorexia with interim data from the Phase 2 portion of the Cancer Appetite Recovery Study (CAReS).
During the presentation titled Exploring the Clinical Development of the Fatty Acid Binding Protein 5 (FABP5) Inhibitor ART26.12, Professor O'Sullivan plans to share findings from the Company's SAD study and preliminary food effect investigation with ART26.12, which evaluated the safety, tolerability, and pharmacokinetics of its FABP5 inhibitor in healthy volunteers. The SAD study demonstrated that ART26.12 at single doses up to 1050 milligrams was safe and well tolerated. Importantly, ART26.12 exhibited predictable linear dose exposure and showed potential dosing flexibility in either fed or fasted states for future studies. These findings support Artelo's belief that advancement of ART26.12 into multiple ascending dose and proof-of-principle pain studies is warranted.
In addition, Professor O'Sullivan will discuss detailed interim data from the CAReS Phase 2 study. In CAReS, Artelo is evaluating ART27.13, the Company's proprietary dual cannabinoid agonist, versus placebo in a randomized and blinded comparison in cancer patients experiencing anorexia and weight loss. Initial findings show patients receiving up to 1300 micrograms daily on average gained over 6% in weight versus placebo participants losing an additional 5%. Despite receiving up to twice the maximum dose delivered in the Phase 1 stage of CAReS, the safety profile in Phase 2 to date has been similar and well-tolerated. ART27.13 is uniquely positioned as the most clinically advanced small-molecule, orally administered once-daily treatment in development for cancer anorexia. Impacting up to 80% of late-stage cancer patients, currently there are no approved treatments in the US, UK or EU.
Posted In: ARTL
