Announcement • Aug 18
Artelo Biosciences Receives Notice Of Allowance For U.S. Patent Covering Intended Commercial Formulation Of ART27.13 Artelo Biosciences, Inc. has received a Notice of Allowance for a U.S. patent application covering the intended commercial formulation of ART27.13, the Company’s peripherally selective cannabinoid agonist currently being evaluated in the Phase 2 CAReS trial for cancer-related anorexia and the Phase 2 DREAM study in patients with glaucoma or ocular hypertension. The allowed claims protect compositions of ART27.13 dispersed in polyethylene glycol, including the Company’s intended commercial formulation. This development marks a major milestone in Artelo’s global intellectual property strategy and positions the Company for long-term value creation. ART27.13 is being evaluated in the Phase 2 portion of CAReS trial targeting cancer-related anorexia. The investigational drug was well tolerated in the Phase 1 stage and showed early signs of stabilizing or reversing weight loss in more than 60% of participants. Interim results from the Phase 2 portion of CAReS demonstrated the ability of the drug to reverse cancer-related anorexia in all patients taking the highest dose whereas all the participants on placebo continued to lose weight throughout the study. ART27.13 is also being evaluated in the DREAM study, a Phase 2 in patients with glaucoma or ocular hypertension. The investigator-led study, funded by Glaucoma UK and the HSC R&D Division, is evaluating ART27.13's potential as a once-daily, orally administered treatment to reduce intraocular pressure, with initial results anticipated in the Fourth Quarter of this year. ART27.13 is a novel benzimidazole derivative and dual cannabinoid agonist. Initially developed by AstraZeneca plc, ART27.13 has been in seven clinical studies with over 280 participants. It is being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to reduce muscle degeneration while improving body weight, appetite, and quality of life in cancer patients. A statistically significant and dose-dependent increase in body weight was observed in people with back pain who were otherwise healthy. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Artelo is conducting a Phase 2 named the Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Interim Phase 2 data revealed patients who had lost at least 5% of body weight to be included in CAReS and titrated to the highest ART27.13 dose (1300 µg) achieved an average +6% weight gain over 12 weeks, while patients on placebo lost an additional ~5%. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. In addition to CAReS, ART27.13 is also being evaluated in a Phase 2 study in people with glaucoma at a daily dose of 650 µg. Announcement • Aug 11
Artelo Biosciences, Inc. Enrolls First Patient in Phase 2 Clinical Trial Evaluating ART27.13 for Treatment of Glaucoma Artelo Biosciences, Inc. announced the first patient has been dosed in the DREAM study (Determining the Role of synthetic cannabinoids in Eye pressure And tolerability Measurements), which will evaluate the effects of Artelo’s orally administered synthetic cannabinoid, ART27.13, in patients with glaucoma or ocular hypertension. ART27.13, a peripherally selective synthetic cannabinoid receptor agonist, represents a novel therapeutic approach aimed at modulating intraocular pressure (IOP) through activation of cannabinoid receptors located in ocular tissues. Funding for the DREAM study is being provided by Glaucoma UK and the HSC R&D Division. The study is sponsored by the Belfast Health and Social Care Trust and is being conducted by the Northern Ireland Clinical Trials Unit. Glaucoma is a leading cause of irreversible blindness, affecting more than 80 million people worldwide. Elevated IOP is the primary modifiable risk factor for glaucoma progression, but existing therapies—mostly topical eye drops—often face limitations related to adherence, local tolerability, and long-term efficacy. ART27.13 is a novel benzimidazole derivative and dual cannabinoid agonist. Initially developed by AstraZeneca plc, ART27.13 has been in seven clinical studies with over 280 participants. It is being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to reduce muscle degeneration while improving body weight, appetite, and quality of life in cancer patients. A statistically significant and dose-dependent increase in body weight was observed in people with back pain who were otherwise healthy. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Artelo is conducting a Phase 2 named the Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Interim Phase 2 data revealed patients who had lost at least 5% of body weight to be included in CAReS and titrated to the highest ART27.13 dose (1300 µg) achieved an average +6% weight gain over 12 weeks, while patients on placebo lost an additional approx. 5%. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. In addition to CAReS, ART27.13 is also being evaluated in a Phase 2 study in people with glaucoma at a daily dose of 650 µg. Announcement • Jul 17
Artelo Biosciences, Inc. Announces Results from Nonclinical Osteoarthritis Study Supporting ART26.12 as Potential First-In-Class New Therapy for Chronic Pain Conditions Artelo Biosciences, Inc. announced new data supporting the therapeutic potential of ART26.12, its proprietary and selective fatty acid binding protein 5 (FABP5) inhibitor, as a novel product candidate for the treatment of osteoarthritis (OA) pain. In the nonclinical OA study, oral administration of ART26.12 significantly reduced osteoarthritis-associated pain behaviors following both acute and chronic dosing over a 4-week period, demonstrating efficacy comparable to naproxen, a widely prescribed nonsteroidal anti-inflammatory drug (NSAID) used to treat OA. ART26.12 produced distinct changes in endocannabinoids and other related bioactive lipids and proteins compared to naproxen, supporting a novel mechanism of action for ART26.12. Animals treated with ART26.12 exhibited significantly less stomach tissue damage, including non-glandular hyperkeratosis, compared to those receiving naproxen. Non-glandular hyperkeratosis is considered an early indicator of erosions and gastric ulcers, a well-recognized and potentially serious complication associated with chronic NSAID use. These findings suggest ART26.12 may offer effective pain relief with the potential for an improved gastrointestinal safety profile. Long-term treatment options for OA remain constrained by the safety concerns associated with chronic NSAID use, including gastrointestinal complications that contribute to significant morbidity and healthcare costs each year. These limitations highlight the need for differentiated therapies, and new preclinical findings further validate FABP5 as a promising target for the treatment of chronic pain while reinforcing the broad therapeutic potential of ART26.12. The data demonstrated that inhibition of FABP5 significantly alleviated osteoarthritis-associated pain, expanding the potential clinical utility of ART26.12 beyond neuropathic pain into one of the largest and most prevalent chronic pain markets. ART26.12 delivered pain relief comparable to naproxen while exhibiting significantly less gastric tissue damage in preclinical studies, supporting the potential for an improved gastrointestinal safety profile. Collectively, these findings further support the continued development of ART26.12 as a differentiated, non-opioid pain therapy with the potential to address multiple chronic pain indications through its novel mechanism of action. Preparations are underway for conducting a clinical multiple ascending repeat dose study to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 in healthy volunteers. Artelo anticipates enrollment will commence during the fourth quarter of this year. ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). Human studies with ART26.12 have demonstrated a favorable safety profile with no serious adverse events, as well as predictable, linear pharmacokinetics and dosing flexibility in both fed and fasted states. Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. In addition to ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. 
