Patients in Artelo’s CAReS Phase 2 trial of ART27.13, a once-daily dual cannabinoid agonist for cancer-related anorexia, gained an average of more than 6% body weight while placebo recipients lost about 5% over the same interval. The drug has been tolerated at doses up to 1300 micrograms daily, with a safety profile consistent with its Phase 1 experience. Separately, ART26.12, Artelo’s peripherally acting FABP5 inhibitor, showed no safety concerns up to a 1050 mg single dose in a Phase 1 SAD study, with linear, predictable exposure and a preliminary read suggesting dosing flexibility in fed or fasted states.
The company is presenting expanded ART26.12 SAD and food-effect data, along with interim CAReS Phase 2 results for ART27.13, at a cannabinoid drug development meeting. Together, the updates signal two parallel clinical tracks: advancing ART26.12 into multiple-ascending-dose and proof-of-principle studies in chemotherapy-induced peripheral neuropathy, and continuing the randomized, blinded CAReS program to define efficacy signals for ART27.13 across weight, lean mass, and activity measures in patients with cancer-associated anorexia and weight loss.
Strategically, this is a bet on supportive care niches where traditional options are limited and regulatory expectations are shifting toward demonstrable functional benefit. In cancer anorexia, where no therapies are approved in the US, UK, or EU and megestrol or dronabinol are often used with mixed outcomes, a consistent and tolerable oral agent that moves body weight meaningfully could be positioned for a relatively streamlined path—if the signal translates into gains in lean mass, physical function, and patient-reported appetite. The pharmacology here matters: peripherally selective CB1/CB2 engagement aims to drive metabolic effects while minimizing CNS toxicity that has complicated earlier cannabinoid approaches. For ART26.12, the non-opioid, peripherally acting mechanism and clean, linear PK are well aligned with regulators’ push away from centrally acting analgesics. A minimal food effect reduces variability and simplifies dose standardization across sites, which can be decisive in PoP readouts where effect sizes are modest and placebo response is a known risk.
For sites and CROs, both programs offer operational advantages: once-daily oral dosing, the potential to avoid fed/fasted constraints, and the use of objective measures such as body weight that can be captured reliably. The execution challenge will be in the details. Cachexia populations are frail with high attrition; protocols that rely on DXA for lean mass, activity monitors, or frequent ePROs must balance data richness with feasibility. Endpoint selection will be scrutinized. Regulators are likely to emphasize clinically meaningful change—percent weight gain sustained over time, preservation of lean mass, improvements in appetite scales, and functional metrics—over short-term weight deltas alone. In CIPN, choice of PRO instruments, timing relative to chemotherapy cycles, and stratification by neurotoxic regimens will influence signal detectability and generalizability.
Next, watch for full Phase 2 CAReS data on durability of weight change, lean mass, quality-of-life and activity outcomes, and dose-response at the higher exposure range. A pivotal strategy will likely hinge on confirming functional benefits and selecting an appropriate comparator, with regional differences in standard of care shaping design. For ART26.12, the move into MAD and PoP will test whether the PK simplicity translates into a clinically relevant analgesic effect without CNS burden; drug–drug interaction work and exposure–response modeling will be key. The risks are typical for the category: heterogeneity across tumor types and treatments, placebo effects in symptom trials, regulatory caution around cannabinoid pharmacology, and payer scrutiny of supportive care endpoints. If Artelo can convert these interim signals into durable, functionally meaningful outcomes, it could open two distinct, under-served markets with relatively efficient trial designs.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
