Preclinical PharmacologyThe activity of Piclidenoson as an anti-inflammatory agent has been tested in a number of different experimental models including adjuvant and collagen induced arthritis and inflammatory bowel disease. In all models tested, Piclidenoson induced a robust anti-inflammatory effect measured by clinical and histological disease scores.
Mechanism of ActionPiclidenoson's mechanism of action is A3AR mediated and includes modulation of key signaling proteins, such as PI3K, PKA, PKB/Akt, IKK and NF-kB, resulting in deregulation of the Wnt/β-catenin pathway and inhibition of inflammatory cytokine production.
SafetyThe safety of Piclidenoson has been demonstrated in preclinical studies, including among others, toxicology studies of up to 6 months in mice and 9 months in monkeys. Piclidenoson has an excellent human safety profile, demonstrated in more than 1,200 patients.
EfficacyCan-Fite has tested Piclidenoson in a number of Phase II studies in different diseases. A Phase II study in psoriasis successfully met its primary endpoint showing that the drug effectively ameliorated disease symptoms. In psoriasis, Phase II/III study data showed clinical activity from week 16 till 32, and a Phase III study is ongoing. Moreover, there is a direct correlation between A3AR at baseline and patients' response to Piclidenoson, suggesting its utilization as a predictive biomarker.