Oral piclidenoson continues to show efficacy and safety in psoriasis, according to the first Phase 3 data which appears in the Journal of the European Academy of Dermatology and Venereology.
Can-Fite’s piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug that has shown efficacy in Phase II and III psoriasis studies. The drug inhibitis of interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with disease pathogenicity.
Currently, piclidenoson is being evaluated in COMFORT-2 a pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
In the randomized phase 3 clinical trial (COMFORT-1), piclidenoson met the study’s primary endpoint which was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI-75) at Week 16 (3 mg BID dose: PASI 75 rate of 9.7% vs. 2.6% for piclidenoson vs. placebo). Piclidenoson’s efficacy continued to increase throughout the study period in a linear manner with an excellent safety and tolerability profile.
Based on preclinical efficacy data, piclidenoson is also being co-developed for the treatment of Lowe Syndrome, a rare genetic disease.
