Can-Fite BioPharma, Ltd., announced that its lead drug candidate, Piclidenoson (CF101), has shown similar anti-inflammatory efficacy to the biologics currently on the market for the treatment of psoriasis, with the potential advantage of being more safe to use by having fewer side effects.
New findings will be presented at Psoriasis 2016, the 5th Congress of the Psoriasis International Network, taking place July 7–9 in Paris. The oral presentation, “CF101 via A3AR Activation inhibits IL-17 and IL-23,” will be part of the Late Breaking News Session on July 7.
Piclidenoson is a novel, first-in-class small molecule, administered orally, that binds to the Gi protein associated A3 adenosine receptor (A3AR), known to be overexpressed in psoriasis patients. In vitro studies show this binding action produces a strong anti-inflammatory response, inhibiting the pro-inflammatory cytokines interleukin 17 (IL-17) and interleukin 23 (IL-23). Several studies have demonstrated that these molecules play crucial roles in the pathogenesis of psoriasis and constitute powerful therapeutic targets.
Biologic drugs are injectable immunomodulators, currently on the market and in development, that target IL-17 and IL-23 through a similar mechanism of action. Despite good efficacy, these drugs can cause serious side effects by increasing a person’s risk of infection. Clinical studies with the small molecule Piclidenoson in approximately 1,000 people have shown that the drug potentially offers superior safety to biologics.
“We believe that the discovery of this new mechanistic pathway of Piclidenoson will position it as a strong drug candidate to treat psoriasis with potential efficacy similar to biologics on the market today, while potentially offering superior safety as a small molecule oral drug,” Dr. Pnina Fishman, chief executive officer of Can-Fite, said in a news release.
The company recently announced the submission of a protocol design to the European Medicines Agency (EMA) for a Phase 3 clinical trial comparing the safety and efficacy of Piclidenoson to apremilast (Otezla) in patients with moderate-to-severe plaque psoriasis. The potentially pivotal clinical study, which is planned to be conducted globally, is expected to begin this year.