Can-Fite BioPharma has enrolled and dosed the first patient in its phase 3 Comfort trial to evaluate its small orally bioavailable drug Piclidenoson (CF101) for the treatment of moderate-to-severe plaque psoriasis.
The Comfort Phase III Psoriasis study, is designed to evaluate the efficacy and safety of daily Piclidenoson, administered orally compared to Apremilast (Otezla) and placebo, in 407 patients with moderate-to-severe plaque psoriasis.
The study will be conducted in 5 countries in Europe, Israel and Canada. The first patient has been enrolled and dosed in Israel with enrollment in Europe and Canada expected to follow shortly.
Study initiation will prompt a milestone payment of 300,000 Euro from the recently signed deal with Gebro Holding which will distribute the drug upon regulatory approval in Spain, Austria and Switzerland.
According to Visiongain, the psoriasis therapeutic market is estimated to reach $11.4B in 2020.
Can-Fite CEO Pnina Fishman said: “Dosing the first patient in our Phase III Comfort trial marks a significant milestone for Can-Fite. We believe Piclidenoson is a potentially efficacious and safe option to the patients which need to take drugs chronically for a life time.”
About Piclidenoson (CF101)
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies. Piclidenoson is currently under development for the treatment of autoimmune inflammatory diseases. It is being evaluated in a Phase III study as a first line treatment, to replace MTX, in the treatment of rheumatoid arthritis and a Phase III study in the treatment of moderate-to-severe psoriasis.
Source: Company Press Release