Can-Fite BioPharma has enrolled and dosed the first patient in its Phase III Comfort trial of Piclidenoson in psoriasis in Israel.
The trial intends to investigate the efficacy and safety of Piclidenoson (CF101) in comparison to Apremilast (Otezla) and placebo for the treatment of psoriasis.
It is expected to enrol 407 patients with moderate-to-severe plaque psoriasis, which accounts for up about 90% of psoriasis cases within five countries in Europe, Israel and Canada.
During the trial, Piclidenoson will be administered daily and orally to the patients.
In addition, initiation of the Comfort will allow Can-Fite to receive a milestone payment of €300,000 from Gebro under a newly reached agreement between the companies.
As part of the deal, Gebro will distribute Piclidenoson upon regulatory approval in Spain, Austria and Switzerland.
Can-Fite BioPharma CEO Dr 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 lifetime.”
Piclidenoson is a new A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favourable therapeutic index demonstrated in previous Phase II clinical studies.
The drug is currently being studied for the treatment of autoimmune inflammatory diseases.
A Phase III trial is being conducted to examine Piclidenoson as a first-line treatment and to replace MTX for the treatment of rheumatoid arthritis.