Can-Fite BioPharma has received a notice of allowance from the European Patent Office (EPO) accepting the patent application for the company’s new psoriasis treatment Piclidenoson (CF101).
Piclidenoson is a novel adenosine receptor agonist (A3AR) small molecule for oral administration with a favorable therapeutic index proven in Phase 2 clinical studies.
The patent, titled “Pharmaceutical Composition Comprising A3 Adenosine Receptor Agonist (IB-MECA/CF-101) for Treatment of Psoriasis,” (EP 2475371 A1) addresses Can-Fite’s lead drug candidate to treat moderate-to-severe psoriasis.
Piclidenoson will be evaluated in an upcoming Phase 3 clinical trial in Europe, where it will be compared to Otezla (apremilast), a recently approved oral drug developed by Celgene. Can-Fite submitted its Phase 3 trial protocol for Piclidenoson to the European Medicines Agency (EMA) earlier this year.
The Phase 3 trial is a randomized, double-blind, placebo-controlled, study that will evaluate the effectiveness and safety of daily oral doses of Piclidenoson in comparison with Otezla (apremilast).
Piclidenoson will be given twice daily for 32 weeks. The trial’s primary endpoint will be the proportion of patients who achieve a Psoriasis Area and Severity Index (PASI) score response of at least 75 percent (PASI 75) at week 32.
The study will enroll about 370 patients with moderate-to-severe psoriasis in four arms: 1) Piclidenoson 2 mg; 2) Piclidenoson 3 mg; 3) Piclidenoson matching Otezla 30 mg; or 4) Piclidenoson matching a placebo.
“This important psoriasis patent comes at an opportune time, as we are heading into a Phase 3 trial in Europe. A similar patent was granted to Can-Fite in the U.S. last year,” Can-Fite CEO Dr. Pnina Fishman said in a press release.
“We believe our robust global IP portfolio supports our market position, as we look ahead towards potential commercialization and out-licensing deals in our advanced stage indications,” Fishman said.
It’s estimated that 2.4 million Europeans have moderate-to-severe psoriasis, according to the European Federation of Pharmaceutical Industries and Associations.
Besides psoriasis, the drug candidate is simultaneously being evaluated for the treatment of rheumatoid arthritis. A Phase 2 trial was just completed.
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