Can-Fite (CANF) Reaches Agreement with EMA on Design of Pivotal Piclidenoson Phase 3 as Psoriasis Treatment
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Can-Fite BioPharma (NYSE: CANF) announced that it has reached an agreement with the European Medicines Agency (EMA) on the final design of a global pivotal Phase III trial for its lead drug candidate, Piclidenoson (CF101), in the treatment of psoriasis. Can-Fite intends to initiate the Phase III trial in the second half of 2017.
The planned Phase III trial is a randomized, double-blind, placebo- and active-controlled study that will investigate the efficacy and safety of daily Piclidenoson administered orally as compared to placebo as its primary endpoint and as compared to apremilast (Otezla®) as its secondary endpoint in approximately 400 patients with moderate-to-severe plaque psoriasis. Medication is to be taken orally twice daily for 32 weeks in a double-blinded fashion. The primary end point will be the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) vs. placebo at week 16. The secondary endpoints will include non-inferiority to Otezla® on week 32 and efficacy and safety data for CF101 through the extension period of up to 48 weeks of treatment. Patients will be selected to the study based on over expression of the A3AR biomarker.
The rationale of comparing Piclidenoson to Otezla®, the recently registered oral drug marketed by Celgene, is based on data from Can-Fite's prior Phase II/III study that showed at weeks 24 and 32, Piclidenoson's efficacy as measured by PASI compares well to Otezla® in its Phase III trial.
"The higher dosage of Piclidenoson together with the utilization of A3AR as a predictive biomarker for patient selection are expected to be important in yielding a faster and efficacious response," stated Can-Fite CEO Dr. Pnina Fishman. "We believe the agreed study design for this pivotal Phase III trial positions us well to demonstrate Piclidenoson's superior and faster accumulation of efficacy. Given that Piclidenoson has exhibited excellent safety in prior clinical trials, we believe that this presents an opportunity to treat patients who need to use drugs for a long time for this chronic disease."
The global psoriasis market is estimated to reach $9 billion by 2018 (Visiongain), and Otezla® sales are estimated to be $2.35 billion by 2020 (DrugAnalyst).
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 including rheumatoid arthritis (completed Phase II) and psoriasis (completed Phase II/III).
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