CanFite's Piclidenoson Positioned For Successful Phase 3 In Psoriasis

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Can-Fite BioPharma Ltd. (NYSEMKT: CANFannounced on November 1, 2016, that the company reached an agreement with the European Medicines Agency (EMA) on the final design of a global pivotal Phase 3 trial for its lead drug candidate, piclidenoson (formerly CF101), in the treatment of psoriasis. Can-Fite intends to initiate the Phase 3 trial in the second half of 2017. I've reviewed the proposed protocol for the trial and I think Can-Fite has positioned themselves well for success in this study. My article below is a brief summary of piclidenoson for the treatment of psoriasis and why I believe the Phase 3 trial has an excellent chance to succeed.

The Phase 3 Trial

The planned Phase 3 trial will be a randomized, double-blind, placebo- and active-controlled study that will investigate the efficacy and safety of daily piclidenoson administered orally compared to Otezla® (apremilast) in approximately 400 patients with moderate-to-severe plaque psoriasis. Can-Fite expects to conduct the study "globally," which will include sites in the U.S. Management will also utilize the A3AR biomarker to screen patients for enrollment in the study. The study is designed to have four arms:

Randomization will be in a 3:3:2:3 ratio. Medication will be taken orally twice daily for 32 weeks in a double-blinded fashion. The primary endpoint will be the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI-75) at week 16 compared to placebo. Important secondary endpoints will be non-inferiority to Otezla® on week 32 and efficacy and safety data for piclidenoson through the extension period of up to 48 weeks of treatment. The trial is expected to initiate during the second half of 2017.

Why I think The Odds Favor Success

The primary endpoint of the EU-centric Phase 3 study will be piclidenoson 2 mg and 3 mg vs. placebo. Based on the data from the company's Phase 2/3 study conducted in the U.S., Europe, and Israel, I believe this endpoint has a very good chance to be met. For example, analysis of the Phase 2/3 data showed statistically significant separation from the placebo during week 20 through 32 (see below).

The Phase 2/3 trial did not show separation at week 16; however, there are two important differences that give me confidence the Phase 3 trial has a much better chance to succeed. Firstly, Can-Fite upped the dose in the Phase 3 study, which now includes a 3 mg piclidenoson arm. A 50% increase in dose should improve the response rate for patients. In Can-Fite's Phase 2 study, a linear effect was observed; the 2 mg dose reported a PASI-50 score of 35% compared to the 1 mg dose at only 21%. Can-Fite did observe a reduced effect with 4 mg and above, but it is likely that the 3 mg arm will show an improved response in the upcoming Phase 3 study. Importantly, Phase 1 and 2 studies show piclidenoson is safe and well-tolerated at doses up to 4 mg.

The second important difference between the Phase 2/3 study and the planned Phase 3 study is the inclusion of the A3AR biomarker as a screen for enrollment. Recall, piclidenoson is an orally bioavailable A3 adenosine receptor (A3AR) agonist. Scientists have discovered that the Gi protein-associated A3AR is found to be over-expressed in inflammatory and cancer cells vs. low expression of the receptor if found in normal cells. The mechanism of action of adenosine agonism in inflammatory conditions involves deregulation of the nuclear factor-κB (NF-κB) and the Wnt signal transduction pathways resulting in apoptosis of inflammatory cells.

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