Can Fite BioPharma Ltd (CANF)

[Spideyboy]

Confused here. I think they wrote something incorrectly in that quote?

This was already a global pivotal trial agreed with the EMA at least.

Press Release from November 1st, 2016

CAN-FITE ADVANCES TOWARDS A PIVOTAL PHASE III CLINICAL TRIAL IN PSORIASIS WITH PICLIDENOSON (CF101) FOLLOWING REACHING AGREEMENT WITH EMA

"today 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."

"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."

Clearly the same trial.

https://ir.canfite.com/news-events/press-releases/detail/771/can-fite-advances-towards-a-pivotal-phase-iii-clinical

also from a Can-Fite short introductory paper made by the company itself in December 2021.

Piclidenoson Clinical Development
• Phase III in Psoriasis – Topline Results Expected Q1 2022
Can-Fite completed enrollment of ~400 patients with moderate-to-severe psoriasis in its
pivotal Phase III Comfort™ trial based on positive results from an interim analysis of the
data. The trial is designed to establish superiority vs. placebo and non-inferiority vs.
Otezla®, an oral drug that generated $1.9 B in 2020 sales, projected to be $3.4 B by 2026

https://docs.publicnow.com/viewDoc?hash_primary=3150C2317F29DE465022FAA827AD9B8BCCCA630B

Maybe they just messed up in a rush to write the PR, or meant to write that they will approach the EMA with the data, and the FDA with a protocol for a pivotal phase III study? I mean they met the primary end-point with statistical significance. No need to redo a clinical trial when you meet the Primary Endpoint with Statistical Significance.