Can-Fite BioPharma's ( NYSE: CANF ) oral drug piclidenoson helped reduce severity of symptoms compared to placebo, but failed to beat Amgen's ( AMGN ) Otezla in adult patients with moderate to severe plaque psoriasis in a phase 3 trial.
Plaque psoriasis causes dry, itchy, raised patches (plaques) on the skin.
The study, dubbed COMFORT, included more than 400 adults and evaluated piclidenoson 2-mg or 3-mg twice daily, against placebo.
The company said piclidenoson 2-mg or 3-mg, had clinically equivalent efficacy responses and at week 16, patients receiving the 3-mg dose showed statistically significant improvement in severity of disease compared to placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response (Piclidenoson 3mg: 9.7% vs. placebo: 2.6%). PASI 75 indicates a 75% or greater reduction in PASI scores from the time treatment started.
However, when compared to Amgen's ( AMGN ) Otezla, piclidenoson showed inferiority with respect to change in severity, or PASI, at week 32, which was the secondary goal to beat. PASI 75 (17% for piclidenoson vs. 26.2% for Otezla).
"Based on Piclidenoson’s safety and efficacy data revealed in this trial, we plan to approach the U.S. FDA and the European EMA with a protocol for a pivotal Phase III study for drug approval and registration,” stated Can-Fite CEO Pnina Fishman.
The company noted that piclidenoson was superior to Otezla in the Psoriasis Disability Index (PDI), a questionnaire measuring health-related quality of life, (20.5% for piclidenoson versus 10.3% for Otezla).
Can-Fite noted that piclidenoson had an excellent safety profile overlapping that of placebo and was better when compared to Otezla.
CANF +22.99% to $1.09 premarket June 29
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Can-Fite stock rises 23% as psoriasis drug beats placebo but lags behind Otezla in phase 3 trial