Can-Fite stock rises 23% as psoriasis drug beats placebo but lags behind Otezla in phase 3 trial
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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 Piclidenosonâs 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,â 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