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- Can-Fite BioPharma Ltd (NYSE:CANF) announced topline results from the COMFORT Phase 3 trial of Piclidenoson in more than 400 adults with moderate to severe plaque psoriasis.
- The study data show that patients treated with oral Piclidenoson 2 mg or 3 mg twice daily had clinically equivalent efficacy responses.
- At week 16, patients receiving Piclidenoson 3mg demonstrated statistically significant improvement compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response - Piclidenoson 3mg: 9.7% vs. placebo: 2.6%.
- Related: Can-Fite BioPharma Flags Delay In Piclidenoson Data Readout From Psoriasis Study.
- Secondary endpoint parameters at week 32 comparing Piclidenoson to the active control drug, Amgen Inc's (NASDAQ:AMGN) Otezla (apremilast), revealed inferiority related to PASI 75 (17% vs. 26.2%) and PASI 50 (34.1% vs. 49.5%).
- But revealed the superiority of Piclidenoson compared to Otezla in the Psoriasis Disability Index (PDI) (20.5% vs. 10.3%).
- Piclidenoson showed a favorable safety profile.
- Price Action: CANF shares are up 33.8% at $1.19 during the premarket session on the last check Wednesday.