title: Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial.
abstract: CF101, an adenosine A3 receptor agonist, is an orally bioavailable small molecule drug presenting an anti-psoriatic effect demonstrated in a Phase 2 clinical trial in psoriasis patients.<BR />
  
  
  
  To evaluate the safety and efficacy of CF101 treatment in a Phase 2/3 study in patients with moderate to severe plaque-type psoriasis.<BR />
  
  
  
  This multicenter, double-blind, 2-segment, placebo-controlled study randomized subjects with moderate to severe plaque psoriasis to CF101 1 or 2 mg, or placebo twice daily. At either week 12 (Segment 1) or 16 (Segment 2), the placebo group crossed over to CF101 BID through week 32 in an open-label fashion. At week 12, following an interim analysis, the CF101 1mg group was discontinued due to futility. The primary endpoint was proportion of patients achieving &ge;75% improvement in Psoriasis Area Severity Index (PASI 75). Efficacy testing was performed using the Cochran-Mantel Haenszel test, the primary analysis of PASI 75 was performed at the 0.035 significance level.<BR />
  
  
  
  CF101 had an excellent safety profile at all tested dosages with a profile similar to the placebo group. The most common adverse events were infections and gastrointestinal events, and there was no cumulative intolerance over the 32-week dosing period. The study did not meet the primary endpoint of PASI 75 at week 12 (2 mg: 8.5% vs. placebo: 6.9%, <em>P</em>=0.621). However, at week 32, PASI mean percent improvement with CF101 2 mg was 57% (<EM>P</EM>&LT;0.001) compared to baseline, with linear improvement in PASI 50 (63.5%), 75 (35.5%), 90 (24.7%), and 100 (10.6%).<BR />
  
  
  
  Oral CF101 was found to be safe and very well tolerated, demonstrating evidence of efficacy in patients with moderate to severe plaque psoriasis through 32 weeks of treatment.<BR /><BR /> <em>J Drugs Dermatol</em>. 2016;15(8):931-938.
authors.forename: Michael
authors.initials: M
authors.lastname: David
authors.forename: Dimitar Konstantinov
authors.initials: DK
authors.lastname: Gospodinov
authors.forename: Nicola
authors.initials: N
authors.lastname: Gheorghe
authors.forename: Grisha Stefanov
authors.initials: GS
authors.lastname: Mateev
authors.forename: Mariyana Venelinova
authors.initials: MV
authors.lastname: Rusinova
authors.forename: Evgeniya
authors.initials: E
authors.lastname: Hristakieva
authors.forename: Laura Gheuca
authors.initials: LG
authors.lastname: Solovastru
authors.forename: Rita V
authors.initials: RV
authors.lastname: Patel
authors.forename: Calin
authors.initials: C
authors.lastname: Giurcaneanu
authors.forename: Mariela Chepileva
authors.initials: MC
authors.lastname: Hitova
authors.forename: Anca Ioana
authors.initials: AI
authors.lastname: Purcaru
authors.forename: Beti
authors.initials: B
authors.lastname: Horia
authors.forename: Iliya Iliev
authors.initials: II
authors.lastname: Tsingov
authors.forename: Rumyana Kaloferova
authors.initials: RK
authors.lastname: Yankova
authors.forename: Miroslava Ilieva
authors.initials: MI
authors.lastname: Kadurina
authors.forename: Michal
authors.initials: M
authors.lastname: Ramon
authors.forename: Maria
authors.initials: M
authors.lastname: Rotaru
authors.forename: Olga
authors.initials: O
authors.lastname: Simionescu
authors.forename: Vasile
authors.initials: V
authors.lastname: Benea
authors.forename: Zdravka Velichkova
authors.initials: ZV
authors.lastname: Demerdjieva
authors.forename: Maria Rodica
authors.initials: MR
authors.lastname: Cosgarea
authors.forename: Horia Silviu
authors.initials: HS
authors.lastname: Morariu
authors.forename: Ziv
authors.initials: Z
authors.lastname: Michael
authors.forename: Patricia
authors.initials: P
authors.lastname: Cristodor
authors.forename: Carmen
authors.initials: C
authors.lastname: Nica
authors.forename: Michael H
authors.initials: MH
authors.lastname: Silverman
authors.forename: David R
authors.initials: DR
authors.lastname: Bristol
authors.forename: Zivit
authors.initials: Z
authors.lastname: Harpaz
authors.forename: Motti
authors.initials: M
authors.lastname: Farbstein
authors.forename: Shira
authors.initials: S
authors.lastname: Cohen
authors.forename: Pnina
authors.initials: P
authors.lastname: Fishman
mesh_terms: D000241:Adenosine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000175:diagnosis* / Q000188:drug therapy*; D013223:Statistics as Topic; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C478920:CF101; D000241:Adenosine