Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial
August 2016 | Volume 15 | Issue 8 | Original Article | 931 | Copyright © August 2016
Michael David MD,a Dimitar Konstantinov Gospodinov MD,b Nicola Gheorghe MD,c Grisha Stefanov Mateev MD,d Mariyana Venelinova Rusinova MD,e Evgeniya Hristakieva MD,f Laura Gheuca Solovastru MD,g Rita.V. Patel MD,h Calin Giurcaneanu MD,i Mariela Chepileva Hitova MD,j Anca Ioana Purcaru MD,j Beti Horia MD,k Iliya Iliev Tsingov MD,l Rumyana Kaloferova Yankova MD,m Miroslava Ilieva Kadurina MD,n Michal Ramon MD,o Maria Rotaru MD,p Olga Simionescu MD,q Vasile Benea MD,r Zdravka Velichkova Demerdjieva MD,s Maria Rodica Cosgarea MD,t Horia Silviu Morariu MD,u Ziv Michael MD,v Patricia Cristodor MD,w Carmen Nica MD,x Michael H. Silverman MD,y David R. Bristol PhD,y Zivit Harpaz MSc,y Motti Farbstein BSc,y Shira Cohen MSc,y and Pnina Fishman PhDy
aRabin Medical Center, Beilinson, Petach-Tikva, Israel;
bUMHAT D-r Georgi Stranski EAD, Pleven, Bulgaria;
cSpitalul Clinic Judetean de Urgenta “Sf. Apostol Andrei” Constantal. Constanta, Romania;
dDCC “Fokus-5”-MIOC, EOOD, Sofia, Bulgaria;
eCentrul Medical de Diagnostic si Tratament Ambulator Neomed SRL Brasov, Brasov, Romania;
fSpitalul Clinic Judetean de Urgenta Sibiu, Sibiu, Romania;
gUMHAT Stara Zagora EAD, Zagora,Bulgaria;
hCenter for Skin and Venereal Diseases Ltd, Sofia, Bulgaria;
iMHAT Doverie AD Department of Gastroenterology Sofia, Bulgaria;
jCentrul Medical de Diagnostic, Brasov, Romania;
kMount Sinai School of Medicine, New York, NY;
lDCC “Sveti Georgi” EOOD-Plovdiv, Plovdiv, Bulgaria;
mCentrul Medical SANA SRL, Bucuresti, Romania;
nMHAT Varna at MMA Sofia, Varna, Bulgaria;
oRambam Medical Center, Haifa, Israel;
pSpitalul Clinic Municipal de Urgenta Timisoara, Timisoara, Romania;
qCentrul Medical Unirea SRL, Bucuresti, Romania;
rSpitalul Clinic Dr. Victor Babes, Bucuresti, Romania;
sMHAT Tokuda Hospital Sofia, Sofia, Bulgaria;
tSpitalul Clinic Dr. Victor Babes, Bucuresti, Romania;
uSpitalul Clinic Judetean Mures, Jud. Mures, Romania;
vHa'emek Medical Center, Afula, Israel;
wSpitalul Clinic Judetean Mures, Jud. Mures, Romania;
xCentrul Medical Unirea SRL, Bucuresti, Romania;
yCan-Fite BioPharma Ltd., Kiryat-Matalon, Petach-Tikva, Israel
OBJECTIVE: To evaluate the safety and efficacy of CF101 treatment in a Phase 2/3 study in patients with moderate to severe plaque-type psoriasis.
METHODS: 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 ≥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.
RESULTS: 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%, P=0.621). However, at week 32, PASI mean percent improvement with CF101 2 mg was 57% (P<0.001) compared to baseline, with linear improvement in PASI 50 (63.5%), 75 (35.5%), 90 (24.7%), and 100 (10.6%).
CONCLUSIONS: 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.
J Drugs Dermatol. 2016;15(8):931-938.