ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 949

Safety and Efficacy of CF101 in Rheumatoid Arthritis Patients: A Phase II Study

Rumen M. Stoilov1, Rodina N. Licheva2, Mariyana K. Mihaylova3, Tatiana Reitblat4, Emil A. Dimitrov1, Krasimira M. Shimbova1, Girish Bhatia5, Amit Pispati6, Alexandra Gurman- Balbir7, B R Bagaria5, Boytcho A. Oparanov2, Sari Fishman8, Zivit Harpaz8, Motti Farbstein8, Shira Cohen8, Michael H. Silverman8 and Pnina Fishman8, 1Multiprofile Hospital for Active Treatment “Sv. Ivan Rilski” - EAD, Clinic of Rheumatology, Sofia, Bulgaria, 2Diagnostic Consulting Center, Rheumatology office, Sofia, Bulgaria, 33Diagnostic Consulting Center, Rheumatology office, Sofia, Bulgaria, 4Barzilai Medical Center,, Ashkelon, Israel, 5Malpani Multispeciality Hospital, mumbai, India, 6Bhatia Hospital Medical Research Society, mumbai, India, 7Rambam Medical Center, Haifa, Israel, 8CanFite Biopharma Ltd, Petah Tikva, Israel

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords:

Session Information

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy II: Novel Therapies in Rheumatoid Arthritis - Early in Development

Session Type: Abstract Submissions (ACR)

Background/Purpose:

CF101, is a highly selective A3 adenosine receptor (A3AR) agonist, demonstrated safety and anti-inflammatory effect in Phase 2 clinical studies of rheumatoid arthritis (RA) and Psoriasis. A3AR has been defined as a biological predictive marker, based on a significant correlation found in a former Phase II study, between its over-expression at baseline and positive patients’ response to CF101 treatment.

Methods:

This was a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to assess the efficacy and safety of CF101 1mg, administered orally twice daily to patients with active RA for 12 weeks. Primary efficacy endpoint was ACR 20 response at week 12, with all-cause dropouts considered as non-responders, in the Intent-To-Treat (ITT) population. Secondary efficacy included: ACR 20/50/70 by visit, ITT, using non-responder imputation.

Seventy nine patients were enrolled for the study based on inclusion criteria of A3AR > from 1.5 units and were randomized for two groups receiving CF101 1 mg (n = 42), or Placebo (n = 37).

Results:

CF101 achieved ACR20 of 48.6%, statistically significantly higher than in the Placebo group (25.0%) at week 12 (P=0.0352). CF101 showed superiority in ACR50 and ACR70 values vs. placebo although not statistically significant, most probably due to the low number of patients. Interestingly, ACR20, ACR 50 and ACR 70 response rate at week 12 in patients with no prior systemic therapy, i.e., naïve patients were significantly higher compared to the response of the whole patient population treated with CF101.

The proportion of patients experiencing any adverse event (AE) was similar for both groups (16.7% for the CF101 group and 16.2% for the Placebo group). Two AEs, RA and rash, were considered possibly related to CF101. The majority of AEs were considered to be mild.

Conclusion: CF101 was very well tolerated and reached the primary endpoint in the current study demonstrating clear evidence of efficacy as a monotherapy for 12 weeks in patients with active RA.

Disclosure:

R. M. Stoilov,
None;

R. N. Licheva,
None;

M. K. Mihaylova,
None;

T. Reitblat,
None;

E. A. Dimitrov,
None;

K. M. Shimbova,
None;

G. Bhatia,
None;

A. Pispati,
None;

A. Gurman- Balbir,
None;

B. R. Bagaria,
None;

B. A. Oparanov,
None;

S. Fishman,

Canfite Pharma,

3,

CanFite Biopharma,

1;

Z. Harpaz,

CanFite Biopharma,

3,

CanFite Biopharma,

1;

M. Farbstein,

CanFite Biopharma,

3,

CanFite Biopharma,

1;

S. Cohen,

CanFite Biopharma,

3,

CanFite Biopharma,

1;

M. H. Silverman,

CanFite Biopharma,

3,

CanFite Biopharma,

1;

P. Fishman,

Canfite Pharma,

3,

Canfite Pharma,

1.

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