Can-Fite BioPharma Ltd. (TASE: CFBI), (NYSE MKT: CANF), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced results from a 12-week, placebo-controlled Phase IIb study involving 79 patients with active rheumatoid arthritis ("RA") for its proprietary drug CF101, an A3 adenosine receptor ("A3AR") agonist. The study entailed 2 arms, a placebo and a CF101 1 mg treated group, in which CF101 was administered orally twice-daily as a monotherapy for 12 weeks to patients with RA. Only patients with elevated baseline expression levels of the biomarker A3AR were enrolled in the study.
In the study, CF101 1 mg met all primary efficacy endpoints, showing statistically significant superiority over placebo in reducing signs and symptoms of RA as compared to the placebo, as measured by ACR20 response rates at 12 weeks (ACR20 response rates: placebo = 25%; CF101 = 49%,s observations in the previously reported CF101 psoriasis trials, the response of patients with RA was cumulative over time, suggesting a consistent anti-inflammatory effect of CF101. Moreover, half of the RA patients treated with CF101 showed clinically meaningful improvement.
CF101 was very well-tolerated with no evidence of immunosuppression. CF101 had an excellent safety profile, as has already been shown in more than 750 patients in previously reported Phase II clinical studies in autoimmune and inflammatory diseases. Additionally, all treatment-emergent adverse events were mild to moderate in intensity.