Can-Fite BioPharma Ltd. (TASE:CFBI; Bulletin Board:CANFY) reports positive results in a Phase IIb trial for a rheumatoid arthritis treatment. The 12-week placebo-controlled Phase IIb study involving 79 patients with active rheumatoid arthritis (RA) for its proprietary drug CF101, an A3 adenosine receptor agonist, met all its primary efficacy endpoints.
The study encompassed a placebo and a CF101 1 mg treated group, in which CF101 was administered orally twice-daily as a mono-therapy for 12 weeks to patients with RA. Only patients with elevated baseline expression levels of the biomarker A3AR were enrolled in the study.
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The study’s results showed 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.
CF101 was very well-tolerated with no evidence of immunosuppression. CF101 has an excellent safety profile, Can-Fite said, 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.
Can-Fite is a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases.
Can-Fite CEO Pnina Fishman said, “Along with our recently presented interim analysis data with CF101 in psoriasis, results from this study in RA, in which half of the patients treated with CF101 showed clinically meaningful improvement, demonstrate the potential of the A3AR agonist CF101 in inflammatory indications. The data also supports the notion that A3AR can be used as a biological predictive marker.”