15th Oct，2019 — Can-Fite BioPharma Ltd. issued an announcement, which is summarized as follows:
Can-Fite BioPharma Ltd. announced today it has completed patient enrollment in its Phase II study of Namodenoson in the treatment of NAFLD/NASH.
The multicenter, randomized, double-blinded, placebo-controlled, dose-finding efficacy and safety study has enrolled 60 patients with NAFLD (non-alcoholic fatty liver disease) with or without NASH (non-alcoholic steatohepatitis). Patients who suffer from NAFLD/NASH with evidence of active inflammation are treated twice daily with 12.5 mg or 25 mg of oral Namodenoson, or placebo for 12 weeks. The primary endpoint of the Phase II study is the anti-inflammatory effect of the drug, as determined by mean percent change from baseline in ALT blood levels and safety. Secondary endpoints include percentage change from baseline of liver fat, as measured by MRI-PDFF (proton density fat fraction).
“We look forward to completing the treatment regimen for our last patients in this Phase II study and to reporting our topline results in the first quarter of 2020. If the study achieves its primary endpoint, we expect to advance it towards a Phase III trial in NASH,” stated Can-Fite CEO Dr. Pnina Fishman.
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