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Biopharmaceutical company Red Hill today announced that it has obtained approval from mexico's Federal Health Risk Protection Board (COFEPRIS) to conduct Phase II/III clinical trials of Opaganib (Yeliva®, ABC294640) for the treatment of patients with severe SARS-CoV-2 infection.
RedHill's research has now been approved in Mexico, the UK and Russia and is being reviewed in Italy, Brazil and other countries, with plans to extend it further to other countries.
, chief operating officer of Red Hill, said: "With the proliferation of infections bringing new and serious cases, drug developers must respond with rigorous design and rapidly implemented research.
Opaganib is one of the new treatments currently being tested for the treatment of severely ill COVID-19."
the multi-center, randomized, double-blind, parallel arm, placebo-controlled Phase II/III study (NCT04467840) aims to recruit up to 270 patients with severe COVID-19 pneumonia who require hospitalization and oxygen supplementation.
subjects will be randomly assigned at a 1:1 ratio to receive opaganib or placebo, as well as standard therapy.
the main endpoint of the study was to assess the proportion of patients requiring int tubes and mechanical breathing by the 14th day.
, registration for Opaganib's U.S. Phase II clinical study has been completed by about 50 percent and is expected to be completed this month.
the randomized, double-blind, placebo-controlled study (NCT04414618) aimed to recruit up to 40 patients with severe COVID-19 pneumonia who needed hospitalization and oxygen supplementation.
Opaganib is an oral steroid kinase 2 (SK2) selective inhibitor with anti-cancer, anti-inflammatory and antiviral activity for a variety of tumors, viruses, inflammatory and gastrointestinal adaptations.
by inhibiting SK2, Opaganib affects a variety of cellular pathways associated with cancer growth, viral replication, and pathological inflammation.
originally developed by Apogee Biotechnology, Opaganib has completed a number of preclinical and Phase I clinical studies involving oncology and inflammation.
, Opaganib obtained orphan drugs from the FDA for the treatment of bile tube cancer and is evaluating the effectiveness of treatment for advanced bile tube and prostate cancer.
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