COVID-19 - Yeliva (opaganib)
Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)
Opaganib - COVID-19 - RedHill is working to develop opaganib (Yeliva, ACB294640) for COVID-19. Opaganib has a unique mechanism of action, with both anti-inflammatory and anti-viral activity, targeting a critical host factor, which minimizes the potential development of resistance due to viral mutations. RedHill is advancing a development program evaluating opaganib as a therapy for patients with severe COVID-19 infection, which includes two ongoing clinical studies:
- A global randomized, double-blind, parallel-arm, placebo-controlled global Phase 2/3 study (NCT04467840)
- A U.S. randomized, double-blind, placebo-controlled Phase 2 study (NCT04414618)
RedHill Biopharma’s Phase 2/3 COVID-19 Study Approved in Mexico - The global Phase 2/3 study with opaganib is set to enroll up to 270 patients with severe COVID-19 across 40 clinical site. The global Phase 2/3 study has been approved in Mexico, the UK and Russia and is also under review in Italy, Brazil and additional countries. Enrollment in a parallel U.S. Phase 2 study in patients with severe COVID-19 is approximately 50% complete and is expected to be completed this month. Potential submission of global emergency use applications planned as early as Q4/2020.
RedHill Biopharma Announces Approval of Compassionate Use of Opaganib for COVID-19 in Italy
RedHill Announces First COVID-19 Patient Treated with Opaganib in Israel Under Compassionate Use