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Wednesday, July 22, 2020

=RedHill Biopharma (RDHL) Accelerates Phase 2/3 COVID-19 Program with Addition of Brazil and Mexico

RedHill Biopharma adds Mexico and Brazil to Phase 2/3 clinical study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia
  • The co submitted a Clinical Trial Application (CTA) with the Mexican Federal Committee for the Protection against Sanitary Risks (COFEPRIS) and initiated CTA submission with the Brazilian Health Regulatory Agency.
  • Phase 2/3 study process initiated in Brazil and Mexico.
  • The global Phase 2/3 study with opaganib in patients with severe COVID-19 has already been approved in the UK and Russia.
  • Enrollment planned to be initiated this month - 270 subjects to be enrolled in up to 40 clinical sites.
  • Potential submission of emergency use applications planned for Q4/2020.
  • Enrollment in parallel U.S. Phase 2 study in severe COVID-19 patients expected to be completed in August.

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