RedHill Biopharma Ltd. RDHL announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved its Clinical Trial Authorization (CTA) application to begin a phase II/III study on its investigational candidate, opaganib, also called Yeliva. The company is looking to evaluate opaganib in patients hospitalized with severe COVID-19 infection and pneumonia in the United Kingdom.
RedHill already initiated a phase IIa study to evaluate opaganib for addressing severe COVID-19 patients in the United States.
Earlier this month, RedHill submitted CTA applications in the United Kingdom and Italy to conduct this study on opaganib. The company also filed a CTA in Russia for this study and plans to expand the same to additional countries.
Per the company, this multi-center, double-blind, placebo-controlled study is looking to enroll 270 patients across the United Kingdom, Russia, Italy and other countries with severe COVID-19 pneumonia who require hospitalization and treatment with supplemental oxygenation. The primary endpoint of the study is to check the proportion of patients requiring intubation and mechanical ventilation by day 14.
Shares of RedHill have rallied 15.6% so far this year against the industry’s decrease of 6.6%.
The COVID-19 outbreak already infected more than 10 million people and the death toll crossed 500,000 globally.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2, the virus that causes COVID-19 disease. The entire world is hoping for a rapid development of treatment/antibody to treat COVID-19 or a vaccine to prevent the disease.
Several marketed drugs like Roche’s RHHBY IL-6 inhibitor Actemra, Incyte/Novarts’ JAK1/JAK2 inhibitor Jakafi, AstraZeneca’s AZN BTK inhibitor Calquence, Amgen’s AMGN PDE4 inhibitor Otezla and Sanofi/Regeneron’s IL-6 inhibitor Kevzara among others are being evaluated to treat respiratory complications associated with COVID-19.
RedHill currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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