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RedHill (RDHL) Closes Enrollment for Phase II Coronavirus Study

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RedHill Biopharma Ltd. (RDHL - Free Report) announced that it has completed enrollment in the phase II study on opaganib (Yeliva, ABC294640) in patients hospitalized with severe COVID-19 pneumonia. Top-line data from the study areexpected in the coming weeks.

A parallel global phase II/III study on orally administered opaganib for severe COVID-19 is about 50% enrolled and on track to enroll all 270 patients.Top-line data are expected in the first quarter of 2021. The study is focused on efficacy evaluation. 

The company is compiling a robust data set to support the planned emergency use applications, expected as early as the next quarter. Opaganib has a unique dual anti-inflammatory and antiviral activity, which acts on the cause and effect of the COVID-19 disease with host cell targeting. This helps in minimizing thepotential for resistance due to viral mutations.

Shares of the company have soared 32.4% so far this year against the industry’s decline of 3%.

Notably, opaganib is also being evaluated in a phase IIa study for treating advanced cholangiocarcinoma and in a phase II study for addressing prostate cancer.

Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is racing against time to develop treatments and vaccines for curing the contagion.

Regeneron (REGN - Free Report) initiated studies on its novel investigational antibody "cocktail" treatment REGN-COV2, which is designed to prevent and treat the SARS-CoV-2 virus. The company released first data in September 2020, which showed that REGN-COV2 reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in reducing medical visits.

Pharma giant Eli Lilly (LLY - Free Report) is also making painstaking efforts to develop several potential neutralizing antibodies for the treatment of COVID-19. In November 2020, Lilly’s antibody therapy was granted an emergency use authorization by the FDA for treating Covid-19, widening access to a treatment that early data suggest is effective in keeping people infected with coronavirus out of the hospital. Meanwhile, in October, Vir Biotechnology, Inc. (VIR - Free Report) and GlaxoSmithKline plc. announced the global expansion to phase III of the COMET-ICE study evaluating investigational monoclonal antibody, VIR-7831, for the early treatment of COVID-19 in patients who are at high risk of hospitalization.

Zacks Rank

RedHill currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

 

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