RedHill Gets Nod in Brazil for Coronavirus Study on Opaganib

RedHill Biopharma Ltd. RDHL announced that the Brazilian Health Regulatory Agency (ANVISA) has approved the ongoing phase II/III study on its novel investigational candidate opaganib, also called Yeliva. The company is looking to evaluate opaganib in patients hospitalized with severe COVID-19 infection and pneumonia in Brazil.

Shares of RedHill were up 2.4% following the aforementioned news on Tuesday. In fact, the stock has soared 72.3% so far this year against the industry’s decline of 7.6%.

This global phase II/III study is looking to enroll 270 patients with severe COVID-19 pneumonia who require hospitalization and treatment with supplemental oxygenation. The study is currently underway in Israel, the United Kingdom, Italy, Russia and Mexico and will soon begin in Brazil.

Notably, RedHill’s phase II study on opaganib for addressing severe COVID-19 patients in the United States already finished enrolling approximately 75% patients with the rest expected to be completed in the coming weeks. The company is rapidly progressing the study in the United States and other countries globally, after preclinical data on opaganib demonstrated its ability to stop SARS-CoV-2 viral replication in its tracks and prevented the spread of the disease, which causes damage to other cells.

The company plans to submit global emergency use authorization applications for opaganib if data from the clinical studies is found positive.

Importantly, opaganib completely inhibited SARS-CoV-2 viral replication in vitro human lung cell model, comparing favorably with Gilead’s Veklury (remdesivir). The FDA issued an Emergency Use Authorization (EUA) for Veklury to treat hospitalized patients with severe COVID-19 in May 2020.

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 initiated studies on its novel investigational antibody "cocktail" treatment REGN-COV2, which is designed to prevent and treat the SARS-CoV-2 virus.

Pharma giant Eli Lilly LLY is also making painstaking efforts to develop several potential neutralizing antibodies for the treatment of COVID-19. Meanwhile, Vir Biotechnology’s VIR investigational monoclonal antibody VIR-7831 entered the phase II/III study in August for the early treatment of COVID-19 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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