Back to top

Image: Bigstock

RedHill (RDHL) to Begin Study on Second Coronavirus Candidate

Read MoreHide Full Article

RedHill Biopharma Ltd. (RDHL - Free Report) announced that the FDA has cleared the investigational new drug (IND) application to begin a phase II/III study on its second coronavirus candidate RHB-107 for addressing patients with symptomatic COVID-19 who do not require hospitalization. Enrollment in the study is expected to begin early next year.

The double-blind phase II/III study will enroll patients with symptomatic diagnostically confirmed COVID-19 infection who do not require hospitalization. The primary endpoints will include the safety and tolerability of RHB-107 and also check the time to recovery from symptomatic illness versus placebo.

Notably, RHB-107, an orally administered serine protease inhibitor, demonstrated a strong inhibition of SARS-CoV-2 viral replication in a human bronchial cell model. RHB-107 is also being evaluated in several mid-stage studies for treating cancer, inflammatory lung diseases and gastrointestinal diseases.

Shares of RedHill have surged 32.4% so far this year against the industry’s decrease of 3.2%.

Price chart for RedHill


In April 2020, RedHill entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), to evaluate RHB-107 and check its activity against SARS-CoV-2, the virus that causes coronavirus disease.

We note that RHB-107 is RedHill’s second investigational drug that is being evaluated for COVID-19. The company is also evaluating its novel investigational candidate, opaganib as a potential treatment for COVID-19.

Earlier this week, RedHill completed enrollment in the phase II study investigating opaganib in patients hospitalized with severe COVID-19 pneumonia in the United States. Top-line data from the study are expected in the coming weeks.

Meanwhile, a global phase II/III study on opaganib (administered orally) for severe COVID-19 already enrolled more than 50% of the total cohort and is on track to enroll all 270 patients. Top-line data is expected in the first quarter of 2021. Per the company, data from the phase II study in the United States and the global phase II/III study will support the potential emergency use authorization application for opaganib.

We note that the pharma/biotech sector is racing against time to develop treatments and vaccines for curing the COVID-19 contagion.

Earlier this month, the FDA granted Emergency Use Authorization (EUA) to Eli Lilly’s (LLY - Free Report) antibody drug bamlanivimab (LY-CoV555) as a monotherapy for treating the recently-diagnosed mild-to-moderate COVID-19 illness in patients who are at high risk of progressing to severe COVID-19 or hospitalization.

Last month, Regeneron (REGN - Free Report) submitted a request to the FDA for an Emergency Use Authorization (EUA) for its experimental COVID-19 treatment REGN-COV2 in patients with mild-to-moderate COVID-19 who are at risk of poor outcomes. Meanwhile, Vir Biotechnology (VIR - Free Report) is evaluating its investigational monoclonal antibody VIR-7831 in a phase III study 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.

Zacks Names “Single Best Pick to Double”

From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.

You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.

Free: See Our Top Stock and 4 Runners Up >>

Published in