An SK2 Inhibitor called Opaganib Approved for Compassionate Use in Italian Severe COVID-19 ARDS

Apr 9, 2020 | Antiviral, Coronavirus, COVID-19, RedHill Biopharma, sphingosine kinase-2 (SK2) inhibitor

An SK2 Inhibitor called Opaganib Approved for Compassionate Use in Italian Severe COVID-19 ARDS

An investigational drug known as opaganib has been approved for compassionate use in small number of COVID-19 cases in Italy. The Italian National Institute for Infectious Diseases and the Central Italian Ethics Committee authorized the expanded access authorization, hence opening the door to test the effectiveness of the therapy made by an Israeli venture called RedHill BIiopharma, with its U.S.-based operation housed in North Carolina’s Research Triangle Park (RTP).

What follows is a breakdown for the TrialSite Network.

What is opaganib?

An investigational drug, opaganib is a new, first-in-class, orally administered, sphingosine kinase-2 (SK2) inhibitor with anti-viral, anti-inflammatory and anticancer characteristics. The drug was originally developed by an American-based company called Apogee Biotechnology Corp. The drug targets oncology, inflammatory, and gastrointestinal disorders.  The sponsor behind the drug, RedHill, articulates the potential to reduce lung inflammation and also lessen lung damage.

RedHill acquired the drug in 2015

The company reports that pre-clinical data reveals “unique anti-viral activity in a number of other viruses as well as anti-inflammatory activities and potential to reduce lung damage” reported Mark L. Levitt, MD, PhD, Medical Director for RedHill.

Clinical Trial Use to Date?

The drug has been tested on 131 subjects in the United States as part of a Phase I and Phase II oncology trials. Thus far, reports Mark Levitt, the clinical data has demonstrated an acceptable safety and tolerability in both healthy volunteers and cancer patients.

What is the Experimental Use Case in Italy?

Physicians in three major northern Italian hospitals, the current European epicenter, will use opaganib to treat approximately 160 COVID-19 patients who have life-threatening symptoms. Specifically, the doctors will be treating patients at high risk of developing pneumonia as well as those with pneumonia, including acute respiratory distress syndrome which of course is associated with SARS-CoV-2 as well as a higher mortality rate.

Israel Activity

The Israeli Ministry of Health allowed the use of opaganib under compassionate use guidelines recently; allowing the company to provide opaganib to a leading hospital there to treat a patient with severe COVID-19 respiratory problems. More patients in that country will be treated soon.

Who is RedHill Biopharma?

With two approved gastrointestinal products, RedHill Biopharma is publicly traded on NASAQ (RDHL). The company has six drugs in the clinical pipeline. Founded in 2009 in Tel Aviv, they opened up a U.S. headquarters office in Raleigh, NC in 2017. Raleigh is in the famous life sciences cluster called Research Triangle Park or RTP. The company has about 160 employees in its U.S. operations, about 40 of who are based in the headquarters. The company inked a deal with Cosmo Pharmaceuticals to become its supplier in Europe

Business & Finance

Like many biotech startups, its finances are somewhat precarious, although it’s impressive that they have actually secured market authorization for two products. At a share price of $6.27, their market capitalization equals $215 million. However, they forecast losses of $42 million on $6.29 revenue. With $47 million cash in hand, they report repeated losses. See financial disclosures. Its leadership can be viewed here


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