RedHill Biopharma Secures FDA OK to Commence U.S.-based Phase IIa Clinical Trial using SK2 Inhibitor on COVID-19 Patients

May 9, 2020 | Clinical Study, COVID-19, RedHill Biopharma, SK2 inhibitor

RedHill Biopharma Secures FDA OK to Commence U.S.-based Phase IIa Clinical Trial using SK2 Inhibitor on COVID-19 Patients

RedHill Biopharma received U.S. Food and Drug Administration approval to test opaganib, a investigational drug in the United States. The company, headquartered in Israel with a commercial office in Raleigh, North Carolina, received the greenlight from the agency to commence a Phase II clinical trial using opaganib.

Existing Research

To date, 139 patients have been dosed with opaganib in ongoing and completed Phase I and Phase II clinical trials in oncology indications and in pharmacokinetic studies in healthy volunteers in the U.S., reports the sponsor. Other dosed patients come from existing FDA-approved expanded access requests from physicians for individual oncology patients and under expanded access for COVID-19 patients in Israel, establishing safety and tolerability in humans both in the US and abroad.

Findings in Israel Under Compassionate Use

Preliminary findings from six moderate-to-severe COVID-19 patients treated with opaganib in Israel under compassionate use have shown that all the patients demonstrated both subjective and objective significant measurable clinical improvement within days following treatment initiation with opaganib, including decreased required supplemental oxygenation, higher lymphocyte counts and decreased C-reactive protein (CRP) levels. All six patients analyzed were weaned from oxygen and discharged from the hospital. Opaganib has been well tolerated and showed clinical improvement both with and without hydroxychloroquine. At the time of treatment initiation, all of the patients were hospitalized, suffered from moderate-to-severe acute respiratory symptoms related to SARS-CoV-2 infection, were hypoxic, and required supplemental oxygen while being treated with standard-of-care, mostly hydroxychloroquine.

The Study

In this placebo-controlled study, opaganib will be administered to up to 40 hospitalized patients with moderate to severe SARS-CoV-2 and pneumonia—the patients must also be on supplemental oxygen. Half of the patients will receive the experimental therapy and half will receive the placebo. The sponsor’s primary endpoint: measurable lung improvement for up to 14 days in addition to reduction in fever and a negative nasal swab test for the virus at day number 14.

The Drug

TrialSite News profiled this drug that RedHill acquired in 2015. 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. Originally developed by Apogee Biotechnology Corp, the drug targets oncology, inflammatory, and gastrointestinal disorders.

Who is Redhill?

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. The company promotes the gastrointestinal drugs Movantik® for opioid-induced constipation in adults; Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® for the treatment of travelers’ diarrhea in adults.

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 $6.90, their market capitalization equals $243.4 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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