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In pursuit of emergency authorization
September 2020
by Lori Lesko  |  Email the author
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TEL-AVIV, Israel & RALEIGH, N.C.—Counting on investigational new drug opaganib to crush the coronavirus pandemic, specialty biopharmaceutical RedHill Biopharma Ltd. has initiated a Phase 2/3 clinical study in Brazil and Mexico and enrolled 270 subjects in a Phase 2/3 study in up to 40 clinical sites globally. In addition, in August, the company signed up 40 patients in a parallel U.S. Phase 2 study in severe COVID-19 patients.
 
“We expect to make rapid progress in enrollment, given the upsurge in new COVID-19 cases and our global outreach of up to approximately 40 sites,” says Gilead Raday, CEO of RedHill.
 
When word came down of a highly contagious coronavirus spreading rapidly from country to country, Raday wasted no time.
 
“As soon as it became clear there were three key elements to severe COVID-19 related disease and symptomology—viral, inflammatory and pulmonary—we knew we had to look more closely at opaganib as a potential novel therapy,” Raday tells DDN.
Opaganib is a proprietary, first-in-class SK2 antagonist with known anti-viral and anti-inflammatory properties that could potentially impact the devastating pulmonary effects of severe COVID-19 infection, according to Raday.
 
“Because of all the previous clinical and preclinical work we have done with opaganib—especially in previous epidemics, such as Ebola—and the fact that from a safety perspective we already had data from more than 140 patients, we were able to move very quickly in devising a developmental path forward for evaluating opaganib in severe COVID-19 patients, the first step of which we announced April 6 of this year,” he explains.
 
“Opaganib is a highly promising Phase 2/3 stage orally administered, novel therapeutic candidate for treating COVID-19 patients,” Raday adds. “On top of the unique mechanism of action combining antiviral and anti-inflammatory properties, there is promising clinical data from compassionate use.”
 
A recent published report on a RedHill study showed that hospitalized patients with severe COVID-19 treated with opaganib were all released from the hospital on room air (i.e. fully recovered), while one-third of matched case-controls from the same hospital progressed to require mechanical ventilation, he points out. This critically important clinical outcome benefit was also accompanied by faster and stronger improvements in inflammatory and disease markers in patients treated with opaganib.
 
All patients in the opaganib-treated group were discharged from hospital without requiring mechanical ventilation, whereas 33 percent of the matched case-control group required mechanical ventilation, according to the study. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.
 
Raday tells DDN that RedHill is focused on advancing its clinical program to support emergency use authorization of opaganib in severe COVID-19 patients, and notes that the primary endpoint of the Phase 2/3 study will evaluate what proportion of patients who are treated with opaganib require mechanical ventilation as compared to those who are not treated. He adds that, “We are aiming to have data from the completed studies and file global emergency use authorizations before the end of the year. Patient initiation, treatment and follow-up takes more than six weeks to complete.”
 
Emergency use authorization is granted on the basis of evidence supporting a benefit to patients. As an example, Remdesivir (an anti-viral IV drug) was granted emergency use authorization to be administered to hospitalized patients with severe disease.
 
“Our first and key objective for opaganib is to rigorously and rapidly obtain the data we need to be able to help patients across the world with severe COVID-19 infection,” Raday says. “Our intention, if the studies succeed, is to seek emergency use authorization in multiple territories (U.S., Europe and others) and make opaganib tablets available to patients in need.
 
“We are already preparing the ground for scaling up manufacturing of opaganib to support global distribution,” he continues. “In parallel to this, we continue to progress our Phase 2 development program for opaganib in bile-duct cancer and other oncology indications.”
 
Code: E082017

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