Raleigh pharma company seeks clinical study after COVID-19 treatment shows early promise
A Raleigh biotech company said Monday that it is submitting an application to the Food and Drug Administration for a U.S.-based clinical study, after its experimental COVID-19 treatment showed some positive results in a small sample of Israeli patients.
RedHill Biopharma, a publicly traded biotech company, said the Israel-based study of its treatment, opaganib, was encouraging enough to pursue randomized and placebo-controlled study in U.S. patients with the coronavirus. However, the study did not have a control group for comparison.
In the Israeli study, six COVID-19 patients who received the orally administered anti-viral drug demonstrated “significant measurable clinical improvement” in the days following treatment, including decreased lung inflammation and need for oxygen.
RedHill said five of the six patients studied were weaned from oxygen, and three were discharged from the hospital within days of the start of treatment. The sixth patient, the company added, only recently received the treatment but is improving.
Only two patients have completed 14 days of opaganib therapy.
All of the patients given opaganib were hospitalized from COVID-19 and on supplemental oxygen. RedHill noted that the patients were also being treated with other drugs, including hydroxychloroquine, a drug that is commonly used as a treatment for malaria and lupus.
“These preliminary findings are highly encouraging,,” Dr. Mark L. Levitt, RedHill’s medical director, said in a statement. “We have submitted to the FDA an application to initiate a clinical study with opaganib in the U.S. and are also working on expanding access to opaganib through compassionate use and clinical programs in additional countries.”
The company said it has submitted an Investigational New Drug (IND) application to the FDA to study opaganib in COVID-19 and pneumonia patients in the U.S. The company is also testing the drug on patients in Italy, The Triangle Business Journal reported.
In a phone interview from Tel Aviv, Israel, Gilead Raday, the company’s chief operating officer, said that while the study of Israeli patients was small, the application to the FDA is also based on more extensive pre-clinical data and safety data from previous trials of the drug as a treatment for cholangiocarcinoma, a cancer that affects the bile ducts between the gallbladder and liver.
Receiving clearance for a U.S. study “will be an important milestone” for RedHill, Raday said. He noted the company is looking for similar approvals in Europe and elsewhere.
RedHill’s stock price was up 14.7% to $8.72 per share at noon on Monday. Over the last month, the company’s stock has surged, increasing in value by 102%.
RedHill, an Israeli company whose U.S. operations are based in Raleigh, has 128 employees in the U.S., according to its filing with the Securities and Exchange Commission.
As companies race to find treatments for COVID-19, many of them have looked to see if they could re-purpose already existing treatments for the coronavirus. Opaganib was originally designed as a cancer treatment.
One promising treatment, Gilead Science’s remdesivir, posted disappointing results in a highly watched clinical trial last week, STAT news reported.
“I think it is fair to say that there is not yet a proven beneficial therapy out there,” Raday said of the quest for a COVID-19 treatment. “Some of drugs had a lead start and more advanced in the development, such a remdesivir, but the jury is still out about what is beneficial for patients.”
BioCryst, a Durham-based biotech company, is studying the effectiveness of its yellow fever drug, galidesivir, in patients in Brazil.
And several other companies and researchers in the Triangle have moved quickly to develop treatments for the coronavirus.
Scientists at UNC-Chapel Hill said earlier this month they had developed an antiviral drug for COVID-19 and are moving into human clinical trials.
Duke University is participating in a clinical trial for another COVID-19-fighting drug. Duke patients with significant symptoms of COVID-19 will be given the option to participate in the trial for the treatment, an antiviral called remdesivir.
And the Spanish biotech firm Grifols, is using its large Clayton facility to process blood from recovered COVID-19 patients in an effort to harvest coronavirus-fighting antibodies. The hope is that Grifols can use these antibodies to develop treatments for COVID-19 patients.
This story was produced with financial support from a coalition of partners led by Innovate Raleigh as part of an independent journalism fellowship program. The N&O maintains full editorial control of the work. Learn more; go to bit.ly/newsinnovate
This story was originally published April 27, 2020 at 4:15 PM.
