Experimental RedHill COVID-19 Drug Logs Positive Results

RedHill Biopharma is reporting positive early results from one of its potential treatments for COVID-19.

The Israeli company, which has its U.S. headquarters and commercial operations in Raleigh, says five Israeli patients hospitalized with severe COVID-19 infections showed substantial benefit from its novel drug, opaganib​ (Yeliva, ABC294640). RedHill published the results, entitled “Compassionate Use of Opaganib For Patients with Severe COVID-19,” under an expedited process making them available publicly  in medRxiv.

“We are very encouraged by the analysis from severe COVID-19 patients treated with opaganib to date, demonstrating substantial benefit to patients in both clinical outcomes and inflammatory markers as compared to a matched case-control group,” said Mark. Levitt, M.D., Ph.D., medical director at RedHill.

“This data further supports our intensive efforts to rapidly advance the development of opaganib via the recently initiated Phase 2a clinical study under IND with the FDA and the Phase 2/3 study in European and other countries which we expect to initiate shortly, as well as through ongoing and planned compassionate use programs.”

Opaganib is a new first-in-class orally administered sphingosine kinase-2 (SK2) inhibitor with anti-viral, anti-inflammatory and anticancer characteristics, according to RedHill. Originally developed by U.S.-based Apogee Biotechnology Corp., the drug targets oncology, inflammatory and gastrointestinal disorders. RedHill determined that the therapy also has the potential to reduce lung inflammation and damage.

Under a compassionate use program for COVID-19 patients in Israel, patients treated with opaganib showed improvement in both clinical outcomes and inflammatory markers as compared to a matched case-control group from the same hospital.

All patients in the opaganib-treated group were discharged from the hospital without requiring mechanical ventilation, whereas 33% of the matched case-control group required mechanical ventilation. 

Median time to weaning from high-flow nasal cannulas was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group. 

RedHill has now submitted Phase 2/3 Clinical Trial Applications for a randomized, double-blind, parallel-arm, placebo-controlled study with opaganib in 270 patients with severe COVID-19 in up to 40 sites across Russia, Italy, the UK and other countries.

Meanwhile, it has submitted an Investigational New Drug application to the U.S. Food and Drug Administration to evaluate opaganib in a clinical study in adults diagnosed with COVID-19 and pneumonia.

RedHill also has another investigational drug, RHB-107 (upamostat, WX-671), approved for testing in non-clinical studies against the novel coronavirus.

It’s part of an agreement with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

RHB-107 is a proprietary, first-in-class orally administered protease inhibitor targeting pancreatic cancer and inflammatory gastrointestinal diseases. According to RedHill, it presents a new, non-cytotoxic approach to cancer therapy.

The drug has already been studied in more than 300 people across 10 clinical studies, including two completed Phase 2 studies in oncology patients and several Phase 1 studies in healthy volunteers and oncology patients. RedHill said these studies helped establish the safety and tolerability of RHB-107 in humans.

It’s now being used for in vitro testing against COVID-19, which, if successful, could lead to testing in humans for treating COVID-19.