Trial Shows Anti-Inflammatory Drug Stops Covid-19 Hospitalization

Scanning electron microscope image of SARS-Cov-2 virus, responsible for Covid-19 infections (NIH.gov)

3 Jan. 2023. Findings from a clinical trial show an anti-inflammatory drug reduces new symptoms among people with Covid-19 infections and keeps them out of the hospital. Results of the trial, conducted by RedHill BioPharma Ltd. in Tel Aviv, Israel and Raleigh, North Carolina, appear in the 19 Dec. 2022 issue of the International Journal of Infectious Diseases.

RedHill BioPharma is a developer of drugs mainly for gastrointestinal disorders and infectious diseases, but has begun testing its treatments on other disorders. One of those drugs is upamostat, in a class of compounds called serine protease inhibitors, designed to block enzymes associated with inflammatory responses and blood clotting. RedHill Bio developed upamostat initially as a treatment for locally advanced non-metastatic pancreatic cancer and in metastatic breast cancer, with the drug in early- and mid-stage clinical trials.

The company is also testing upamostat as an oral antiviral treatment for people with Covid-19 infections and symptoms, but not currently hospitalized or requiring supplemental oxygen. The journal article reports on a mid-stage clinical trial of upamostat that aimed to enroll 310 non-hospitalized participants with SARS-CoV-2 infections and Covid-19 symptoms at 17 sites in the U.S. and South Africa. The RedHill Bio team divided the study in two parts, with the first part looking mainly at safety and tolerability of the drug at two dosage levels, while the second part focused on efficacy, defined as sustained recovery from Covid-19 symptoms as well as need for hospitalization.

One drug-related adverse effect

The researchers ended up enrolling only 61 participants at seven sites, but still proceeded with the trial. Some 21 participants received a 400 milligram upamostat tablet once a day for 14 days, while 20 participants received a 200 milligram tablet, and another 20 participants received a placebo. The study team then tracked participants for eight weeks, with participants reporting with smartphone-based online questionnaires, and visits to a clinic at two, four, and eight weeks.

Results show upamostat is well tolerated among participants, with only one recipient of the drug, at 400 milligrams, experiencing a mild skin rash as the only adverse effect. In addition, no recipients of upamostat at either dose discontinued taking part the trial due to a drug-related adverse effect.

The trial’s placebo recipients required a median of eight days to recover from severe Covid-19 symptoms, while upamostat recipients at 200 and 400 milligrams a day required three and four days respectively. Also, new severe symptoms appeared in 20 percent of the placebo recipients, compared to two percent of upamostat recipients. Plus, 15 percent of placebo recipients required hospitalization, compared to none of the upamostat recipients. In both cases differences are large enough for statistical reliability. Blood tests taken from participants show as well that average D-dimer levels — protein fragments associated with blood clotting, an indicator of serine inhibitor activity — declined 38 and 48 percent among 200 and 400 milligram recipients respectively, while levels remained constant for placebo recipients.

RedHill BioPharma says the results support the company’s decision to proceed with a late-stage multi-national clinical trial of upamostat, code-named RHB-107. “Showing both safety and efficacy signals,” says RedHill Bio medical director and lead author Terry Plasse in a company statement, “in a highly convenient once-daily oral therapy, positively positions investigational RHB-107 as a potentially very useful treatment for Covid-19 outpatients to reduce symptom severity and prevent disease progression and hospitalization.”

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