An Israeli drugmaker says a therapy it is developing reduced deaths among patients battling serious bouts of COVID-19 by 70 percent, and nearly halved hospitalization length in a small trial.
A clinical study for MesenCure, conducted in Israel, involved 50 patients hospitalized in serious condition, and a similar size control group that received the best standard of care without the drug.
Haifa-based Bonus BioGroup, which developed the drug, reported that out of the first 30 patients who received the therapy, two died, representing 6.7% of the group, and the average hospitalization of those treated was 9.4 days. A third of the patients who received the drug were discharged from the hospital as the five-day course of treatment ended.
Among the control group, 23.3% of the patients died of COVID-19 or its complications, and average hospitalization was 17.2 days. The control group was selected algorithmically out of a pool of hundreds of patients, who were matched to test group subjects by gender, age and pre-existing conditions.
Data on the final 20 patients is still being analyzed, the company said.
“This is going to be a solution for severe COVID-19 patients because it tackles inflammation, tackles pneumonia and ameliorates the cytokine storm, the excessive immune response initiated by the coronavirus,” Dr. Tomer Bronshtein, head of research at Bonus BioGroup, told The Times of Israel.
“This drug can help hundreds of thousands of patients worldwide who despite vaccines may well suffer.”
The Phase II trial was heavily focused on safety rather than efficacy, and doctors caution that more data is needed to know if the drug works.
“This is not a scientific proof of efficacy, but a very lean statement seemingly directed at investors, but based on what we have seen it seems interesting,” Prof. Eyal Leshem, a senior infectious diseases doctor at Sheba Medical Center who is unconnected to the drug developer, told The Times of Israel.
Bonus BioGroup is planning a larger Phase III trial to prove efficacy, and is readying to apply for emergency use approval in Israel, the United States and Europe.
Bonus Biogroup developed the treatment using mesenchymal stromal cells, which are human cells isolated from bone marrow, adipose and other tissue sources. The company says that the cells reduce inflammation and alleviate respiratory symptoms. It derives cells from the adipose tissue and produces 45,000 doses — enough to treat 15,000 people — from a single donor.
“In treating severe COVID-19 with MesenCure, instead of sending in a single drug that acts on one target, we are sending in a living cell,” Bronshtein said. “It can sense the environment and tune the body’s response accordingly to achieve optimal outcomes by vending the right amounts of different biologically active molecules to counteract inflammation.”