Israeli treatment for severe COVID-19 reduced mortality by 70% in Phase 2 trial

An Israeli biotechnology company detected in a Phase II clinical trial that an injectable drug that is being developed against COVID-19 is capable of reducing mortality by 70%. The study was conducted in three hospitals in Israel, in a group of patients with grave pictures by coronavirus and showed that high recovery rate.

The company Bonus BioGroup released new data this week showing that the 30-day survival rate of 50 critically ill hospitalized patients with oxygen saturation of 93% or less and diffuse pneumoniawho received up to three doses of the treatment MesenCure was 94%, that is, 47 out of 50 patients survived.

When comparing the first 30 patients in the trial with 60 similar patients who were used as a control group, the result is even more surprising: Only 6.7% of patients treated with MesenCure died of COVID-19 or its complications, compared to 23.3%. of the control group.

“The results are better than we expected,” said the doctor. Shai Meretzki, CEO of the company. “We expected good results, but not so good results compared to the control group.”

The vaccine can be used to prevent coronavirus. The new drugs from Merck and Pfizer they are showing a probability of success in treating mild patients, with risk factors, in the early stages of the disease. But there is still no drug available to help save the lives of the most severe COVID-19 patients.

Pneumonia and cytokine storms that cause respiratory distress are a common complication of COVID-19, caused by excess accumulation of white blood cells and fluid in the lungs.

MesenCure is a cell therapy that consists in millions of live cells packaged and delivered with each dose. The drug consists of activated mesenchymal stromal cells (MSCs) that are isolated from adipose tissue of healthy donors; A minimum of 45,000 doses can be produced from a single lipoaspirate donor after cell expansion and enhancement.

The cells are infused into a sick person, and in the infusion, the living cells travel through the bloodstream to the lungs. When they detect inflammation, the cells of the drug begin to secrete anti-inflammatory and regenerative factors.

These factors reduce inflammatory cell activation and cytokine storm and prevent inflammatory cells from building up further in the lungs. They also promote the clearance of white blood cells and support tissue regeneration.

About a third of patients who were discharged the day treatment ended.

Once the inflammation has been relieved and excess fluid has been removed from the lungs, respiratory distress improves.

The Phase II trial included 50 patients, all defined as severe. Most of them also had some underlying medical condition that would make them more likely to die from COVID-19, and diabetes, obesity, excess lipids in the blood or hypertension, explained the doctor Tomer Bronshtein, Head of Research at Bonus BioGroup.

The patients had between 41 and 77 years of age. Each one was matched with two critically ill patients with similar characteristics of sex, age and comorbidities who met the inclusion criteria of the clinical trial although they only received the best standard of care according to their condition and not MesenCure.

The trial took place in medical centers Rambam Health Care Campus, Kaplan Medical Center and Baruch Padeh Medical Center.

Beyond the mortality results, it was also found that MesenCure shortens the hospitalization period for treated patients by 45% from an average of 17.2 days to just 9.4 days, a difference of 8 days.

Approximately half of the critically ill patients treated with MesenCure were discharged from the hospital until just one day after the end of treatment, more than a third of the patients were discharged from the hospital the day their treatment ended, and more than 60 % of them were discharged up to two days after treatment.

Bronshtein said that about a third of the patients who were discharged the day treatment ended could have been discharged even before receiving the third and final dose, but simply stayed in the hospital to complete the trial.

This means, he explained, that under real-world conditions, the reduction in hospitalization days is likely to be even greater.

“By freeing up intensive care unit beds, physicians will be able to provide better care for other patients,” Bronshtein said.

He added that the first patient to be given MesenCure, a 73 year old woman, recovered so quickly after receiving only one dose of the treatment that doctors called the company to report that she was out of bed and working out the next day.

“This was a very encouraging start for us,” the doctor mentioned, adding that accelerated healing will likely mean a lower risk of developing prolonged COVID-19 and other disabilities related to that disease.

Based on these results, Meretzki said that he hopes that soon Bonus BioGroup can treat many more patients not only in Israel but in other parts of the world. He assured that the company is preparing the data for submission to regulators in the United States and Europe.

“We hope to have results now that are good enough for emergency approval,” Meretzki said. The data is also now being prepared for peer review by a major scientific journal.

The Israeli Ministry of Health has already received the data and it has been reviewed by a board of external experts at the request of the specialists involved in the trial. “People are dying,” Meretzki said. “We believe that we can save the lives of most of them.”

In October, MSD, an American biopharmaceutical company known in the United States and Canada as Merck & Co. and Ridgerback Biotherapeutics, a Miami-based biotech company that had previously developed a monoclonal antibody to Ebola, announced that molnupiravir, a brand-new pill against COVID-19, could cut in half the chances that a person infected with the coronavirus should be hospitalized.

Recently European Union approved MSD’s COVID-19 pill and evaluates Pfizer’s.

Meretzki said he is hopeful that soon Bonus BioGroup will be able to treat many more patients not only in Israel but in other parts of the world.

The drug was so effective that an independent committee asked the scientists to quickly halt the Phase III trialas it was unethical to continue giving placebo to half of the participants, when none of the around 400 people who received the oral pill died and the drug was not shown to have any major side effects.

On November 4, the United Kingdom became the first country to approve molnupiravir. In turn, the US Food and Drug Administration (FDA) is expected to obtain an authorization for its emergency use in December.

The other great hopeful development to defeat this pandemic is Pfizer’s new COVID-19 pills.

Pharmaceutical Pfizer announced earlier this month that its COVID-19 pill, Paxlovid, used in combination with a widely used anti-HIV medicine, reduces the risk of hospitalization or death by 89% in high-risk adults who have been exposed to the virus.

The pill must be taken twice a day for five days and is used in combination with a second medicine called ritonavir which helps the Paxlovid compound to stay in the bloodstream longer.

Consulted by Infobae, Laura Palermo, doctor in virology, specialist in the history of diseases and professor at Hunter College in New York, highlighted: “Beyond the vaccines that were developed to prevent the coronavirus, the new antiviral pills are the best pharmacological tools to fight this virus“.

Currently, treatments aimed at fighting viruses, mainly monoclonal antibodies and antiviral drugs such as Remdesivir, are administered by infusion or injection, generally in clinics or hospitals, and are characterized by their high cost.