An Israeli Biotechnology Company Unearthed Phase II Clinical Trials that an injectable drug that is being developed against COVID-19 is capable of reducing mortality From 70%. the study was conducted in Three hospitals in Israel, in a group of patients with serious pictures by coronavirus and showed that high recovery rate.
company Bonus Biogroup released new data this week which shows that 30-day survival rate of 50 critically ill patients hospitalized with 93% or less oxygen saturation and diffuse pneumoniawho received up to three doses of treatment mesencure was 94%, that is, 47 out of 50 patients survived.
The first 30 patients in the trial are compared with 60 identical patients who were used as a control group, the result being even more surprising: Only 6.7% of patients treated with Mesencure died of COVID-19 or its complications, compared to 23.3%. of 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.”
Vaccines can be used to protect against coronavirus. Merck & Pfizer’s new drugs They are showing potential for success in treating mild patients with no risk factors, in the early stages of the disease. But there is still no medicine available to help save the lives of the most severe COVID-19 patients.
Pneumonia and cytokine storms, which cause respiratory distress, are a common complication of COVID-19, caused by an excess accumulation of white blood cells and fluid in the lungs.
Mesencure is a cell therapy consisting of Packaged in millions of live cells and delivered with each dose, The drug contains activated mesenchymal stromal cells (MSCs) isolated from the adipose tissue of healthy donors; A minimum of 45,000 doses can be produced from a single lipoaspirate donor after cell expansion and growth.
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 further build-up of inflammatory cells in the lungs. They also promote the clearance of white blood cells and support tissue regeneration.
Once the swelling is relieved and excess fluid is removed from the lungs, Shortness of breath improves.
Phase II trials include 50 patients, all defined as severe. Most of them also had some underlying medical condition that made them more likely to die of COVID-19, What diabetes, obesity, excess lipids in the blood or high blood pressure, explained to the doctor Tomar Bronshtein, Head of Research at Bonus Biogroup,
patients had Between 41 to 77 years of age. Each was matched with two critically ill patients with similar characteristics of gender, age and comorbidity who met the clinical trial’s inclusion criteria, although they only received the best standard of care according to their condition Was, not Messencure.
Testing took place in medical centers Rambam Health Care Campus, Kaplan Medical Center and Baruch Padeh Medical Center.
Beyond the mortality consequences, it was also found that Mesencure reduces the length of hospitalization for treated patients by 45%, with an average of 17.2 days to 9.4 days, a difference of 8 days.
About half of the critically ill patients treated with Mesencure were discharged from hospital the day after treatment ended, with more than a third of patients being discharged from the hospital on the day their treatment ended. and more than 60% of them were discharged after two days of treatment.
Bronshtein said that About a third of the patients, who were discharged on the day treatment ended, could have been discharged before receiving the third and final dose, but remained in the hospital to complete the test., This means, he explained, that under real-world conditions, The days of hospitalization are likely to decrease further.
“By freeing up intensive care unit beds, physicians will be able to provide better care for other patients,” Bronshtein said.
He said that the first patient to be given Mesencure, a 73 year old woman, recovered so quickly after receiving only one dose of treatment that doctors called the company to report I was out of bed and working the next day.
“It was a very encouraging start for us,” The doctor noted, that prompt treatment would mean a lower risk of developing COVID-19 and other disabilities related to that disease in the long run.
Based on these results, Meretzky said he hoped that soon Bonus Biogroup Could treat many more patients not only in Israel but in other parts of the world. He assured that the company Preparing data for submission to regulators in the United States and Europe.
“We expect there will now be results that are good enough for emergency approval,” Meretzky said. The data is also now being prepared for peer review by a leading scientific journal. The data has already been received by Israel’s health ministry and it has been reviewed by a board of outside experts at the request of the experts involved in the trial. “People are dying,” said Meretzky. “We believe we can save the lives of most of them.”
In October, msd, an American biopharmaceutical company known in the United States and Canada Merck & Co. And Ridgeback Biotherapeutics, a Miami-based biotech company that previously developed a monoclonal antibody to Ebola, announced that molnupiravir, a new pill against COVID-19, could halve the chance that a person infected with the coronavirus would need to be hospitalized., recently EU approves MSD’s COVID-19 pill and Pfizer evaluates,
The drug was so effective that an independent committee asked scientists to quickly stop Phase III trialsBecause it was unethical to continue giving placebo to half the participants, none of the nearly 400 people who took the oral pill died and the drug showed no major side effects. On 4 November, the United Kingdom became the first country to approve molanupiravir. In return, the US Food and Drug Administration (FDA) expects to receive an authorization for its emergency use in December.
The other great hopeful development is Pfizer’s new COVID-19 pills to defeat this pandemic.
Pharmaceutical Pfizer announced earlier this month that its COVID-19 pill, Paxlovid
, Used in combination with the widely used anti-HIV drug, Reduces the risk of hospitalization or death by 89% in high-risk adults who have been exposed to the virus, The pill is to be taken twice a day for five days and is used in combination with another 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 vaccines developed to prevent coronavirus, new antiviral pills are the best pharmacological tool to fight this virus“. Currently, treatments aimed at fighting the virus, mainly monoclonal antibodies and antiviral drugs such as remdesivir, are usually administered by infusion or injection in clinics or hospitals, and are characterized by their high cost.