The world is fighting for COVID treatments, this is how Israel is helping
After 18 months of dedicated work by scientists and doctors around the world, promising results of new drugs to treat COVID-19 are starting to be published.
Earlier this month, U.S. company Merck announced that it had filed for emergency use authorization with the U.S. Food and Drug Administration for its oral antiviral drug Molnupiravir.
The drug, when given within the first five days of virus onset, has been shown to be effective in treating mild to moderate COVID-19 in adults who are at risk of progressing to serious illness and possible hospitalization.
Merck has submitted Phase III trial data that has been conducted in dozens of clinics around the world. It showed that molnupiravir reduced the risk of hospitalization or death by about 50%.
The first patient to receive Molnupiravir during his phase II trial was in Israel at Hadassah University Medical Center, under the supervision of Professor Yossi Caraco.
“At first, everyone focused on really sick patients,” Caraco recalls. “I thought that the approach of [targeting] moderate patients would be of benefit and were really eager to participate in this study. We have been chosen.
The last phase did not include Israel, Caraco said, mainly because the country had few eligible participants, as the majority of Israeli adults are vaccinated.
Just days after Merck’s announcement, a US-Israeli company also shared analysis from its Phase II / III trial of a drug targeting moderately severe patients – people receiving oxygen and suffering from pneumonia. .
RedHill Biopharma, the developer of Opaganib, has shown that its drug resulted in a statistically significant 62% reduction in mortality in COVID-19 patients compared to treatment with a placebo.
Opaganib is an oral antiviral and anti-inflammatory pill.
Patients left the hospital an average of four days earlier when they took Opaganib – a cumulative saving of 524 hospital days in the group of 251 study participants who received treatment on day 42.
More specifically, patients treated with Opaganib had a median time to discharge of 10 days compared to 14 days for the placebo group.
Finally, it also showed a statistically significant improvement in the results in terms of time to evacuate ambient air: some 77% of patients treated with Opaganib reached ambient air on day 14 compared with 63.5% for the placebo. .
A total of 475 people were included in the study. Participants were randomized in a 1: 1 ratio to receive either the drug or a placebo in addition to the standard treatment.
The company’s chief operating officer, Gilead Raday, said RedHill is already in discussions with the FDA to determine next steps, as it continues to analyze the results of the Phase II / III trial. He said the company would also appeal to the European Medicines Agency and regulatory bodies in some of the other countries included in the study, including those in South Africa and Israel, for emergency approval. .
“We are really proud to have completed this study,” Raday said.
Two other relevant announcements have also been made in the past month or so, the first by Todos Medical, a medical diagnostics company located in Rehovot and New York.
The company announced in mid-September that it had received a notice of clearance from the US Patent and Trademark Office for a trademark covering its oral antiviral drug known as Tollovir.
The company successfully completed a Phase I trial in 2020 evaluating the safety and efficacy of Tollovir in collaboration with NLC Pharma Israel. Todos and NLC are recruiting patients in a phase II inpatient clinical study in Israel and finalizing details of a phase II / III inpatient and outpatient study that should be ready soon.
Tollovir aims to inhibit 3CL protease, the main protease found in coronaviruses and their fundamental reproductive mechanism.
“As we continue our efforts to complete ongoing clinical studies in Israel and launch pivotal studies in India, we are also focusing on the US FDA’s commitment to evaluate Tollovir potentially as part of the pathway. emergency use authorization, ”said the president of Todos Medical. and CEO Gerald Commissiong said.
He added that the results of the first clinical trial are about to be published.
Finally, the Israel Patent Office issued a new patent earlier this month covering the immunotherapy drug Allocetra, an brainchild of Dr Dror Mevorach of Hadassah, which is being developed by the clinical stage company Enlivex Therapeutics.
Allocetra is intended to treat a wide range of cases in which there is an overreaction of the immune system, which leads to increased secretion of proteins by cells of the immune system called cytokines and causes a cytokine storm. As such, in addition to its use against COVID-19, it has been successfully tested on patients with sepsis and bone marrow transplants.
A cytokine storm occurs when the immune system goes into overdrive and begins attacking healthy cells.
Enlivex is currently conducting two parallel controlled studies of Allocetra in the treatment of COVID-19 and septic patients.
“One of the best things that we are seeing is that we have been able to drastically reduce the time in the hospital for these patients,” Mevorach told the To post earlier this year, shortly after a handful of COVID-19 patients received the experimental treatment in a first trial. “We could drastically reduce the burden on Israeli hospitals and those in other countries. “