Hospital seeks emergency approval of Israeli COVID drug for moderate-seriously ill

In letter to Health Ministry director, Ziv Medical Center points to promising results from Amor 18’s clinical trial, where all patients who received drug went on to recover

Medical workers operate in the coronavirus ward of Ziv Medical Center on September 22, 2021. (David Cohen/Flash90)
Medical workers operate in the coronavirus ward of Ziv Medical Center on September 22, 2021. (David Cohen/Flash90)

Safed’s Ziv Medical Center has sent a letter to Health Ministry director Nachman Ash requesting he grant emergency authorization for the anti-COVID drug Amor 18 developed by the Israeli company Amorphical in order to treat patients in moderate to serious condition due to the coronavirus, Channel 2 reported Friday.

Israeli biotech company Amorphical recently published what it says are promising results from the second stage of its Amor 18 clinical study.

In the first stage conducted at Ziv, Be’er Yaakov’s Assaf Harofeh and Tel Aviv’s Ichilov Hospital all patients who received the drug, which is either inhaled or taken under the tongue, went on to recover from COVID-19 and were released from the hospital

In the second phase of the trial, Ziv Medical Center recruited 37 patients in moderate-to-severe conditions to participate. Eighteen of them were given Amor 18 and 19 received a placebo.

All the patients who received Amor 18 recovered and were discharged several days later. Of the 19 others, six of them saw their condition deteriorate and had to be transferred to the ICU. Two of those patients died.

Dr. Nashat Abu Saleh, who heads the geriatrics department at Ziv Medical Center told Ash in the letter that two patients in critical condition who didn’t qualify for the trial were also given Amor 18 through compassionate use. Both of them saw their subsequent conditions significantly improve and were later released from the hospital.

Hospital staff wearing safety gear as they work in the coronavirus ward of Ziv Medical Center in the northern Israeli city of Tzfat on February 4, 2021. (David Cohen/Flash90)

If granted, the emergency authorization would be rather rare as Israeli health authorities typically rely on the US Food and Drug Administration approvals for such drugs.

But doctors at Ziv were confident that Amor 18 warranted a special, fast-tracked Israeli approval.

“In light of the unequivocal results in terms of safety and efficacy, and in light of the spread of the fifth wave — we would be grateful to receive an emergency permit to administer the drug to all coronavirus patients who are hospitalized with us,” Abu Saleh wrote to Ash.

The Amor 18 trial is expected to expand soon to medical centers in the United States and Europe and is awaiting approval from the Brazilian Drug Administration (ANVISA).

Israel began distributing the first coronavirus pills to at-risk patients with COVID-19 on January 3, several days after The first shipment of Pfizer Paxlovid pills landed at Ben Gurion Airport.

Airport workers unload packages of Pfizer’s COVID-fighting Paxlovid pill at Ben Gurion International Airport on December 30, 2021. (Avshalom Sassoni/Flash90)

Paxlovid is designed for at-home treatment of high-risk COVID-infected patients over the age of 12. Pfizer told the FDA that in a 2,250-patient trial, the pill cut hospitalizations and deaths by 89 percent when given to people with mild-to-moderate COVID-19 within three days of symptoms. Less than 1% of patients taking the drug were hospitalized and none died at the end of the 30-day study period, compared with 6.5% of patients hospitalized in the group getting a placebo pill, which included nine deaths.

Paxlovid has only proven effective if given within five days of symptoms appearing. The treatment consists of three pills taken twice a day for five days. Two of the pills are Paxlovid and the third is a different antiviral that helps boost levels of the main drug in the body.

Channel 12 reported earlier this week that about 1,000 people have started taking the pill. But some 400 people have refused to take it, despite being eligible.

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