A new drug called Narsoplimab is showing early promise as a treatment for patients with severe COVID-19.
Narsoplimab is produced by Omeros, a pharmaceutical company headquartered in Seattle.
“The data and the scientific rationale certainly suggest that Narsoplimab is potentially one of the premiere treatments for critically ill COVID patients,” said Dr. Greg Demopulos, chairman and CEO of Omeros. “Right now, it warrants further investigation and development.”
At present, there are very few drugs to treat patients with severe COVID-19.
To understand how Narsoplimab works, it is important to understand how the coronavirus causes severe COVID-19.
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Once the coronavirus reaches the lungs, it soon infects the surrounding blood vessels. This triggers a response from part of the immune system called the “lectin pathway.” The lectin pathway releases an enzyme called MASPS-2, which causes uncontrolled inflammation in the blood vessels. This further damages the blood vessels and can lead to thrombosis, or blood clots in the arteries.
Narsoplimab is known as lectin-pathway-inhibitor. Specifically, it blocks the MASPS-2 enzyme.
Omeros did not intend to treat COVID-19 with Narsoplimab. It was developed to treat a side effect of a particular type of leukemia treatment involving stem cells. The procedure, known as hematopoietic stem cell transplantation, can also trigger the lectin pathway and the MASPS-2 enzyme, causing symptoms similar to COVID-19.
Dr. Alessandro Rambaldi had been doing research on Narsoplimab and stem cells when the coronavirus swept through Bergamo, Italy, in early 2020. Rambaldi is a professor of hematology and clinical pharmacology at the State University of Milan and director of the hematology unit at Bergamo Hospital.
As Bergamo became an epicenter of COVID-19, Rambaldi realized that the disease caused a lectin pathway response similar to that of hematopoietic stem cell transplantation. In early March, he asked Omeros if it could provide Narsoplimab.
“We were looking desperately for some effective drugs, for ones that were anti-inflammatory,” said Rambaldi. “Dr. Demopulos was very generous in providing us with what he could.”
Because Narsoplimab is not yet on the market, Omeros could only supply enough doses for six patients with severe COVID-19. The results, later published in the journal Immunobiology, were impressive. All six patients recovered.
When the coronavirus surged in Italy again late last year, Rambaldi tested Narsoplimab on another 10 patients. These patients were even sicker than the original six who received the drug. They had all been intubated on a ventilator. Eight of the 10 survived after receiving Narsoplimab. That looks promising when compared to the fatality rate for patients with COVID-19 who are sick enough to be in an intensive care unit, which ranges from 50% to 65%.
More recently, researchers at the drug company Eli Lilly published an article in the Journal of Allergy and Infectious Diseases about a patient with severe COVID-19 who was on a ventilator. All treatments had failed until Narsoplimab was tried. The patient recovered in four weeks.
Rambaldi, though, noted the limits of this research.
“These are not controlled trials and are a small number of patients treated,” he said.
Studies with larger numbers of patients are needed before Narsoplimab can be approved by the Food and Drug Administration. Currently, the drug is part of the I-SPY COVID-19 Trial sponsored by the Quantum Leap Healthcare Collaborative. It will test various drugs in groups of about 125 COVID-19 patients and test them against a control group of patients who will receive the standard care. Demopulos hopes Narsoplimab will eventually be approved by the FDA for the treatment of COVID-19.
It is tempting to suggest that there is little urgency for drugs such as Narsoplimab because coronavirus vaccines are now being distributed.
“Vaccines are one prong in the fight against COVID, but I think they are only one prong,” said Demopulos. “To ignore therapeutics is unwise.”
The coronavirus mutates frequently, and while vaccines have thus far proven relatively effective against variants of the virus, it is quite possible that a variant will eventually develop that can evade the defenses set up by vaccines.
“We need to be prepared for future waves of the virus and for those who will not be vaccinated,” added Rambaldi.
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Some people will simply refuse to be vaccinated, and others have immune systems that preclude them from receiving a vaccine. For those people, a drug such as Narsoplimab could prove to be a lifesaver.
