A closely related substance, alfa-interferon, has been injected as a drug to treat hepatitis C and other viral infections, as well as cancer. But alfa-interferon has proved toxic to numerous organ systems, as receptors for alfa-interferon abound on the surfaces of cells in many of the bodys tissues and on immune cells. Patients receiving alfa interferon report often-debilitating side effects such as fever, chills, intense muscle aches, nausea and more.

Receptors for lambda-interferon, though, are largely limited to the linings of the lungs, airways and intestine serendipitously, the main places SARS-CoV-2 strikes as well as the liver. As a result, side effects resulting from injecting this interferon tend to be quite mild, Glenn said.

That turned out to be the case in this trial. You couldnt tell who got PEG-lambda and who got placebo, Glenn said. This wasnt surprising, he added, because the drug has already been given to more than 3,000 people in other trials and been proven to be well tolerated even when given weekly for a year.

Some years ago Glenn, who is the Joseph D. Grant Professor II, founded Eiger BioPharmaceuticals Inc., a biotechnology company that acquired the rights to lambda-interferon to develop it as a drug for hepatitis D. When the COVID-19 pandemic struck, the company turned its attention to the new pathogen.

Glenn has since forged ties with the TOGETHER network, which operates test sites in countries around the world and has methodically conducted clinical trials of numerous prospective therapeutic agents for COVID-19.

The PEG-lambda trial took place between June 2021 and February 2022 at 12 sites in Brazil and five sites in Canada. To participate, patients had to test positive on a COVID-19 rapid-antigen test and receive PEG-lambda or a placebo within seven days of manifesting COVID-19 symptoms. Their average age was 43. Slightly more than half were women, and about 95% were mixed race. Only 3% were white. Some 85% had been vaccinated for COVID-19.

About 930 patients received a single subcutaneous injection of PEG-lambda, and about 1,020 were given a placebo injection. Of patients receiving PEG-lambda, 25 (2.7%) were hospitalized or, due to a shortage of hospital space, placed under observation for more than six hours in an emergency clinic within four weeks for COVID-19, versus 57 (5.6%) of patients who received the placebo.

Vaccinated patients treated with PEG-lambda experienced a 51% reduction in hospitalization relative to placebo. In unvaccinated patients treated within the first three days of symptom onset, there was an 89% reduction compared with placebo the same 89% reduction that was observed with Pfizers Paxlovid.

Only 11 (1.9%) of the 567 patients treated with PEG-lambda within the first three days after symptoms appeared wound up in the hospital within four weeks of getting the shot, versus 28 (3.1%) of the 590 who got a placebo injection within three days of symptom onset a relative reduction of 58%.

PEG-lambda was equally effective against several SARS-CoV-2 variants, including omicron. There were no deaths among patients treated with PEG-lambda within three days of symptoms onset. There were four COVID-19-related deaths in the placebo group.

With vaccine-induced immunity wearing off more rapidly than has been hoped, new SARS-CoV-2 variants constantly striving to outwit our immune systems, and people shying away from repeated rounds of vaccination due to fear of side effects both real and imagined (or due to vaccine fatigue), the need for effective COVID-19 therapies is paramount, Glenn said.

But even the best treatments available today have drawbacks.

Paxlovid is a very good drug, Glenn said of the drug now most commonly prescribed for newly infected COVID-19 outpatients. But its not perfect. You need to take six pills a day for five days. One of its component medications can interfere with your metabolism of many other drugs. The older you get, the more drugs youre likely to be taking, and the more susceptible you are to COVID-19.

Glenn is an inventor on intellectual property associated with the use of lambda-interferon for treating COVID-19. While he no longer actively consults for Eiger BioPharmaceuticals, he owns equity in the company and sits on its board of directors. The company has supplied PEG-lambda free of charge to several investigators for use in independent clinical trials, including this one. Eiger BioPharmaceuticals played no role in the design of this trial, patient recruitment, data acquisition, analysis or any other function in the trials operation, and was informed of the trials results only after its completion.

Additional researchers from Eiger BioPharmaceuticals Inc., Cardresearch, Platform Life Sciences, RainCity Analytics and the TOGETHER Network contributed to the work.

The study was funded by FastGrants, the Rainwater Charitable Foundation, the Latona Foundation and Eiger BioPharmaceuticals Inc.

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Single drug injection wards off COVID-19 hospitalizations, in ... - Stanford Medical Center Report