Eiger eager to send COVID-19 drug to FDA after hospitalizations, deaths slashed—including against omicron

Eiger BioPharmaceuticals' drug, licensed from Bristol Myers Squibb in 2016, halved the risk of hospitalizations or emergency room visits lasting longer than six hours in patients with COVID-19, including those with the omicron variant, in a phase 3 trial. 

With the 50% reduction, which means the drug met its primary goal, Eiger is headed to the FDA "as soon as possible" for emergency use authorization, executives said in an interview with Fierce Biotech. The FDA is first priority, then the European Medicines Agency and other countries to follow. 

The study of peginterferon Lambda—colloquially truncated to Lambda—was conducted across 12 trial sites in Brazil from July 2021 to February 2022. That time frame means the drug was delivered to patients who had SARS-CoV-2's various mutations: alpha, gamma, delta, zeta and omicron, said Ingrid Choong, Ph.D., senior vice president of clinical development. The trial enrolled patients who were non-hospitalized but at high risk of progressing to severe illness. 

The late-stage trial, dubbed TOGETHER, included 1,936 patients who received either the single-dose drug or placebo. About 84% of the patients had already received at least one dose of a COVID-19 vaccine. Choong declined to disclose which vaccines the patients had previously received. She also declined to disclose the age range of patients involved in the study but said Eiger doesn't believe the drug will be restricted to just high-risk patients, should it be given an emergency green light. 

Eiger's shares were up nearly 22% premarket to $6.93 apiece on Thursday morning. 

CEO David Cory positioned the drug's potential as serving an unmet need for high-risk patients, and he emphasized the pandemic isn't over as evidenced by rising case rates in some areas of Europe and China in recent days. 

"We don't see COVID going away anytime soon and the need for a one-and-done, easy-to-administer treatment for newly diagnosed COVID-19, we believe is in high demand," Cory said.

And, since most of the patients were vaccinated, Cory said Lambda is expected to be "well received" by regulators and goverment authorities. 

Delivered under the skin, Lambda led to the 50% reduction when patients were treated within seven days of symptom onset. When given within three days of first symptoms, it led to a 60% reduction in hospitalizations.

Lambda reduced risk of death by 60%, with one patient dying from COVID-19 in the Lambda group versus four in the placebo set. Of the 916 patients who received Lambda, 25 went to the hospital or had ER visits through Day 28, whereas 57 of 1,020 people in the placebo group did. 

The primary endpoint looked at hospitalizations and ER visits lasting longer than six hours, because the trial site "investigators rightfully so wanted to ensure that they were only capturing ER visits that were related to severe COVID disease"; that time frame was one way to measure it, Choong said.

Adverse events were "indistinguishable" between those who received Lambda and those who got the placebo, Choong said. Injection site reactions were the driver of reported adverse events, the company said. 

Eiger wants to position the drug as an at-home treatment. It has been studied in more than 20 clinical trials across hepatitis B, hepatitis C and hepatitis delta virus (HDV). Lambda has orphan-drug designation from the FDA and European Medicines Agency. The FDA has also given it fast-track and breakthrough-therapy designations in HDV.

Lambda is also in a late-stage trial in patients with HDV. The phase 3 study, dubbed LIMT-2, is slated to enroll 150 patients, the company said March 10 in its full-year 2021 results update.

Eiger already has one drug on the market, Zokinvy, which is used to treat progeria, an ultra-rare genetic disease that causes rapid aging. The FDA approved the drug in November 2020, and it became the most expensive pharmacy med in the U.S. in 2021.