Eiger’s Single-dose Peginterferon Lambda for COVID-19 Reduced Risk of Hospitalization or ER Visits by 50% in a Predominantly Vaccinated Population in Phase 3 TOGETHER Study

• Second largest study to date in COVID-19 outpatients (N=1,936)
• Highly superior compared to placebo, with a probability of superiority of 99.91% on the primary endpoint
• 60% reduced risk of COVID-19-related death
• Primary endpoint achieved across multiple SARS-CoV-2 variants, including omicron
• Eiger plans to submit data to FDA for Emergency Use Authorization (EUA)
• Management to host conference call today at 8:30 AM ET

Excerpt from the Press Release:

PALO ALTO, Calif., March 17, 2022 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious diseases, today announced that Peginterferon Lambda (Lambda) significantly reduced the risk of COVID-19-related hospitalizations or emergency room visits greater than six hours by 50% (primary endpoint) and death by 60% in the Phase 3 TOGETHER study, a multi-center, randomized, double-blind, placebo-controlled study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness.

The Phase 3 TOGETHER study of Lambda is the second largest study to date of a COVID-19 therapeutic. Final analyses evaluated data from 1,936 patients, with 84% of patients having received at least a single dose of any COVID-19 vaccine.

Final analyses using a Bayesian analytic framework showed:

• Lambda highly superior compared to placebo on the primary endpoint, with a probability of superiority of 99.91%, surpassing the prespecified superiority threshold of 97.6%
• 50% risk reduction was observed [95% Bayesian credible interval (95% BCI): 23–69%] of COVID-19-related hospitalizations or emergency room visits compared to placebo in patients treated ≤7 days of symptom onset
  • 2.7% of patients (25 / 916) who received Lambda were hospitalized or had ER visits through Day 28, compared to 5.6% of patients (57 / 1020) who received placebo
• Risk reduction of COVID-19-related hospitalizations was observed:
  • 42% (95% BCI: 5–66%) risk reduction when treated ≤7 days of symptom onset
  • 60% (95% BCI: 18–82%) risk reduction when treated ≤3 days of symptom onset
• One COVID-19-related death in Lambda group; four in placebo group
• Incidence of any treatment emergent adverse events was similar between Lambda and placebo groups, which were primarily injection site reactions

In addition, viral sequencing was conducted on all patients. The primary endpoint was achieved across all variants tested, including omicron. Based on these data, Eiger believes Lambda has the potential to be effective against any new arising variants.

Click the button below to read the entire Press Release:

Continue Reading The Press Release