Single-dose peginterferon lambda for COVID-19 reduced risk of hospitalization or ER visits by 50% in phase III TOGETHER study.- Eiger BioPharma
Eiger BioPharmaceuticals, Inc. 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 III 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 III 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 ; i. 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%. ii. 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 less than 7 days of symptom onset. iii. 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 iv. Risk reduction of COVID-19-related hospitalizations was observe less than a. 42% (95% BCI: 5–66%) risk reduction when treated 7 days of symptom onset. b. 60% (95% BCI: 18–82%) risk reduction when treated less than 3 days of symptom onset .c 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. Eiger plans to discuss the results with FDA and submit an EUA as soon as possible.
Lambda stimulates immune responses critical to innate defenses with a mechanism of action potentially agnostic to variants of SARS-CoV-2 and resistance concerns with other treatments. If authorized, Lambda could be prescribed more broadly to help reduce illness severity, hospitalizations, and deaths, as well as reduce the probability of infection following exposure, among adults.
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