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
Eigerplans to submit data to FDA for Emergency Use Authorization (EUA)
- Management to host conference call today at
8:30 AM ET
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,
"These data demonstrate that a single subcutaneous injection of Lambda has the potential to be a convenient, 'one and done' treatment to reduce the severity of COVID-19, reducing hospitalizations and death – even in a vaccinated population," said
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.
"Lambda has demonstrated a reduction of risk in COVID-19-related hospitalizations or deaths in this clinical study in a predominantly vaccinated population, something that no other investigational drug has achieved – this is a game-changing event," said Principal Investigator, Professor of Health Research Methods, Evidence, and Impact at McMaster University, Hamilton,
About TOGETHER Study
TOGETHER is a multi-center, investigator-sponsored, randomized, placebo-controlled adaptive platform Phase 3 study evaluating therapeutics in newly diagnosed, high-risk, non-hospitalized patients with COVID-19. TOGETHER is the largest placebo-controlled study in COVID-19 and has evaluated eleven different therapeutic agents for non-hospitalized COVID-19 patients. This evaluation of Lambda versus placebo was the second largest study to date of a COVID-19 therapeutic. Eligibility criteria required that all patients had laboratory-confirmed mild or moderate COVID-19, and were randomized within 7 days of symptom onset. High-risk criteria were defined by patients having at least one of the following, including but not limited to: > age 50, diabetes, hypertension, CV disease, lung disease, kidney disease, obesity, etc. The study enrolled patients regardless of vaccination status or variant strain of SARS-CoV-2. The primary endpoint was a clinical outcome comparing hospitalizations or emergency room visits greater than six hours after a single subcutaneous injection of Lambda versus placebo. The DSMB provided independent oversight for the trial and had previously discontinued other therapeutics due to observed futility. The TOGETHER study recruited from twelve sites in
About Peginterferon Lambda
Lambda is a late-stage, first-in-class, type III interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections and has been well-tolerated in clinical studies.
Lambda is to be administered as a single subcutaneous injection so that it can be prescribed and administered at the first sign of infection or at first awareness of an exposure, potentially helping patients avoid severe illness that can lead to hospitalization and death.
IFN lambdas are critical for maintaining a balanced antiviral response in the respiratory tract. They are induced at lower viral burden before type I IFNs to limit the initial infection by inducing viral resistance to cells and helping them deal with the virus load. IFN lambda lacks the strong pro-inflammatory effects of type I IFNs and are tissue-protective and anti-inflammatory. Administration of IFN lambda has been shown to suppress viral replication while stopping 'cytokine storm' from developing.
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, regulatory objectives, business strategy and plans and objectives for future operations, are forward looking statements. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our anticipated significant milestones in 2022; the timing of our ongoing and planned clinical development; our ability to obtain an Emergency Use Authorization from FDA for Peginterferon Lambda for COVID-19; our capability to provide sufficient quantities of any of our product candidates, including Peginterferon Lambda, to meet anticipated full-scale commercial demands; our ability to finance the continued advancement of our development pipeline products; and the potential for success of any of our product candidates. Various important factors could cause actual results or events to differ materially from the forward-looking statements that
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