Eiger’s single dose Peginterferon Lambda for COVID-19 50% reduced risk of hospitalization or emergency room visits in a predominantly vaccinated population in phase 3 TOGETHER study
Eiger’s single dose Peginterferon Lambda for COVID-19 50% reduced risk of hospitalization or emergency room visits in a predominantly vaccinated population in phase 3 TOGETHER study

Eiger’s single dose Peginterferon Lambda for COVID-19 50% reduced risk of hospitalization or emergency room visits in a predominantly vaccinated population in phase 3 TOGETHER study

  • Second largest study to date in COVID-19 outpatients (N = 1,936)
  • Very superior to placebo, with a 99.91% probability of superiority at the primary endpoint
  • 60% reduced risk of COVID-19-related death
  • Primary endpoint obtained across multiple SARS-CoV-2 variants, including omicron
  • Eiger plans to submit data to FDA for Emergency Use Authorization (EUA)
  • The management is holding a telephone meeting today at 8:30 ET

PALO ALTO, California, March 17, 2022 / PRNewswire / – Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-phase biopharmaceutical company focusing on the development of innovative therapies for the treatment and cure of Hepatitis Delta Virus (HDV) and other serious diseases, announced today that Peginterferon Lambda (Lambda) significantly reduced the risk of COVID-19-related hospitalizations or emergency room visits for more than six hours with 50% (primary endpoint) and death with 60% in phase 3 TOGETHER study, a multicenter, randomized, double-blind, placebo-controlled study of non-hospitalized adult patients with COVID-19 who are at high risk of developing serious disease.

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

Final analyzes using a Bayesian analytical framework showed:

  • Lambda very superior to placebo at the primary endpoint, with a probability of superiority of 99.91%, exceeding the pre-specified 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 after symptom onset
    • 2.7% of patients (25/916) who received Lambda were hospitalized or visited the emergency room through day 28, compared with 5.6% of patients (57/1020) who received placebo
  • Risk reduction of COVID-19-related admissions was observed:
    • 42% (95% BCI: 5–66%) risk reduction with treatment ≤ 7 days after symptom onset
    • 60% (95% BCI: 18–82%) risk reduction with treatment ≤3 days after symptom onset
  • One COVID-19-related death in the Lambda group; four in the placebo group
  • The incidence of any adverse reactions occurring was similar between the lambda and placebo groups, which were primarily injection site reactions.

In addition, viral sequencing was performed on all patients. The primary endpoint was obtained across all tested variants, including omicron. Based on these data, Eiger believes that Lambda has the potential to be effective against any newly emerged variant.

Eiger plans to discuss the results with the FDA and submit an EUA as soon as possible.

“These data show 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, reduce hospitalizations and deaths – even in a vaccinated population,” said Eiger’s President and CEO, David Cory. “With the continued global impact of COVID-19, we are encouraged by this data and look forward to supporting the global public health response. We are grateful to the patients, investigators and sites that participated in this clinical trial and we look forward to to discuss these findings with the FDA and submit an EUA application to add Lambda to the evolving armamentarium of COVID-19 therapy. “

Lambda stimulates immune responses critical for congenital defenses with a mechanism of action that is potentially agnostic to variants of SARS-CoV-2 and resistance concerns with other therapies. If approved, Lambda can be prescribed more broadly to help reduce the severity of the disease, hospitalizations and deaths, as well as reduce the likelihood of infection after exposure among adults.

“Lambda has demonstrated a reduction in the risk of COVID-19-related hospitalizations or deaths in this clinical trial in a predominantly vaccinated population, something that no other experimental drug has achieved – this is an event that changes the game,” said lead researcher Professor of Health Research Methods, Evidence and Impact at McMaster University, Hamilton, Canada, Edward MillsPhD leading TOGETHER study with co-investigator, associate professor of medicine, papal catholic university in Minas Gerais, Brazil, Gilmar Reis, MD, PhD. The COVID-19 pandemic continues to be a global public health emergency, and outpatient treatments that can be administered quickly and effectively to newly diagnosed SARS-CoV-2 patients are desperately needed with a goal of reducing COVID-19 complications . “

About TOGETHER Examination
TOGETHER is a multicenter, 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 drug. 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 with at least one of the following, including but not limited to:> 50 years, diabetes, hypertension, CV disease, lung disease, kidney disease, obesity, etc. The study included 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 more than six hours after a single subcutaneous injection of Lambda versus placebo. DSMB provided independent oversight of the trial and had previously discontinued other treatment due to observed futility. That TOGETHER study recruited from twelve sites in Brazil. For more information, please visit www.clinicaltrials.gov (NCT04727424) and www.togethertrial.com.

About Peginterferon Lambda
Lambda is a late-stage, first-class, type III interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections and that have been well tolerated in clinical trials.

Lambda should be administered as a single subcutaneous injection so that it can be prescribed and administered at the first sign of infection or at the first awareness of an exposure, potentially helping patients avoid serious illness that could lead to hospitalization and death.

IFN lambdas is essential for maintaining a balanced antiviral response in the airways. They are induced by lower viral load before type I IFNs to limit the initial infection by inducing viral resistance to cells and helping them deal with the viral load. IFN lambda lacks the strong pro-inflammatory effects of type I IFNs and is tissue protective and anti-inflammatory. Administration of IFN lambda has been shown to suppress viral replication while stopping the development of ‘cytokine storm’.

Eiger develops Lambda to treat HDV infection. Lambda has been administered to over 3,000 subjects in 23 clinical trials with HBV, HCV, HDV and COVID-19. Lambda is an experimental drug and has not yet been approved for any indication. Eiger has received the Orphan Designation from the US Food and Drug Administration (FDA) and the European Medicines Agency, and the Fast Track and Breakthrough Therapy Designation from the FDA for Lambda in HDV.

Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb.

CONFERENCE CALL
On 8:30 Eastern Time Today, March 17, 2022Eiger will host a conference call to discuss the results of Phase 3 TOGETHER examination. The live and replayed webcast of the call will be available via the company’s website at www.eigerbio.com. To join the live call by phone, call (844) 743-2495 (US) or (661) 378-9529 (International) and enter conference ID 8990285. The webcast will be archived and available for replay for at least 90 days after the event.

About Eiger
Eiger is a commercial-phase biopharmaceutical company focusing on the development of innovative therapies for the treatment and cure of Hepatitis Delta Virus (HDV) and other serious diseases. The Eiger HDV platform includes two state-of-the-art phase 3 therapies targeting critical host processes involved in viral replication. All five Eiger Rare Disease Programs have been awarded the FDA Breakthrough Therapy Designation.

For more information on Eiger and its clinical programs, please visit www.eigerbio.com.

Note regarding forward-looking statements
This press release contains forward-looking statements in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements except statements about historical facts, including statements about our future financial situation, timing and results 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, prospects, analyzes or current expectations regarding, among other things, our expected significant milestones in 2022; the timing of our ongoing and planned clinical development; our ability to obtain an FDA Emergency Use Approval for Peginterferon Lambda for COVID-19; our ability to supply sufficient quantities of any of our product candidates, including Peginterferon Lambda, to meet expected full-scale commercial requirements; our ability to fund the continued development of our development pipeline products; and the potential for success for any of our product candidates. Various important factors may cause actual results or events to differ materially from the forward-looking statements made by Eiger, including additional relevant risks and uncertainties described in the “Risk Factors” sections of the annual report on Form 10-K for the year ended. December 31, 2021 and Eiger’s subsequent applications to the SEC. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only from the date on which they are made. Eiger does not assume and specifically disclaims any obligation to update forward-looking statements, whether as a result of new information, future events, changed circumstances or otherwise.

Investors:
Sri Ryali – CFO
[email protected]
Sylvia Wheeler – Board House Life Science Advisors
[email protected]

Media:
Aljanae Reynolds – Life Science Advisors in the wheelhouse
[email protected]
Edelman for Eiger BioPharmaceuticals
[email protected]

SOURCE Eiger BioPharmaceuticals, Inc.

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