(MENAFN- PR Newswire)
Phase 3 TOGETHER data showed that early treatment with a single dose of peginterferon lambda (Lambda) in patients with mild to moderate COVID-19 infections resulted in a significant reduction in clinical events
– Lambda reduced hospitalization or emergency branch visits by 51% (primary endpoint)
– Lambda reduced hospitalization by 42% and death from COVID-19 by 50%
– Effects consistent with several dominant variants of SARS-CoV-2 in a vaccinated population
PALO ALTO, Calif. , Feb. 8, 2023 /PRNewswire/ — Eiger BioPharmaceuticals Inc. (Nasdaq: eigr), a commercial-stage biopharmaceutical company whose goal is to develop cutting-edge treatments for hepatitis delta virus (HDV) and other diseases, today announced the publication of data from the investigator-sponsored phase 3 JUNTOS study in COVID-19 patients in the New England Journal of Medicine (NEJM). The study, which evaluated outpatients newly diagnosed with mild to moderate COVID-19, found that among participants vaccinated primarily with COVID-19, the single-dose remedy with Eiger’s investigational agent, peginterferon lambda, resulted in a significant reduction in clinical events. The manuscript titled “Effect of Early Remedy with Pegylated Interferon Lambda in COVID-19 Patients” will be published in the NEJM factor of February 9, 2023 and follows key protection and efficacy data announced on March 17, 2022.
“We are excited to see the positive effects of TOGETHER published in the New England Journal of Medicine, highlighting the importance of the trial that showed that a single dose of peginterferon lambda resulted in significant relief in COVID-19 risk. hospitalizations or deaths in a primarily vaccinated population,” said Gilmar Reis, MD, PhD, co-principal investigator of JUNTOS and associate professor of medicine at McMaster University, Hamilton, Canada and Pontifical Catholic University of Minas Gerais, Brazil.
“Peginterferon lambda has great healing potential and we continue to see the emergence of competitive variants of the virus that spread around the world and are less vulnerable to vaccines and are remedied with antibodies,” said Jordan Feld, MD, MPH, associate professor of medicine. at the University of Toronto and Principal Investigator at the Toronto Liver Disease Centre and Toronto General Hospital Research Institute and Co-Principal Investigator of JUNTOS. “Resistance due to variants or new strains of the virus may also be a factor with some therapies, however, it may not be a factor with peginterferon lambda due to its mechanism of action which consists of activating multiple virus destruction pathways. “
Endpoint number one is a final result comprised of hospitalization or emergency branch visits of more than six hours. Secondary endpoints come with SARS-CoV-2 viral clearance, all-cause hospitalization, COVID-19 mortality, days in the hospital and ventilator, and adverse events. In the study, 931 patients gained peginterferon lambda and 1018 received placebo. This is one of the first trials with a predominantly vaccinated population, with 84% of the population vaccinated before entering the test. the emergence of several variants of fear from COVID-19.
The publication primarily notes the results, highlighting a 51% relief in COVID-19-related hospitalizations or ER visits lasting longer than six hours (the number one end point) for participants receiving peginterferon lambda in compared with placebo, with 2. 7% (25 of 931) of participants randomized to peginterferon lambda experiencing a number one endpoint event, compared with 5. 6% (57 of 1018) (ratio risk ratio 0. 49, 95%, Bayesian credibility period 0. 30-0. 76, posterior probability 99. 9%) among patients randomized to placebo. This effect was maintained in subgroup analyses, adding COVID-19-related hospitalization alone (relative threat 0. 57, 95% Bayesian credibility periods 0. 33-0. 95) and COVID-19-related hospitalization or death (relative threat 0. 59, 95 % Bayesian credibility period 0. 35-0. 97). Effects were consistent between dominant variants and vaccination status. Among other people with a higher viral point at baseline, peginterferon lambda resulted in a lower viral load and a higher percentage of patients who cleared SARS-COV-2 RNA by day 7, compared with placebo. The occurrence of adverse events was similar in the two groups. Primary examination occasions occurred on average five days (interquartile range 3-7 days) after randomization. The effect of the remedy for peginterferon lambda was most pronounced in patients treated within 3 days of symptom onset.
Peginterferon lambda was consistent in the direction of effect across all secondary outcomes. The threat of hospitalization for COVID-19 or death from any cause was reduced by 47% (relative threat, 0. 53, 95% Bayesian credibility period, 0. 31 to 0. 91) in participants receiving peginterferon lambda . In patients who received the remedy within 3 days of symptom onset, greater effects of the remedy were seen on peginterferon lambda organizing, adding 65% relief in COVID-19-related hospitalizations (relative threat 0Array35 , 95% Bayesian credible period 0. 15-0. 75), 81% threat relief in death from any cause (relative threat 0. 19 [0/567 vs. 3/590], Bayesian credible period at 95% 0. 01-1. 57) and 89% relief from threat in unvaccinated patients (relative threat, 0. 11; 95% Bayesian credibility period, 0. 01-0. 83). There was one COVID-19 related death in the peginterferon lambda organization and 4 in the placebo organization. The occurrence of any treatment-emergent adverse events was similar between the peginterferon lambda and placebo organizations, which were primarily injection site reactions.
“These data demonstrate the possibility that peginterferon lambda interferon confers significant benefits to COVID-19 patients and recommend the possibility of other respiratory viral infections,” said David Apelian MD, PhD, interim executive director of Eiger. “We have over 100,000 readily available peginterferon lambda syringes with more production intermediates up to a capacity of 10 million sets if needed. We thank the participants and investigators of the clinical trials for whom none of this would be possible. As a component of our ongoing portfolio prioritization process, we continue to explore opportunities for the emergency use of peginterferon lambda for COVID-19 outside the United States.
About peginterferon lambda Peginterferon lambda is the first experimental type III interferon of its kind to stimulate immune responses, an essential element for viral infections of host coverage and has been well tolerated in clinical studies. Peginterferon lambda deserves to be given as a simple subcutaneous injection so that it can be prescribed and given at the first sign of infection or first knowledge of an exposure, which could help patients avoid serious illness that can lead to hospitalization and death.
Lambda IFNs are to maintain a balanced antiviral reaction in the respiratory tract. They are induced to a lower viral load earlier than type I IFNs to restrict initial infection by inducing viral resistance to cells and helping them cope with the viral load. IFN lambda lacks the potent pro-inflammatory effects of type I IFN and protects tissues and is anti-inflammatory. Administration of IFN lambda has been shown to suppress viral replication while preventing the development of the “cytokine storm. “
Eiger develops peginterferon lambda for the remedy of HDV infection. Peginterferon lambda was administered to more than 4000 subjects in 28 clinical trials in HBV, HCV, HDV, and COVID-19. Peginterferon lambda is an investigational agent and is not yet approved for any indication. Eiger has earned orphan drug designation from the U. S. Food and Drug Administration. The U. S. Food and Drug Administration (FDA) and European Medicines Agency, and the FDA’s Fast Track and Breakthrough Therapy designation for peginterferon lambda in HDV.
Eiger has received the international rights to peginterferon lambda from Bristol-Myers Squibb.
About the TOGETHER Study TOGETHER is a multicenter, investigator-sponsored, randomized, placebo-controlled Phase 3 study comparing remedies in newly diagnosed, high-risk, non-hospitalized patients with COVID-19. TOGETHER is the largest placebo-controlled study of COVID-19 and evaluated 11 other curative agents for non-hospitalized COVID-19 patients. This evaluation of peginterferon lambda compared with placebo was the largest study to date of a treatment for COVID-19. Eligibility criteria required all patients to have laboratory-confirmed mild to moderate COVID-19 and be randomized within seven days of symptom onset. High threat criteria were explained by patients with at least one of the following, adding but not limited to: 50 years, diabetes, hypertension, cardiovascular disease, lung disease, kidney disease, obesity, etc. Array The exam recruited patients regardless of their vaccination status. or a variant strain of SARS-CoV-2. The number one endpoint was an endpoint clinical outcome comparing hospitalizations or emergency branch visits more than six hours after a subcutaneous injection of peginterferon lambda in a single person compared to placebo. The Data Security Monitoring Board provided independent oversight of the trial and had in the past halted other remedies due to observed futility. The JUNTOS exam recruited 12 sites in Brazil and five sites in Canada.
For more information, please (NCT04727424, NCT04967430) and Array
About Eiger Eiger is a commercial-stage biopharmaceutical company whose goal is to develop cutting-edge treatments for hepatitis delta virus (HDV) and other serious diseases. in viral replication. Eiger’s five rare disease systems have earned the FDA’s breakthrough treatment designation: lonafarnib and peginterferon lambda for HDV, Zokinvy for progeria, and avexitide for congenital hyperinsulinism and postbariatric hypoglycemia.
To learn more about Eiger and its clinical programs, visit.
Forward-Looking Statements This press release comprises forward-looking statements within the meaning of the port provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of past fact, with the addition of statements relating to our long-term monetary condition , and the effects of clinical effects, prospective products, preclinical and clinical projects, regulatory objectives, business strategy, and plans and objectives for long-term operations are forward-looking statements. Forward-looking statements are our existing statements relating to our existing intentions, beliefs, projections, prospects, analyzes or expectations relating to, among other things, the timing of our ongoing and expected clinical progression; the adequacy of our money, money equivalents and investments to finance our operations; the likelihood of identifying peginterferon lambda registry pathways for COVID-19 and other viral respiratory infections; our ability to obtain sufficient quantities of any of our product applicants to meet expected large-scale advertising demands; our ability to finance, independently or through collaborations, the continued advancement of our product line progression and launches; and the prospect of good fortune from any of our products or product applicants. Several vital points may cause actual effects or occasions to differ materially from Eiger’s forward-looking statements, adding further applicable dangers and uncertainties described in the “Risk Factors” sections of the Quarterly Report on Form 10-Q for the quarter. closed in september. 30, 2022 and Eiger’s upcoming SEC filings. Forward-looking statements contained in this press release are based on existing data provided to Eiger and speak only as of the date they were made. Eiger does not adopt and, in particular, disclaims any legal responsibility to update any forward-looking statement, whether as a result of new data, long-term events, superseded cases, or otherwise.
Investor Contacts:Sylvia WheelerWheelhouse Life Science Advisors[email protected]
SOURCEIiger BioPharmaceuticals, Inc.
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