US-based Eiger BioPharmaceuticals’ investigational agent, peginterferon lambda (Lambda), significantly reduces the number of clinical events in COVID-19 patients with mild to moderate cases, according to new phase 3 data published in the New England Journal of Medicine.
The TOGETHER study, which evaluated newly diagnosed outpatients considered to be at a higher risk, demonstrated a 51% reduction in COVID-19-related hospitalisations or emergency room visits greater than six hours for patients receiving a single dose of Lambda compared to placebo.
The effects were consistent across dominant variants and vaccination status, the company said, but the treatment effect for Lambda was more pronounced in patients who were treated within three days of symptom onset, including a 65% reduction of COVID-19 related hospitalisation and an 81% risk reduction in all-cause death.
Among individuals with a high viral level at baseline, Lambda resulted in lower viral loads and a higher percentage of patients clearing SARS-COV-2 RNA by day seven, compared to placebo.
“This data demonstrates the potential of peginterferon lambda to confer a meaningful benefit for patients with COVID-19 and suggests potential for other respiratory viral infections,” said David Apelian, interim chief executive officer, Eiger.
Apelian added that the company has “over 100,000 peginterferon lambda syringes readily available with additional manufacturing intermediates to support a capacity of over ten million units if needed”.
The study included multiple COVID-19 variants of concern and was among the first trials to include a predominantly vaccinated population, with 84% of patients having received vaccination prior to entry.
“Peginterferon lambda has tremendous therapeutic potential, and we continue to see the emergence of aggressive variants of the virus spreading around the globe which are less sensitive to both vaccines and treatment with antibodies,” said Jordan Feld, associate professor of medicine at the University of Toronto and senior scientist at Toronto Centre for Liver Disease and Toronto General Hospital Research Institute and co-lead investigator for TOGETHER.
“Resistance due to variants or new strains of the virus could be an issue with some therapies, but this may not be a concern with peginterferon lambda due to its mechanism of action that involves activation of multiple virus-killing pathways,” Feld added.
The new data follows positive top line safety and efficacy results, announced by the company in March 2022 showing that Lambda reduced the risk of COVID-19-related hospitalisations or emergency room visits greater than six hours by 50% and death by 60%.