Experimental Interferon Could be New Weapon Against COVID-19 Hospitalization, Deaths
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Eiger BioPharmaceuticals announced that its single-dose therapeutic Peginterferon Lambda (Lambda) reduced the risk of hospitalization and emergency room visits by 50% in a predominantly vaccinated population.
Eiger boasts the second-largest study to date in COVID-19 outpatients, with nearly 2,000 participants recruited from 12 sites in Brazil. The Phase III trial results indicate that Lambda was highly superior as compared to placebo, and showed that only 2.7% of those treated with the therapeutic required hospitalization or an emergency room visit. Additionally, treatment with Lambda cut the risk of COVID-19 related death by 60%. Eiger also reports that only one COVID-19 related death occurred in the treatment group.
"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 Eiger President and CEO David Cory.
Lambda is a late-stage type III interferon (IFN) that works by stimulating immune responses that are critical in providing the body protection from viral infections. More specifically, IFN lambdas are important in maintaining a balanced antiviral response in the respiratory tract, a system that is heavily impacted in COVID-19 infections. Importantly, using IFN lambdas helps to prevent the “cytokine storm”, a life-threatening systemic inflammatory syndrome that can stem from other activated IFNs, from developing.
Eiger is looking forward to discussing the results with the U.S. Food and Drug Administration with eyes on Emergency Use Authorization (EUA) approval, which allows unapproved medical treatments to be used in emergencies where there are no other adequate alternatives. If authorized, Eiger believes that Lambda could be prescribed more broadly to reduce the number of hospitalizations, illness severity and deaths among those infected with COVID-19. It also stands a chance to reduce the probability of infection after exposure in adults.
Currently, the FDA has approved Veklury (remdesivir) for use in certain COVID-19 patients. Several other treatments are also available under EUA, including Olumiant (baricitinib), REGEN-COV (casirivimab and imdevimab) and Actemra (tocilizumab).
"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 Edward Mills, Ph.D. "The COVID-19 pandemic continues to be a global public health emergency, and outpatient treatments that can be quickly and efficiently administered to newly diagnosed SARS-CoV-2 patients are desperately needed with a goal of reducing COVID-19 complications."
Eiger believes that its treatment may also be potent against future emerging variants of SARS-CoV-2. After treatment, viral sequencing was conducted on all patients which showed that the primary endpoints were achieved across all variants tested, including Omicron. Because Lambda stimulates immune responses critical to innate defenses, it potentially has a mechanism of action that is agnostic to variants of SARS-CoV-2.
Eiger is also developing Lambda for the treatment of hepatitis delta virus (HDV) which causes Hepatitis D, a liver infection. Lambda has received Orphan Designation from the FDA and European Medicines Agency, as well as Fast Track and Breakthrough Therapy Designation, in HDV.