16 October 2020 - - US-based biopharmaceutical company Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) has released results of the ILIAD Study (Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19), an investigator sponsored randomized trial of Peginterferon Lambda (Lambda) in outpatients with mild to moderate COVID-19 conducted at Toronto General Hospital, University Health Network in Toronto, Canada, the company said.

The main efficacy outcomes were viral load decline and the proportion of individuals with a negative nasopharyngeal swab for SARS-CoV-2 at Day 7. A total of 60 patients were randomized 1: 1 to a single subcutaneous dose of Lambda 180 mcg or normal saline placebo. Patients were followed for 14 days.

The SARS-CoV-2 RNA viral load decline from baseline was significantly greater in the Lambda group than in the placebo group from Day 5 onwards.

After controlling for baseline viral load, those treated with Lambda were 4.1-fold (95% CI 1.2-16.7, p=0.029) more likely to clear by Day 7 than those in the placebo arm.

For those with baseline viral load > 6 log copies/mL, the proportion negative at Day 7 in the Lambda group was 15 of 19 compared to 6 of 16 in the placebo group (p=0.013). This difference translated into a median time to clearance of 7 days with Lambda compared to 10 days in the placebo group (p=0.038).

Consistent with recently reported studies, there was no difference in time to clearance in patients with low baseline viral loads < 6 log copies/mL: 9 of 11 in the Lambda arm and 13 of 14 in the placebo arm were negative by Day 7 (p=0.40).

Across all patients, by Day 7, 24 of 30 patients in the Lambda group were negative compared to 19 of 30 in the placebo arm (p=0.15).

Participants with low viral loads also had milder symptoms at baseline with symptoms improving over time in both groups. Lambda was well-tolerated with few adverse events, which included minimal elevations of transaminases which self-resolved.

Lambda is a well-characterized, late-stage, first-in-class, type III interferon that stimulates immune responses that are critical for the development of host protection during viral infections.

Lambda targets type III IFN receptors which are distinct from the type I IFN receptors targeted by IFN alfa. Binding leads to activation of JAK-STAT signaling pathway and upregulation of numerous IFN-stimulated genes.

IFN lambda receptors are largely restricted to cells and tissues of epithelial origin, including respiratory epithelial cells.

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 the 'cytokine storm' from developing.

The ILIAD Study (Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19) is one of several international, investigator sponsored studies evaluating Lambda in COVID-19.

Eiger is developing Lambda as a monotherapy and in combination with lonafarnib boosted with ritonavir for the treatment of hepatitis delta virus infection.

Lambda has been administered to over 3,000 subjects in 19 clinical trials of HBV, HCV and HDV. Lambda is an investigational agent and not yet approved for any indication.

Eiger has received Orphan Designation by the US Food and Drug Administration and European Medicines Agency, and Fast Track and Breakthrough Therapy Designation by FDA for Lambda in HDV.

Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb (NYSE: BMY).

Eiger is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs.