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|Item 8.01.|| |
On October 15, 2020, Eiger BioPharmaceuticals, Inc. (the “Company”) announced results of the ILIAD Study (Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19), an investigator sponsored randomized controlled study of Peginterferon Lambda-1a (“Lambda”) in outpatients with mild COVID-19 conducted at Toronto General Hospital, University Health Network in Toronto, Canada.
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 (79%) compared to 6 of 16 (38%) 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: 13 of 14 (93%) in the placebo arm and 9 of 11 (82%) in the Lambda arm were negative by Day 7 (p=0.40). Across all patients, by Day 7, 24 of 30 patients (80%) in the Lambda group were negative compared to 19 of 30 (63%) 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.
In September 2020, the Company announced results of another investigator sponsored study of Lambda in outpatients with mild and uncomplicated COVID-19 co-led by Stanford University School of Medicine researchers Upinder Singh, MD, Professor of Medicine and Infectious Diseases and Geographic Medicine and Microbiology and Immunology, and Prasanna Jagannathan, MD, Assistant Professor of Medicine and Infectious Diseases.
The primary endpoint was duration of viral shedding, determined by time to first of two consecutive negative tests for SARS-CoV-2 by qRT-PCR. The secondary endpoint was reducing duration of symptoms and hospitalization in patients with mild COVID-19. A total of 120 patients were randomized 1:1 to a single subcutaneous dose of Lambda or normal saline placebo. Patients were followed for 28 days.
No difference was demonstrated in duration of SARS-CoV-2 viral shedding and time to symptom resolution when compared with placebo. Median time to cessation of viral shedding in both groups was 7 days. Lambda was well-tolerated with few adverse events, which included elevated transaminases which self-resolved.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Eiger BioPharmaceuticals, Inc.|
|Dated: October 15, 2020|
|Chief Financial Officer|