Eiger BioPharmaceuticals, Inc
were up 17.5% after it reported positive results from an investigator-sponsored randomized study, ILIAD (Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19), of peginterferon lambda-1a (lambda) in outpatients with mild-to-moderate COVID-19.
Lambda is a well-characterized, late-stage, first-in-class, type III interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections. The ILIAD study is one of the several international, investigator-sponsored studies evaluating lambda in COVID-19.
The study enrolled 60 patients who were randomized 1:1 to a single subcutaneous dose of lambda 180 mcg or normal saline placebo. Patients were followed for 14 days. The main efficacy outcomes were viral load decline and the proportion of individuals with a negative nasopharyngeal swab for SARS-CoV-2 on day 7.
The study was conducted at Toronto General Hospital, University Health Network in Toronto, Canada.
Results showed that the SARS-CoV-2 RNA viral load decline from baseline was significantly greater in the lambda group as compared to the placebo group from day 5 onward. After controlling for baseline viral load, those treated with lambda were 4.1-fold more likely to clear by day 7 than those in the placebo arm. For those with higher baseline viral load, the proportion of patients negative at day 7 in the Lambda group was 15 of 19 compared to 6 of 16 in the placebo group.
There was not much difference in time to clearance in patients with low baseline viral loads in both arms. Participants with low viral loads also had milder symptoms at baseline, with symptoms improving over time in both groups.
All lambda-treated patients were below the infectivity threshold by day 7.
The news was well received by the investors, as the company had reported disappointing results on the candidate in outpatients with mild and uncomplicated COVID-19, last month.
Eiger’s stock has slumped 32% so far this year compared with the
’s decline of 0.2%.
Nevertheless, the candidate is being evaluated in various ongoing investigator-sponsored studies in hospitalized patients with more advanced COVID-19 along with a prophylaxis study of exposed or at-risk patients.
We note that Eiger in-licensed world-wide rights to Lambda from Bristol-Myers Squibb
. Lambda is in late-stage development for the treatment of Hepatitis Delta Virus (HDV), the most severe form of human viral hepatitis.
Eiger is developing two complementary treatments for HDV. Its lead candidate is lonafarnib, a first-in-class prenylation inhibitor. The candidate is being evaluated in a phase III study boosted with antiretroviral ritonavir for the treatment of HDV. The company is also developing lonafarnib monotherapy for the treatment of Progeria and Progeroid Laminopathies, which are ultra-rare and rapidly fatal genetic conditions of accelerated aging in children. In March 2020, it submitted a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the same. The FDA has set a target action date of Nov 20, 2020. A tentative approval will be a significant boost for the company. It has a license agreement with Merck
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of the spread and severity of the pandemic, quite a few biotechs are developing antibodies for the same.
submitted a request to the FDA for an Emergency Use Authorization (EUA) for its antibody treatment, REGN-COV2, for COVID-19.
Eiger currently carries a Zacks Rank #2 (Buy). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
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