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Eiger Down on Disappointing Results From Coronavirus Study

Zacks Equity Research
·3 min read

Shares of late-stage Eiger BioPharmaceuticals, Inc. EIGR were down 19.5% after it announced dismal results from an investigator-sponsored study on pipeline candidate, peginterferon lambda-1a (lambda), in outpatients with mild and uncomplicated COVID-19.

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

A total of 120 patients were randomized in the ratio of 1:1 to a single subcutaneous dose of lambda or normal saline placebo. Patients were followed for 28 days.

The primary endpoint of the study was the 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 the duration of symptoms and hospitalization in patients with mild COVID-19.  

However, lambda did not show any difference in duration of SARS-CoV-2 viral shedding and time to symptom resolution when compared with placebo. The median time to cessation of viral shedding in both groups was seven days. Results further showed that Lambda was well tolerated with few adverse events, which included elevated transaminases which self-resolved.

Eiger’s stock has slumped 46.5% so far this year against the industry’s growth of 2.3%.

 

Nevertheless, the candidate is being evaluated in four 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 BMY. 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, 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 MRK for lonafarnib.

The company earlier generated positive results from two phase II studies in HDV-infected patients and has concurrence with the FDA and the EMA on a single, phase III study of lambda monotherapy in patients infected with chronic HDV.

Eiger currently carries a Zacks Rank #3 (Hold). Horizon Therapeutics HZNP is a better-ranked stock in the biotech sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Horizon’s earnings per share estimates have increased 3 cents in the past seven days for 2020 and 6 cents for 2021.

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Merck Co., Inc. (MRK) : Free Stock Analysis Report
 
Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report
 
Horizon Therapeutics Public Limited Company (HZNP) : Free Stock Analysis Report
 
Eiger BioPharmaceuticals, Inc. (EIGR) : Free Stock Analysis Report
 
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Zacks Investment Research