Will Eiger’s Zokinvy Make History To Become First-ever Progeria Treatment?

Shares of Eiger BioPharmaceuticals Inc. (EIGR) are down 44 percent from their 52-week high of $15.82, recorded on December 26, 2019, and trade around $8.00.

Eiger is a late-stage biopharmaceutical company developing first-in-class drugs for serious rare and ultra-rare diseases, for which no approved therapies exist.

The company’s lead drug candidate is Zokinvy, known generically as Lonafarnib, for the treatment of Progeria and Progeroid Laminopathies.

Progeria and Progeroid Laminopathies are serious, ultra-rare diseases characterized by premature and accelerated aging in children. It is estimated that globally, there are 400 children with Progeria and 400 children with Progeroid Laminopathies. There is no known cure and the average life expectancy for the untreated children is around 14 years.

Progeria is caused by a point mutation in a single gene called lamin A. This mutated gene produces an abnormal form of the lamin A protein called progerin. Progeroid Laminopathies are caused by a constellation of mutations in the lamin A and/or Zmpste24 genes yielding farnesylated proteins that are distinct from progerin.

Eiger’s Zokinvy, which is designed to work by blocking the farnesylation of the aberrant protein, progerin, is under FDA review, with a decision expected on November 20, 2020. The drug candidate is also being reviewed by the European Medicines Agency.

Lonafarnib, co-dosed with Ritonavir, is being evaluated as a potential treatment of Hepatitis Delta Virus in a phase III trial, dubbed D-LIVR. Enrollment in this study is expected to be completed in 2021.

Hepatitis Delta Virus (HDV) infection, caused by Hepatitis Delta Virus, is the most severe form of viral hepatitis, and it occurs only as a co-infection in individuals infected with Hepatitis B Virus. It leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure.

Lonafarnib boosted with Ritonavir in combination with Lambda has been successfully studied in a phase IIa study in adult patients with chronic HDV, dubbed LIFT. According to the company, 96% of patients in the study achieved the primary endpoint of more than 2 Log decline in HDV RNA.

Eiger is developing Lambda as a monotherapy and in combination with Lonafarnib. The company licensed worldwide rights to Lambda from Bristol-Myers Squibb (BMY) in April 2016.

In an investigator-sponsored randomized trial which evaluated subcutaneous dose of Lambda against normal saline placebo in outpatients with mild to moderate COVID-19, conducted at Toronto General Hospital, dubbed ILIAD, Lambda significantly accelerated viral decline. All Lambda-treated patients were below the infectivity threshold by Day 7, according to the results reported last month.

In another investigator-sponsored study of Lambda in outpatients with mild and uncomplicated COVID-19, co-led by Stanford University School of Medicine, there was no difference in duration of SARS-CoV-2 viral shedding and time to symptom resolution when compared with placebo. The results of this study were reported in September.

Four more investigator-sponsored studies of Lambda in hospitalized patients with more advanced COVID-19, as well as the prophylaxis study of exposed or at-risk patients are ongoing.

Cash & Financials:

In the second quarter ended June 30, 2020, the net loss narrowed to $15.3 million or $0.60 per share from $17.5 million or $0.75 per share in the year-ago quarter.

The company ended the second quarter of 2020 with cash, cash equivalents, and short-term investments of $90.8 million.

EIGR has traded in a range of $4.55 to $15.82 in the last 1 year. The stock closed Friday’s trading at $8.88, down 1.11%.

Source: Read Full Article