Eiger BioPharmaceuticals: Promising COVID-19 Effort With Peginterferon Lambda Just Entering Clinical Trials
Summary
- Eiger BioPharmaceuticals has two main drug development efforts, lonafarnib for Progeria and Hepatitis D and Peginterferon lambda for Hepatitis D.
- Interferons have been explored as mediators of rapid, innate antiviral protection. In vitro, interferon lambda has shown potency against several coronaviruses.
- Eiger has just begun to investigate the use of Peginterferon Lambda in COVID-19, with the first patients having been dosed.
- Eiger has a market capitalization of $240 million. In Q1, the company recorded a loss of $15.2 million, and it exited with $77.6 million in cash and short term investments.
- Several published studies suggest that SARS-CoV-2 induces very weak expression of interferons in infected cells, which hampers the early innate immune response. Therefore, exogenous interferon may prove beneficial for treatment.
Eiger BioPharmaceuticals (NASDAQ:EIGR) is developing lonafarnib, an oral prenylation inhibitor, to treat Hepatitis D and Progeria. Hepatitis D is typically a superinfection on top of Hepatitis B, leading to a more severe form of the disease. It affects 15-20 million people worldwide, and there is no current therapy approved. In the US, lornafarnib has been granted orphan drug designation for this indication, and it has fast track status in combination with ritonavir. It is in Phase 3 clinical study. Lonafarnib is also being investigated to treat progeria,a very rare autosomal dominant, fatal, premature aging syndrome caused by a gene mutation. An NDA was submitted to the FDA in March, and the drug has been granted breakthrough Therapy Designation and Rare Pediatric Disease Designation.
Eiger is also pursuing the use of Peginterferon lambda, both as montherapy and as combination therapy with lonafarnib, to treat Hepatitis D. A Phase 2 monotherapy study has been completed, and end of treatment Phase 2 data on a combination study is slated for the EASL 2020 meeting in August.
Recently, Eiger began pursuing the use of Peginterferon lambda to treat COVID-19. A trial is underway in which 120 patients will be randomized 1:1 to a single subcutaneous dose of Lambda or saline placebo in order to evaluate viral shedding and symptom and hospitalization reduction in patients with mild COVID-19 for a 28 day period. It is important to recognize that most other therapies that seem promising are directed at moderately to critically ill hospitalized patients. The possibility of targeting less symptomatic patients is more valuable from a healthcare standpoint, and it addresses a much larger population. There have been several publications and studies that support the use of interferon in treating coronavirus. In a recent Journal of Experimental Medicine, Prokunia-Olsson et al. wrote that interferon administration can be used for prophylaxis or early therapy, predicated on the principle of compensating for activity that might be blocked by a virus. In vitro, interferon lambda has shown potency against SARS-CoV1 and MERS-CoV. Furthermore, the absence of pro-inflammatory effects in the lungs is one of the most important advantages for the specific advantage of interferon lambda over Type 1 interferons as a treatment option for COVID-19. Protection could therefore be provided to healthcare workers and others at high risk, in addition to those patients showing no signs of a lung inflammatory reaction. Thomas O'Brien of the NIH and others have suggested that the weak induction of interferon expression by SARS-CoV-2 supports clinical trials of interferon lambda to treat early COVID-19. They note that interferons play a crucial role in the immune response to viral infections, and that the interferon lambda receptor is largely restricted to cells and tissues of epithelial cells, including respiratory epithelial cells. Furthermore, Peginterferon lambda has been tested in over 3,000 human subjects in chronic Hepatitis C, and it produces fewer side effects than Peginterferon alpha.
Given that there are an estimated 100,000 people in the US and 200,000 in the EU with Hepatitis D, which progresses more than twice as fast to cirrhosis as compared to Hepatitis B alone, Eiger estimates the peak year market opportunity to exceed $1 billion for pharmacotherapy. Therefore, successful development of lonafarnib or Peginterferon lambda for this indication would more than justify the current stock price. The opportunity in COVID-19, while early, seems supported by previous investigations. Furthermore, it is important to realize that Peginterferon lambda is targeting a patient population for which neither remdesivir nor the IL-6 inhibitors is suited. I am adding Eiger BioPharmaceuticals to my "coronavirus portfolio". I note that I have previously written that I expect the downslope of new daily cases in the US to be very gradual, given increased testing and the relaxation of restrictions. In the US, there are an average of 25,000 new cases per day, and I forecast this to decline to under 10,000 by fall, assuming that Americans remain vigilant with social distancing and mask wearing.
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