Amarin Corp.: Whether Vascepa Is A COVID-19 Play – Seeking Alpha

Amarin Corporation's (AMRN) flagship product, Vascepa, is not an antiviral, steroid, antibody, or vaccine, but investors need to be aware of its potential to be a COVID-19 therapeutic. Vascepa (icosapent ethyl) is an FDA approved as an adjunct to maximally tolerated statin therapy to diminish the risk of cardiovascular events in certain adults with high triglyceride levels of 150 mg/dc or higher and other cardiovascular risk factors and to reduce severely elevated levels of triglycerides of 500 mg/dl or higher. Vascepa is expected to help reduce the risk of heart attack, stroke, and other symptoms of cardiovascular disease. So, if Vascepa is a cardiac drughow is it supposed to help combat COVID-19? New data shows an increase in morbidity and mortality in COVID-19 patients with cardiac ailments. In addition, some researchers have discovered the long-lasting impact of COVID-19 on the heart and its function. Therefore, I believe Vascepa could be a critical component to the COVID-19 treatment paradigm that could be implemented at every stage of the disease, including recovery. Luckily, investigators have already started to investigate Vascepa's ability to contribute to the war effort against COVID-19. If these studies are successful, Vascepa could be accepted as a solution to a broad range of challenges caused by COVID-19. As a result, I believe there is potential for AMRN to attract some attention from the market in the near future as investors continue to search for latent COVID-19 plays.

(Image Source: AMRN)

I intend to present a case for Vascepa's potential use in the COVID-19 paradigm and why investors should consider AMRN in their speculative portfolio.

As I mentioned in my introduction, some data has revealed that patients with established cardiovascular diseases such as hypertension, coronary artery disease, and heart failure are at an increased risk for morbidity and mortality from COVID-19. One report on 39 autopsies of patients with COVID-19 who died of pneumonia showed 24 of those 39 patients had the virus in the heart. What is more, 16 of those 24 patients had a viral load of more than 1000 copies per microgram of RNA in the heart, with evidence of active viral replication.

In another study of 100 recovering COVID-19 patients, 78% had perceptible cardiac participation and 60% had myocardial inflammation. The authors postulated that COVID-19 could have a long-term impact on the heart's left ventricle, inflammation, new-onset heart failure, acute myocarditis, microvascular clot formation, and other chronic cardiovascular complications.

Based on these studies, we can say that there is evidence that COVID-19 is able to infect the heart, which could cause an increase in morbidity and/or mortality. Furthermore, we can say that the virus' impact on the cardiovascular system could last for a prolonged period of time.

Back in May, Amarin announced that a group of investigators was preparing to match Vascepa against inflammation caused by COVID-19. The trial's primary endpoint is the effect of VASCEPA vs. Standard-Of-Care on "high-sensitivity C-reactive protein levels from baseline to 14 days in adults with a COVID-19-positive diagnosis." Into the bargain, the study will record Vascepa's impact on the rate and severity of infection, which includes alterations in D-dimer levels, erythrocyte sedimentation rates, complete blood counts, serum albumin levels, neutrophil-to-lymphocyte ratio, and systemic immune-inflammation index. All these endpoints and inflammatory measurements will be recorded two weeks after the initial visit. Unfortunately, the study is still recruiting and is expected to be completed near year-end of this year.

Amarin recently publicized another investigator-initiated trial of Vascepa's impact on viral upper respiratory infection "URI" rates and clinical outcomes for COVID-19 patients with "established atherosclerotic cardiovascular disease "ASCVD" who are at elevated risk of experiencing moderate to severe COVID-19." Kaiser Permanente Northern California "KPNC" will be conducting the study with "1500 U.S. patients aged 50 years or older with established ASCVD and no prior history of confirmed COVID-19." Subjects will receive 4g daily doses of Vascepa for a minimum of 6 months. The co-primary study endpoints are "the rate of moderate to severe laboratory-confirmed viral URI, including COVID-19 and influenza, prompting urgent care encounters, emergency department visits, or hospitalization and the worst clinical status due to a laboratory-confirmed viral URI based on an ordinal scale taking hospitalization, death, supplemental oxygen, and other clinical factors into account." The control will consist of 15K patients with the same criteria.

Together, these studies should give us some insight into whether Vascepa is able to reduce inflammation and improve COVID-19 patient outcomes.

Vascepa is comprised of eicosapentaenoic acid "EPA", which has a variety of clinical effects and has been studied in a plethora of indications. However, I was surprised to see the investigators and Amarin testing Vascepa for its potential antiviral/antimicrobial effects. While performing some research, I discovered that EPA has shown some ability to inactivate enveloped viruses such as COVID-19, SARS, and MERS. EPA facilitates lipoxins, resolvins, protectins, and maresins which suppress inflammation and augment phagocytosis of macrophages and decrease the microbial load. So, there is some evidence that Vascepa could enhance resistance and recovery from COVID-19.

Admittedly, I wasn't aware of EPA's antiviral/antimicrobial effects, so I am struggling to determine how I should classify Vascepa in COVID-19. Is it a prophylactic? Is it therapeutic? Who will get Vascepa? It appears Amarin and investigators are expecting Vascepa to be helpful at every stage of the infection, but we need to determine where Vascepa's sweet spot is.

Certainly, I would be awestruck to see that Vascepa was able to have a substantial impact on the virus's ability to replicate or was able to drastically reduce the inflammation and tissue damage. I don't expect Vacepa to outperform antivirals and steroids as the preferred treatment option, but perhaps Vascepa will be able to demonstrate strong enough results to justify using it in mild-to-moderate cases and possibly as an adjunct therapy in severe patients to help reduce the risk of a cardiac event. Unlike many antivirals and steroids, Vascepa's safety profile should allow it to be employed at various stages of infection and for an extended period of time.

Personally, I was expecting Vascepa to be deployed to COVID-19 patients who are recovering from the infection and will be at high risk of a cardiac event or already have cardiovascular disease. Admittedly, that is quite obvious considering Vascepa's current labels, but I believe there will be an opportunity for patients who have experienced some damage in their cardiovascular system, which looks to be a significant proportion of hospitalized patients (78% in one study). Obviously, if a COVID-19 patient experiences lung and cardiac damage from the viral infection, they will be at a higher risk for a serious cardiac event. Yes, we want to see patients survive the infection but we may have millions of patients around the world who may have permanent damage to their cardiovascular system. This is where I see Vascepa's stepping in as a unique therapeutic option that can be employed to help a patient fully-recover from a battle with COVID-19. At this point in time, I can't find any other prospective COVID-19 candidate that offers these potential benefits and capabilities.

Unlike other potential COVID-19 therapeutics, Vascepa doesn't appear to be getting the same acknowledgment and consideration as other candidates are receiving. Indeed, an omega-3 drug is not as obvious as an antiviral or monoclonal antibody, but it is one of only a few branded drugs that are already FDA approved and has a legitimate mechanism of action to help COVID-19 patients on some level. What is more, the potential market for Vascepa could grow by millions because of the number of COVID-19 patients that could require daily dosing for an extended period of time, or perhaps the rest of their life.

Figure 1: AMRN Daily Chart (Source: Trendspider)

However, the market continues to punish AMRN's share price due to its ongoing patent battle with generic drug companies. Yes, generic encroachment has a devastating impact on the drug's peak sales and will erode the market share. As a result, investors looking to invest in AMRN for a "COVID Play" should see it as a highly speculative investment that is being dictated by ongoing litigation headlines rather than data readouts.

Disclosure: I am/we are long AMRN. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Read the original:
Amarin Corp.: Whether Vascepa Is A COVID-19 Play - Seeking Alpha