Amarin announced on Friday that Kaiser Permanente Northern California (KPNC) is initiating a trial to study the potential of its lead product Vascepa to be used as a treatment to prevent or reduce the risk of complications from viral respiratory illnesses such as COVID-19 in older adults with heart disease.
Biotech Amarin (AMRN) said that that the MITIGATE COVID-19 study, will test the effects of Vascepa on viral upper respiratory infection (URI) rates and clinical outcomes, especially involving acute respiratory SARS-CoV-2 infection, in adults with atherosclerotic cardiovascular disease (ASCVD) who are at elevated risk of experiencing moderate to severe COVID-19.
The trial will involve 1500 US patients aged 50 years or older with ASCVD and no prior history of confirmed COVID-19, who will receive 4 grams per day 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. A control group will consist of 15,000 adults meeting the same eligibility criteria who will be passively followed through KPNC’s electronic health record system for outcome ascertainment.
“Most prior clinical trials for COVID-19 have focused on treating patients hospitalized for moderate or severe COVID-19 with experimental agents,” said KPNC’s Andrew Ambrosy. “MITIGATE COVID-19 is novel in that we will study the effects of pre-treatment with IPE, an FDA-approved therapy for primary and secondary prevention with putative anti-inflammatory as well as antiviral properties, in high-risk outpatients with ASCVD on subsequent risk of viral URI-related morbidity and mortality.”
Amarin’s lead drug Vascepa was initially launched in the US in 2013 as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. A new, cardiovascular risk indication for the fish-oil derivative was approved by the FDA in December 2019 based on the results of the landmark Reduce-It trial.
Year-to-date shares in Amarin have plunged 67%, as the biopharma’s Vascepa suffered from a sales decline with many patients remaining at home, as well as many physician offices closed amid the coronavirus pandemic. In addition, the company is currently appealing to the US Court of Appeals a March 2020 patent invalidity ruling in favor of generic companies, Hikma Pharmaceuticals USA Inc. and Dr. Reddy’s Laboratories, Inc.
H.C. Wainwright’s Andrew Fein reiterated a Buy rating on the stock put his price target under review as the analyst cautions that “Amarin’s elephant in the room continues to be the Vascepa patent litigation”. (See Amarin stock analysis on TipRanks)
“We believe physician and patient education on the benefits of Vascepa remains paramount for widespread adoption, and our concern is that this educational and promotional push could be greatly reduced or eliminated with introduction of a non-branded generic competitor,” Fein wrote in a note to investors. “With the potential future ruling allowing for the launch of generic Vascepa, little is accomplished by way of generic entrants actually being capable of launching at scale.
Overall, Wall Street analysts retain a cautiously optimistic Moderate Buy outlook on the stock. This breaks down into 4 recent Buy ratings versus 4 Hold ratings. Meanwhile the average analyst price target of $14.17 translates into 102% upside potential.
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