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Regeneron Pharmaceuticals, Inc. REGN has initiated the first study on its experimental dual antibody cocktail, REGN-COV2, for the prevention and treatment of COVID-19.
This program consists of four separate study populations — hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected patients in groups that are at high risk of exposure (such as healthcare workers or first responders) and uninfected patients with close exposure to a COVID-19 patient (such as the patient's housemate). The placebo-controlled studies will be conducted at multiple sites.
The first two adaptive phase I/II/III studies are evaluating REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalized and non-hospitalized patients with COVID-19. The phase I portion will focus on virologic and safety endpoints while the phase II portion will focus on virologic and clinical endpoints. Data from the phase I and phase II studies will be used to refine the endpoints and determine size for the phase III studies.
The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines.
We note that the Biomedical Advanced Research and Development Authority (BARDA) partly funded REGN-COV2's preclinical development and preclinical/clinical manufacturing.
A positive outcome will significantly boost the growth prospects of the company. Regeneron’s share price has surged 64.9% in the year so far compared with 4.4% growth for the industry.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is running a race against time to come up with treatments and vaccines to cure the contagion. Given the alarming levels of spread and severity, quite a few biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective in treating the infected patients.
Regeneron has had a great year so far, soaring high and pioneering the race for a possible coronavirus treatment along with other biotechs like Gilead Sciences, Inc. GILD.
Gilead’s remdesivir is leading the race for a possible treatment of this deadly virus. The company recently reported mixed results from a late-stage study on investigational antiviral remdesivir in hospitalized patients with moderate COVID-19 pneumonia. It was recently granted regulatory approval in Japan under the brand name, Veklury, as a treatment for SARS-CoV-2 infection. The approval came under an exceptional approval pathway.