Shares of Regeneron Pharmaceuticals, Inc. REGN gained after it announced the initiation of late-stage studies on experimental coronavirus candidate, REGN-COV2.
REGN-COV2 is Regeneron's investigational double-antibody cocktail, which is being evaluated both for the treatment and prevention of COVID-19.
A phase III study will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate).
The study is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The phase III prevention trial is being conducted at approximately 100 sites and expected to enroll 2,000 patients in the United States. The trial will assess SARS-CoV-2 infection status. The two phase II/III treatment trials in hospitalized (estimated enrollment =1,850) and non-hospitalized (estimated enrollment =1,050) patients are planned to be conducted at approximately 150 sites in the United States, Brazil, Mexico and Chile, and will evaluate virologic and clinical endpoints, with preliminary data expected later this summer.
The decision to initiate these late-stage studies followed a positive review from the Independent Data Monitoring Committee (“IDMC”) of phase I safety results on REGN-COV2 in an initial cohort of 30 hospitalized and non-hospitalized patients with COVID-19.
The candidate is also being evaluated in phase II/III studies to treat hospitalized and non-hospitalized (or "ambulatory") patients with COVID-19.
We note that Regeneron evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune mice, which have been genetically-modified to have a human immune system, as well as gathered antibodies isolated from humans who have recovered from COVID-19. The company then selected the two most potent, non-competing and virus-neutralizing antibodies to create REGN-COV2.
Investors cheered the news after last week’s disappointment when Regeneron and partner Sanofi SNY announced that the phase III study evaluating their IL-6 inhibitor, Kevzara (sarilumab), in hospitalized patients with severe COVID-19 failed to meet its primary endpoint. The drug also showed negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline. The study was stopped following the recommendation of IDMC based on these results.
Regeneron’s share price has surged 72.1% in the year so far compared with 11.7% growth for the industry.
The company 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.
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.
The FDA has granted Gilead’s remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19, given the severity of the pandemic.
Last month, Eli Lilly and Company LLY announced that the first patient has been dosed in a phase I study of LY-CoV555, the lead antibody designed to fight COVID-19.
Regeneron currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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