BioPharma

Regeneron starts late-stage trials of antiviral antibody cocktail in Covid-19

The company also said that the Phase III study of the autoimmune disease drug Kevzara that it was running with Sanofi failed to meet either its primary or key secondary endpoints among critically ill Covid-19 patients.

A company that developed an antiviral cocktail therapy for treating Covid-19 has moved the treatment into late-stage clinical trials, just days after announcing the failure of its study of a drug it already markets for treating symptoms associated with Covid-19-related inflammation.

Tarrytown, New York-based Regeneron Pharmaceuticals said Monday that it and the National Institute of Allergy and Infectious Diseases had started a Phase III study of REGN-COV2, which consists of two monoclonal antibodies, as a prevention against Covid-19 in people who have had exposure to a patient with the disease, such as housemates. The company also started the Phase II/III portion of its two adaptive Phase I/II/III studies of REGN-COV2 in patients with Covid-19, including those who are hospitalized and those who are not.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

The Phase III study is taking place at about 100 sites in the U.S. and is expected to enroll 2,000 participants, while the studies in infected patients are anticipated to enroll 1,850 who are hospitalized and 1,050 who are not, in the U.S., Brazil, Mexico and Chile. Preliminary data from the latter two studies are expected later this summer, Regeneron said.

Shares of Regeneron rose 2% on the Nasdaq when markets opened Monday. The prevention study was posted on ClinicalTrials.gov last Tuesday, while the studies in hospitalized and non-hospitalized patients were posted on June 11.

“We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat Covid-19 infections, even in the midst of an ongoing global pandemic,” Regeneron President George Yancopoulos said in a statement. “We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an antiviral antibody cocktail that could be available much sooner than a vaccine.”

In a note to investors Monday, Cowen analyst Yaron Werber wrote that Regeneron’s two-antibody approach is more promising because it targets two non-competitive areas of the SARS-CoV-2 virus’ spike protein. In addition, he wrote, using two antibodies is better than using one because it not only prevents infection, but prevents viral escape.

The news follows the announcement on Thursday that the Phase III study Regeneron was running with French drugmaker Sanofi of Kevzara (sarilumab) among Covid-19 patients on ventilators did not meet its primary or key secondary endpoints. Unlike REGN-COV2 and Gilead Sciences’ remdesivir, Kevzara was among a large number of drugs being explored in Covid-19 patients as a treatment for the immune system overreaction associated with the disease’s most dangerous symptoms, including respiratory problems. The study compared Kevzara at 400mg added to best supportive care against best supportive care and placebo.

Although the data showed minor positive trends among critically ill patients who were mechanically ventilated at baseline, they did not show statistical significance, while the trend among critically ill patients who were not ventilated was negative. Moreover, patients in the Kevzara group showed somewhat higher rates of multi-organ dysfunction syndrome and low blood pressure.

Photo: Centers for Disease Control and Prevention