Regeneron Advances Covid-19 Drug Into Later-Stage Testing

By Joseph Walker 

Regeneron Pharmaceuticals Inc. said Monday it is starting later-stage studies of its experimental Covid-19 drug, a quick move into testing that could establish whether the drug can be used for treatment and prevention.

Regeneron's drug, REGN-COV2, is among the most advanced in a class of medicines known as monoclonal antibodies being developed to treat Covd-19. Eli Lilly & Co. was the first company to start human safety studies of two separate antibody drugs, followed by Regeneron.

Regeneron began experiments to design antibodies for Covid-19 in early February, and started initial human studies four months later, in June. The drug combines an antibody derived from mice with genetically engineered immune systems and an antibody taken from a patient who recovered from Covid-19.

Regeneron said its drug's performance in a safety study of 30 hospitalized and nonhospitalized Covid-19 patients received a positive review from an independent data-monitoring committee.

The company is now beginning larger trials of the drug as a treatment for infected patients and to provide temporary protection against new infections.

The treatment studies, combining the final two stages, or phases 2 and 3, of testing, will evaluate REGN-COV2 in hospitalized and nonhospitalized patients.

The study of hospitalized patients is expected to enroll 1,850 study subjects, and the study of nonhospitalized is expected to enroll 1,050 subjects, the company said.

Preliminary study data from the two studies of infected patients are expected later this summer, the company said.

In addition, Regeneron and the National Institute of Allergy and Infectious Diseases are starting a phase 3 study of REGN-COV2 to provide temporary protection against new infections in people who have had close exposure to Covid-19 patients, such as housemates.

Monoclonal antibodies are designed by pharmaceutical companies to mimic human antibodies that people naturally develop to neutralize foreign pathogens such as viruses and bacteria. The drugs have previously been shown to help prevent deaths from the Ebola virus.

Write to Joseph Walker at [e-mail]

(END) Dow Jones Newswires

July 06, 2020 12:25 ET (16:25 GMT)

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