SNY Sanofi

By Pietro Lombardi

Sanofi SA and GlaxoSmithKline PLC are enrolling more than 400 people to start the Phase 1/2 clinical trial of their Covid-19 vaccine candidate, with a goal of moving to Phase 3 by the end of the year and requesting regulatory approval in the first half of next year.

The French pharmaceutical major said Thursday that the companies are targeting the production of up to a billion doses next year.

Preclinical studies were promising, it said.

The Phase 1/2 trial is a randomized, double blind and placebo-controlled trial which will evaluate the safety, tolerability and immune response of the Covid-19 vaccine candidate. First results are expected in early December, which would allow the companies to kick off a Phase 3 trial in December.

For the current trials, 440 people are being enrolled.

The U.S. Department of Health and Human Services is supporting the development of the vaccine, including with funding.

Write to Pietro Lombardi at pietro.lombardi@dowjones.com; @pietrolombard10

(END) Dow Jones Newswires

September 03, 2020 01:46 ET (05:46 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.