Protagonist Drug Studies Placed on FDA Hold
September 17 2021 - 7:51AM
Dow Jones News
By Matt Grossman
Protagonist Therapeutics Inc.'s clinical studies for its
rusfertide drug have been placed on a clinical hold by the U.S.
Food and Drug Administration because of a recent finding in a
mouse-model study, the company said Friday.
Benign and malignant skin tumors were observed in the
mouse-model study, Protagonist said.
Dosing of patients has been put on hold, the Newark,
Calif.-based pharmaceutical company said. Rusfertide was being
tested in three Phase 2 trials, to treat polycthemia vera--a type
of blood caner--and hereditary hemochromatosis, or iron
overload.
Protagonist said it will work with the FDA to make any necessary
updates to study protocols.
Write to Matt Grossman at matt.grossman@wsj.com
(END) Dow Jones Newswires
September 17, 2021 07:36 ET (11:36 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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