Prime Medicine Gets FDA Clearance for PM359 IND Application
By Chris Wack
Prime Medicine said that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for PM359 for the treatment of chronic granulomatous disease.
The biotechnology company said the clearance enables it to initiate its global Phase 1/2 clinical trial in the U.S.
The Phase 1/2 clinical trial is a multinational, first-in-human trial designed to assess the safety, biological activity and preliminary efficacy of PM359 in adult and pediatric study participants. Initial study participants will be adults with stable disease.
If safety and biological activity are demonstrated in this cohort, the study will enroll participants with active infection or severe inflammation as well as adolescent and pediatric participants.
Prime Medicine expects to report initial clinical data from the study in 2025.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
April 29, 2024 08:06 ET (12:06 GMT)
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