Imara Gets FDA Approval for Tovinontrine IND Application
January 25 2022 - 8:07AM
Dow Jones News
By Chris Wack
Imara Inc. said the U.S. Food and Drug Administration cleared
the investigational new-drug application for tovinontrine IMR-687
to begin clinical development for the treatment of heart failure
with preserved ejection fraction.
The biopharmaceutical company said it plans to initiate a Phase
2 trial in the second quarter of 2022 to evaluate tovinontrine in
patients 45 years of age or older with persistent HFpEF
symptoms.
Imara said it expects to begin the Phase 2 trial in the second
quarter of 2022, with a design that focuses on identifying HFpEF
patients with high PDE9 expression.
Imara's Phase 2 HFpEF trial will be a randomized,
placebo-controlled study of 170 patients 45 years of age or older
with enriched PDE9 expression and persistent symptoms of HFpEF.
Trial subjects will be dosed for 16 weeks, the company said.
The primary endpoint will be change in N-terminal pro b-type
natriuretic peptide, or NT-proBNP, with secondary endpoints that
include safety and tolerability, the company said.
Exploratory measures include a clinical composite score,
six-minute walk test and evaluation of cardiac structure and
function, the company said.
Imara shares were up 5% to $1.65 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 25, 2022 07:52 ET (12:52 GMT)
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