Imara Gets FDA Approval for Tovinontrine IND Application

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 [e-mail]

(END) Dow Jones Newswires

January 25, 2022 07:52 ET (12:52 GMT)

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