By Chris Wack

 

SpringWorks Therapeutics Inc. reported positive topline results from a placebo-controlled Phase 3 trial evaluating the efficacy, safety and tolerability of nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors.

The biopharmaceutical company said the trial met its primary endpoint of improving progression-free survival, demonstrating a statistically significant improvement for nirogacestat over placebo, with a 71% reduction in the risk of disease progression.

SpringWorks said the trial met all key secondary endpoints, with nirogacestat demonstrating statistically significant improvements as compared to placebo in objective response rate and patient-reported outcomes.

Nirogacestat was generally well tolerated with a manageable safety profile, it said.

SpringWorks plans to submit a new-drug application to the U.S. Food and Drug Administration in the second half of 2022, it said.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

May 24, 2022 07:13 ET (11:13 GMT)

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