By Denny Jacob

Scholar Rock Holding said the Food and Drug Administration cleared its investigational new drug application for its Phase 2 trial of apitegromab to treat obesity in patients taking a GLP-1 receptor agonist.

The late-stage biopharmaceutical company said trial initiation is on track for mid-2024 and data from the trial is expected in mid-2025.

In parallel, Scholar Rock is developing SRK-439 also to treat obesity. It plans to file an investigational new drug application for SRK-439 in 2025.

"The FDA's acceptance of our IND application to study apitegromab in obesity allows us to assess the effect of our highly selective myostatin inhibitor on preserving lean muscle mass, and safety and tolerability of our approach when combined with a GLP-1 RA," said Chief Executive Jay Backstrom.

Write to Denny Jacob at denny.jacob@wsj.com

(END) Dow Jones Newswires

January 23, 2024 08:47 ET (13:47 GMT)

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