Scholar Rock Says FDA Clears Application for Trial of Obesity Treatment Apitegromab
January 23 2024 - 9:02AM
Dow Jones News
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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