Incyte announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU). The decision was made following the observation of certain in vivo preclinical toxicology findings.
These data have been shared with the U.S. Food and Drug Administration (FDA) and Incyte will work closely with the FDA to determine next steps.
Enrollment in the other INCB000262 proof-of-concept studies is complete and data from all clinical studies will help inform its future development and guide the potential development of back-up molecules.
In addition, data from the Phase 2 study evaluating MRGPRX4 (INCB000547) in cholestatic pruritus (CP) does not support further development.
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