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Sanofi's Phase 3 Study of Rilzabrutinib Didn't Meet Primary, Secondary Endpoints

09/09/2021 6:45am

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   By Mauro Orru 
 

Sanofi SA said Thursday that a Phase 3 study assessing rilzabrutinib for the treatment of pemphigus--a group of potentially life-threatening disorders characterized by blisters and ulceration affecting the skin and mucous membranes--didn't meet its primary or key secondary endpoints.

The French pharmaceutical major said the primary endpoint was complete remission from weeks 29 to 37 with minimal doses of corticosteroids, with results showing that the proportion of patients meeting the primary endpoint wasn't much different from placebo.

However, Sanofi said rilzabrutinib's safety profile was still consistent with previous results and that no new safety signals were identified.

"While these results are disappointing, we believe the rilzabrutinib clinical program holds great potential to address the unmet treatment needs of people living with immune-mediated diseases," said Naimish Patel, head of global development for immunology and inflammation.

"We are committed to investigating rilzabrutinib further and progressing our clinical programs forward to deliver new treatment options for patients," Mr. Patel said.

 

Write to Mauro Orru at mauro.orru@wsj.com; @MauroOrru94

 

(END) Dow Jones Newswires

September 09, 2021 01:30 ET (05:30 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.

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