Sanofi's Phase 3 Study of Rilzabrutinib Didn't Meet Primary, Secondary Endpoints
September 09 2021 - 1:45AM
Dow Jones News
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)
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