Curis Trial for Emavusertib Put on Partial Clinical Hold by FDA
04 April 2022 - 9:48PM
Dow Jones News
By Chris Wack
Curis Inc. said Monday the U.S. Food and Drug Administration has
placed a partial clinical hold on a leukemia-drug study.
The Phase 1/2a study is for orally administered emavusertib as
monotherapy and in combination with azacitidine or venetoclax in
patients with relapsed or refractory acute myeloid leukemia or
high-risk myelodysplastic syndrome.
Curis said that while the partial hold is in place, no new
patients would be enrolled in the study, and current study
participants benefiting from treatment may continue to be treated
with emavusertib at doses of 300mg BID or lower.
With the partial hold, the FDA is requesting additional data
from the study, including data related to the death of a relapsed
or refractory acute myeloid leukemia patient who experienced, among
several conditions, rhabdomyolysis, which has previously been
identified as a dose-limiting toxicity of emavusertib.
The FDA is also requesting safety, efficacy, and other data,
including data related to rhabdomyolysis and the company's
determination of the recommended Phase 2 dose for emavusertib in
this study.
Curis expects to provide updated guidance on the timing of
discussing the potential for a rapid registrational path for
emavusertib with the FDA after the partial clinical hold is
resolved and the related impact on the trial can be determined.
While this partial hold does not affect a Phase 1/2 open-label
dose escalating clinical trial investigating emavusertib in
patients with B-cell malignancies, the company has decided to pause
enrollment of new patients in that study as well.
Curis shares were down 18%, to $2, in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
April 04, 2022 07:33 ET (11:33 GMT)
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