Curis Trial for Emavusertib Put on Partial Clinical Hold by FDA

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 [e-mail]

(END) Dow Jones Newswires

April 04, 2022 07:33 ET (11:33 GMT)

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