Curis Resumes Enrollment In Monotherapy TakeAim Leukemia Study, Combo Phase Still Under Partial Hold

  • The FDA has notified Curis Inc CRIS to resume enrollment of additional patients in the monotherapy phase of the TakeAim Leukemia study of Emavusertib.
  • The FDA had placed partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies in April. 
  • Earlier this month, the FDA lifted the partial hold on the TakeAim Lymphoma study
  • The company has agreed to enroll at least nine additional patients at the 200mg dose level in the monotherapy dose-finding phase (Phase 1a) of the TakeAim Leukemia study.
  • The partial hold remains in place for the combination therapy phase (Phase 1b) and the study's expansion phase (Phase 2a) until Phase 1a is complete and the FDA approves proceeding to the next phases.
  • Before lifting the restriction, the FDA reviewed additional data related to the risk of rhabdomyolysis, a side effect associated with statins and cancer medications such as Odomzo and Cotellic. 
  • Rhabdomyolysis is associated with a breakdown of muscle tissue that releases a damaging protein into the blood.
  • Updated preliminary data from the TakeAim Leukemia study is expected in 2023.
  •  In addition, Curis is proactively discussing the clinical plans for emavusertib in leukemia, including alignment on optimal dose and development path, with the FDA's leukemia division.
  • Price Action: CRIS shares traded 1.79%lower at $1.10 premarket on the last check Tuesday.
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