C2E2
Development Status
IND-enabling tasks have been completed for C2E2, Capture’s lead development candidate, including pre-formulation characterization of the drug molecule, extensive safety-toxicology assessments, and initial efficacy studies in animal models. Capture submitted an IND application to the FDA in May of 2017, and is making plans to initiate first-in-human studies.
Importantly, C2E2 development for radionuclide decorporation will proceed according to the FDA’s “Animal Rule” (Phase 2 and Phase 3 clinical studies are not required). The planned Phase 1 clinical study will determine C2E2 dosage for pivotal animal efficacy studies required for final approval and registration.
