Takeda Pharma Says Phase 3 SHP643-301 Study Of Takhzyro Meets Objectives

(RTTNews) - Japan's Takeda Pharmaceutical Co. Ltd. (TAK) announced Tuesday that the Phase 3 SHP643-301 study (NCT04070326) evaluating the safety profile and pharmacokinetics (PK) of Takhzyro (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives.

The safety profile was consistent with that seen in the clinical program for patients 12 years of age and older, with no serious adverse events and no dropouts due to adverse events.

The study also successfully reached the secondary objective evaluating the clinical activity/outcome of Takhzyro in preventing hereditary angioedema (HAE) attacks as well as characterizing the pharmacodynamics of TAKHZYRO in pediatric subjects 2 to <12 years of age.

SHP643-301, also known as the SPRING study, is a multicenter, open-label Phase 3 study to evaluate the safety, PK and PD of TAKHZYRO for prevention against acute attacks of HAE in pediatric patients 2 to <12 years of age. Takhzyro is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for routine prevention of recurrent attacks of HAE in patients aged 12 years and older.