CSL’s Phase 3 Study Shows First-In-Class Garadacimab Provides Patients with Sign… – Press Release

• Majority of patients were attack free during the entire six-month treatment period (61.5%)
• Study results presented for first time at 2023 AAAAI Annual Meeting; global regulatory submissions anticipated later in the calendar year
• Garadacimab underscores CSL’s promise to develop innovative medicines for people living with rare diseases like HAE, a community CSL has been serving for 40 years

KING OF PRUSSIA, Pa., Feb. 26, 2023 /PRNewswire/ — Global biotechnology leader CSL (CSLCSLLY today presented results from the pivotal placebo-controlled Phase 3 VANGUARD clinical trial of garadacimab (CSL312). Garadacimab is CSL’s investigational first-in-class monoclonal antibody being developed as a long-term prophylactic treatment for patients with hereditary angioedema (HAE). Results from the trial, the first to investigate targeting activated Factor XII (FXIIa) to prevent HAE attacks, showed that once-monthly subcutaneous injections of garadacimab significantly reduced the attack rate compared to placebo. The data were presented during the 2023 American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting, February 24-27, in San Antonio, Texas.

“Targeting FXIIa and the HAE cascade from the start, as opposed to intervening downstream, is an innovative treatment approach that could help stop the process in its tracks,” said Dr. Timothy Craig, Tenured Professor of Medicine, Pediatrics and Biomedical Sciences at Penn State University and Principal Investigator of the study. “The Phase 3 data we are presenting support the potential use of garadacimab as a prophylactic therapy for HAE.”

Key Data from the Phase 3 VANGUARD Trial
During the double-blind, randomized, placebo-controlled, multicenter, parallel-group study, patients taking once monthly garadacimab (n=39) experienced a statistically lower monthly attack rate versus placebo (n=24) (p< 0.001), resulting in a mean attack rate reduction of 86.5% versus placebo, and a median attack rate reduction of 100% versus…

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