Dyax Corp. (NASDAQ: DYAX) today announced dosing of the first subject in its Phase 1b clinical study of DX-2930 in hereditary angioedema (HAE) patients. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of multiple subcutaneous administrations of DX-2930, an investigational fully human monoclonal antibody inhibitor of plasma kallikrein. Dyax, a biopharmaceutical company focused on HAE and other plasma-kallikrein-mediated disorders, is developing DX-2930 as a subcutaneous injection for prevention of HAE attacks.
“The primary purpose of this Phase 1b study is to gain important safety and pharmacokinetic data in the target patient population,” said Burt Adelman M.D., Executive Vice President of Research and Development and Chief Medical Officer at Dyax. “The pharmacodynamic effects of DX-2930 on plasma kallikrein will also be evaluated. Data from this study will guide dosing decisions for future clinical development. We’ll also be utilizing our biomarker assay to assess the possible impact of DX-2930 on exploratory pharmacodynamic parameters such as basal plasma kallikrein activity. We anticipate reporting data from this trial early in 2015.”
This Phase 1b trial is a multi-center, randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of DX-2930 in HAE patients. Approximately 18 subjects will be enrolled into three ascending dose cohorts (30 mg, 100 mg and 300 mg) of DX-2930 or placebo. There will be 4 active drug-treated subjects and 2 placebo-treated subjects per cohort. Each subject will receive two treatments with study drug, separated by two weeks, and undergo approximately 15 weeks of follow-up after the second dose.
“Expanding our HAE product offerings is a priority for Dyax and we are executing on our clinical goals with DX-2930,” said Gustav Christensen, President and CEO of Dyax. “Data generated from the Phase 1b study will provide the basis for us to continue to advance DX-2930. We believe that, if approved, DX-2930 has the potential to be a game-changing therapy for HAE patients.”