The broadened designation includes all types of acute hereditary angioedema (HAE) attacks. HAE is a rare and life-threatening inflammatory condition for which there is no approved therapy in the US.
The trial is designed to determine the efficacy of DX-88 for patients suffering from moderate to severe acute HAE attacks. The trial is comprised of two phases, a double-blind, placebo-controlled phase which is now complete, and a repeat dosing phase. The second phase of the study will continue to treat patients and allows DX-88 to be administered for acute attacks.
“DX-88 has continued to demonstrate a good safety profile and has been well tolerated on single and multiple dosing,” said Henry Blair, chairman and CEO of Dyax.
Dyax has also successfully completed a phase I/II trial of DX-88 for the prevention of blood loss during on-pump CABG procedures.