Clinical trials represent a very important stage in the drug development process. These trials are conducted to evaluate the safety of an investigational drug and its efficacy in treating the targeted condition.

Dyax’s lead product candidate DX-88 (ecallantide), a recombinant small protein which was discovered from the Company’s patented phage display library, is currently in clinical trials in two separate indications.

DX-88 (ecallantide)
DX-88 is a highly specific and potent inhibitor (K_i =20-40 pM) of plasma kallikrein. Kallikrein is a key component in the regulation of inflammatory and blood clotting processes. Activated kallikrein is thought to play a role in a number of inflammatory and autoimmune conditions.

Our lead product candidate, DX-88 (ecallantide), is a recombinant form of a small protein that is currently in clinical trials for its therapeutic potential in two separate indications. The first such indication involves the use of DX-88 in the treatment of hereditary angioedema (HAE). In this indication, we have completed three Phase 2 trials and two Phase 3 trials. The second Phase 3 trial, EDEMA4, was conducted under a Special Protocol Assessment (SPA). DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S. for the treatment of acute attacks of HAE.

In the second indication for DX-88, we completed a Phase 1/2 trial for the prevention of blood loss during on-pump coronary artery bypass graft, or CABG surgery. In April 2008, we licensed to Cubist Pharmaceuticals the intravenous formulation of DX-88 for surgical indications in North America and Europe. Cubist is responsible for the ongoing development of DX-88 in this indication.

Discovery Pipeline

The discovery group is building a strong pipeline of innovative drug candidates. This pipeline has over ten active discovery programs focused in oncology and inflammation. 

DX-2400
The most advanced discovery candidate is the fully human monoclonal antibody, DX-2400, a novel protease inhibitor that specifically inhibits, matrix metalloproteinase 14 (MMP-14), on tumor cells and tumor blood vessels. DX-2400 offers a potential treatment for a broad range of solid tumors. It has been shown to significantly inhibit tumor progression and metastasis in multiple preclinical models in a dose-responsive manner when used as a monotherapy. DX-2400 offers potential for treating a broad range of solid tumors, including breast, prostrate, pancreatic and melanoma tumors.

DX-2240
In February 2008, Dyax signed two agreements with sanofi-aventis which granted exclusive worldwide rights to sanofi-aventis to develop and commercialize DX-2240, a preclinical candidate from our discovery pipeline, and non-exclusive license to our phage display technology. In addition to financial terms, Dyax retained co-development and profit sharing rights for certain sanofi-aventis discovered candidates. The fully human monoclonal antibody, DX-2240, has a novel mechanism of action that targets the Tie-1 receptor. The antibody has demonstrated activity against a broad range of solid tumor types and data have indicated increased activity when combined with other antiangiogenic therapies, such as Avastin^® and Nexavar^®.