Dyax and Genzyme Initiate Pivotal Phase III Trial of Subcutaneously Administered DX-88 for the Treatment of Hereditary Angioedema
Thursday December 8, 10:17 am ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 8, 2005--Dyax Corp. (Nasdaq:DYAX - News) and Genzyme Corporation (Nasdaq:GENZ - News) announced today that patient treatment has begun in their pivotal Phase III clinical trial of Dyax's recombinant plasma kallikrein inhibitor known as DX-88. In this trial, referred to as EDEMA3, DX-88 is being studied for the treatment of patients with hereditary angioedema (HAE), a rare, genetic disease that causes acute attacks of localized swelling and inflammation.
The EDEMA3 trial is being conducted to confirm efficacy of a subcutaneous administration of DX-88 in patients suffering from moderate to severe acute HAE attacks. DX-88 inhibits human plasma kallikrein, which is an enzyme that is thought to be responsible for the activation of molecules that cause swelling and pain associated with HAE.
The evaluation of DX-88 in the HAE indication is being conducted by Dyax under its collaboration with Genzyme Corporation. In this joint venture, Dyax will now receive a $3 million milestone payment from Genzyme for the start of the pivotal trial and will receive an additional $10 million milestone payment upon FDA approval of the compound.
Phase III Design
The Phase III study will be conducted at 47 U.S. and Canadian clinical sites, along with additional clinical sites in Europe and Israel. Dyax and Genzyme expect to have rapid enrollment into the trial and target regulatory approval in the U.S. in 2007, followed by approval in the E.U.
The EDEMA3 study is comprised of two phases: a double-blind, placebo-controlled phase and a repeat dosing phase in which all patients will receive drug. In the first phase, HAE patients will receive either a single 30 mg subcutaneous (SQ) dose of DX-88 or placebo. After patients receive one treatment in the placebo-controlled portion of the study, they then will be eligible for the second phase where they all will receive repeat dosing with SQ DX-88 for any subsequent acute attacks. This trial is planned for 62 patients and will include patients previously exposed to DX-88 as well as naive patients.
"We are very pleased about achieving this significant milestone in our HAE program as planned," stated Henry Blair, Chairman, President and Chief Executive Officer of Dyax. "With our large network of patients and physicians behind us, we believe we can complete this pivotal trial rapidly. Based on the amount of data collected to date and the continued steady progress of this program, it is evident that Dyax, together with Genzyme, is focused on and truly committed to bringing DX-88 to the marketplace as the first subcutaneous treatment for the HAE patient community."
"We are extremely excited about treating the first patient in the EDEMA3 trial," remarked the investigational team of Dr. Henry Li and his associate Kelly Bowie of the Institute for Asthma & Allergy in Wheaton, MD. "Currently, there is no treatment for HAE in the United States and with the start of this trial, Dyax and Genzyme are one step closer to a potential drug being approved and on the market for the HAE patient community. We are enthusiastic about our participation in the EDEMA3 trial and look forward to its rapid conclusion."
Cumulative Data
Dyax and Genzyme continue to build upon their clinical data through their extensive DX-88 development program. With regard to clinical data accumulated in the EDEMA trials to date, 303 doses of DX-88 have been administered to 109 angioedema patients. With regard to safety data, 428 doses of DX-88 have now been administered to 177 people. |
