Positive Topline Results from Phase II Trial (EDEMA2) with DX-88 for the Treatment of Hereditary Angioedema Presented at AAAAI Meeting
Monday March 6, 7:30 am ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 6, 2006--Dyax Corp. (Nasdaq:DYAX - News) today announced the presentation of positive topline data from the Company's completed open-label Phase II clinical trial, referred to as EDEMA2, with DX-88 for the treatment of hereditary angioedema (HAE). In this study DX-88 was well tolerated and successful in treating all types of attacks, including peripheral, abdominal and life-threatening laryngeal attacks, whether administered through the intravenous (IV) or subcutaneous (SQ) route of administration. DX-88 is being developed in a joint venture with Genzyme Corporation for the treatment of HAE, a debilitating and life-threatening inflammatory condition characterized by unpredictable attacks of severe pain and swelling.
Dr. William Lumry, M.D., medical director and principal investigator of AARA Research Center of Dallas, TX, presented topline data from Dyax's open-label, EDEMA2 (Evaluation of DX-88's Effects on Mitigating Angioedema) trial in an oral presentation titled, "A Multicenter, Open-Label, Study of DX-88 for Multiple Attacks of Hereditary Angioedema; EDEMA2 Interim Results" at the American Academy of Asthma, Allergy & Immunology Conference (AAAAI) in Miami Beach, FL on Sunday, March 5, 2006.
The topline results indicate that, in this study, DX-88 provided substantial therapeutic benefit in HAE patients who experienced acute attacks, including life-threatening laryngeal attacks. Dr. Lumry presented results on a subset of the 240 attacks that were treated in the trial. He presented data on 215 attacks observed in 72 patients who had variable or fixed doses of DX-88, either 5 mg/m2, 10 mg/m2 or 20 mg/m2 intravenously or 30 mg subcutaneously. Of the 215 attacks analyzed in the presentation, 176 attacks were treated in 62 patients through IV infusion and 39 attacks were treated in 22 patients through SQ administration, with 42 patients receiving multiple doses. Of the patients treated for multiple attacks, one was dosed 10 times, another 12 and a third 18 times.
In this study, all types of attacks were treated by either IV or SQ administration of DX-88: laryngeal (n=31, 14.4%), abdominal (n=101, 47.0%), and peripheral (n=83, 38.6%). Clinical response, defined as beginning of improvement of HAE symptoms within four hours of dosing with DX-88, was observed at all dose levels. For the IV dosing (5 mg/m2, 10 mg/m2, 20 mg/m2), the response rates ranged from 86% to 100%, while the SQ outcome (30 mg fixed dose) showed a 100% response rate. The overall median time to onset of improvement for the 215 attacks was 28 minutes. The time to onset of response was slightly better (20 minutes) with SQ compared to IV administration. In a preliminary analysis, data to date indicate that time to significant improvement as well as maintenance of response at 24 hours appear to be dose and route dependent with the 30 mg SQ dose being superior to the IV administration at any dose.
With regard to the overall safety profile of DX-88 in EDEMA2, the drug has been well tolerated. There have been no local injection site reactions. In the overall DX-88 experience to date, eight patients (4%) have experienced an acute dosing reaction: six patients on first administration (two patients in EDEMA2) of the IV infusion (probably related to infusion rate) and two patients (both in EDEMA2) after multiple administration (one IV and one SQ). These symptoms included rhinitis, flushing and nausea, but with no evidence of anaphylaxis, such as tryptase elevation. All patients responded rapidly to the treatment and had complete resolution of the HAE symptoms, showing no decrease in efficacy of the drug upon repeat dosing.
DX-88 antibodies have been detected in three patients treated in this study. One patient had DX-88 antibodies with no apparent impact. Two patients with antibodies did manifest single, separate acute dosing reactions. Both patients have since been rechallenged, with one patient being retreated three times subsequent to rechallenge. There has been no recurrence of these side effects in either patient or decrease in efficacy in the patient retreated for HAE symptoms.
Commenting on the program, Dr. Lumry stated, "I'm very impressed with the DX-88 results to date. Since there is no current treatment in the U.S. for acute HAE attacks, I believe that, if approved, DX-88 has great potential in the U.S. market." He added, "HAE patients live in constant fear of having an attack, and Dyax and Genzyme are tackling this issue head on in their trials. I continue to be encouraged by the high response rates to date and believe that DX-88 represents a real possible breakthrough in the treatment of hereditary angioedema."
Dr. Thomas R. Beck, President and Chief Operating Officer of Dyax Corp., stated, "We are extremely pleased with the topline results from our EDEMA2 trial. In this open-label trial, we were able to move to a fixed dose of 30 mg, the same dose currently being administered subcutaneously in our ongoing pivotal Phase III trial. By January 2006, we had administered 327 doses of DX-88 to 113 angioedema patients. With the breadth and depth of data from our program to date, we think that it is clear that we are on the right track to be first to market with a treatment for the U.S. HAE population." |
