CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ:DYAX - News) announced today positive topline results from its second Phase 3, placebo-controlled trial, EDEMA4, for its lead product candidate DX-88 (ecallantide) for hereditary angioedema (HAE). The EDEMA4 trial, conducted under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA), achieved statistically significant improvements in the intent-to-treat population in primary and secondary endpoints. DX-88 was also found to be well tolerated with no drug-related serious adverse events reported in the EDEMA4 trial. Based on the safety and efficacy results from its EDEMA4 and EDEMA3 Phase 3 trials, Dyax intends to submit the last module of its Biologics License Application (BLA) to the FDA early in the fourth quarter of 2008.
The primary endpoint of EDEMA4, patient reported assessment of individual symptom burden at four hours measured using the Mean Symptom Complex Severity (MSCS) score, had a p-value of 0.010. Symptom improvement at four hours measured by a Treatment Outcome Score (TOS), a secondary endpoint, had a p-value of 0.003. Other secondary endpoints reported on the proportion of responders and the sustainability and durability of response. The proportion of patients with successful response at four hours was 93.8% for the DX-88-treated group versus 58.3% for the placebo group (p=0.001). The proportion of patients maintaining significant improvement in overall response (defined for this trial as patient response to “Overall how are you feeling?” as “a lot better or resolved” prior to the 4-hour post dosing assessment and through the 24-hour post dosing assessment) was 43.8% for the DX-88-treated group versus 20.8% for the placebo group (p= 0.022).
The EDEMA4 topline results are consistent with the positive outcomes of the EDEMA3 trial, Dyax’s first Phase 3, placebo-controlled trial for this indication. EDEMA3 also demonstrated statistically significant and clinically meaningful results. The positive data further support the validity of the patient reported outcome (PRO) methodology used in both Phase 3 trials. Safety results from this Phase 3 trial continue to show that DX-88 is well tolerated.
“The positive results from our EDEMA4 and EDEMA3 trials support the potential of DX-88 as an important acute therapy for HAE patients. Moreover, DX-88’s profile as a recombinant, subcutaneous therapy, may offer treatment advantages to patients suffering from this debilitating and life-threatening disease,” commented William E. Pullman, M.D., Ph.D., FRACP, Executive Vice President and Chief Development Officer of Dyax.
“We are extremely pleased that the EDEMA4 results validate the promise of DX-88 as a potential treatment solution for the HAE community,” commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax. “The DX-88 BLA will include the most extensive placebo-controlled assessment of any therapy for the treatment of HAE and was based on a Dyax-developed comprehensive endpoint evaluation. We look forward to submitting our BLA and, ultimately, commercializing this innovative therapy.”
DX-88, a potent and selective, recombinant, plasma kallikrein inhibitor, is being evaluated for the treatment of acute attacks of HAE, a rare genetic disease characterized by episodes of acute swelling, pain and inflammation.
EDEMA4 Trial
EDEMA4, a 96-patient, double-blind, placebo-controlled, multi-center, Phase 3 trial, was conducted at 42 sites in the United States and Canada. The primary objective of EDEMA4 was to determine the efficacy and safety of the fixed 30 mg subcutaneous dose of DX-88 in the treatment of moderate to severe acute HAE attacks.
Conference Call Details
Dyax Corp. will host a conference call on Monday, August 18, 2008, which will include a discussion of the topline EDEMA4 results in more detail.
Time: 10:00 a.m. ET
Online Access:
Go to the Investor Relations section of the Dyax website (www.dyax.com) and follow instructions for accessing the live webcast. Participants may register in advance.
Telephone Access:
Domestic callers, dial 1-800-798-2796
International callers, dial 1-617-614-6204
Passcode 32326837
A replay of the conference call will be available through September 15, 2008 and may be accessed by dialing 1-888-286-8010. International callers should dial 1-617-801-6888. The replay passcode for all callers is 31367729. The webcast will be archived on the Dyax website for an indefinite period of time.
About Dyax
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax’s lead product candidate is DX-88 (ecallantide), a recombinant small protein that is currently in clinical trials for its therapeutic potential in two separate indications. Dyax has completed three Phase 2 trials and two Phase 3 trials of DX-88 for the treatment of hereditary angioedema (HAE). The second Phase 3 trial, known as 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. Additionally, Dyax has completed a Phase 1/2 trial of DX-88 for the prevention of blood loss during on-pump coronary artery bypass graft (CABG) procedures. In April 2008, Dyax licensed to Cubist Pharmaceuticals the intravenous formulation of DX-88 for surgical indications in North America and Europe. Cubist is responsible for its ongoing development in these indications. Dyax identified DX-88 and other compounds in its pipeline using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents.
Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.
Dyax Disclaimer
This press release contains forward-looking statements, including statements regarding the prospects for potential administration, dosing, safety and therapeutic benefits and treatment advantages of DX-88 for HAE and the timing and prospects for filing, review and FDA approval of the BLA for DX-88. Statements that are not historical facts are based on Dyax’s current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors which may affect the prospects for potential administration, dosing and therapeutic benefits and treatment advantages of DX-88 for HAE, and the timing and prospects for filing, review and FDA approval of the BLA for DX-88, include the risks that: DX-88 may not show sufficient therapeutic effect or an acceptable safety profile in clinical trials or could take a significantly longer time to gain regulatory approval than Dyax expects or may never gain approval; others may develop technologies or products superior to DX-88 or that are on the market before DX-88; DX-88 may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacture, marketing, sales and distribution of DX-88; and other risk factors described or referred to Item 1A, “Risk Factors” in Dyax’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.
Dyax and the Dyax logo are registered trademarks of Dyax Corp. EDEMA3 and EDEMA4 are registered service marks.
Contact:
Dyax Corp. Ivana Magovcevic-Liebisch, 617-250-5759 Executive Vice President of Administration and General Counsel imagovcevic@dyax.com or Nicole Jones, 617-250-5744 Director, Investor Relations njones@dyax.com
Source: Dyax Corp.
