Dyax Corp. Announces Dosing of First Subject in Phase 1 Trial of DX-2930 for Prevention of HAE Attacks
BURLINGTON, Mass.--(BUSINESS WIRE)-- Dyax Corp. (NAS: DYAX) today announced dosing of the first subject in a Phase 1 clinical study evaluating the safety and tolerability of single subcutaneous administration of DX-2930, its fully human monoclonal antibody inhibitor of plasma kallikrein. Dyax, a biopharmaceutical company focused on hereditary angioedema (HAE) and other plasma kallikrein-mediated disorders, is developing DX-2930 as a subcutaneous injection for prevention of HAE attacks. DX-2930 was discovered using Dyax's proprietary phage display technology platform.
"There is significant need for a highly effective, safe and well tolerated prophylactic agent to treat HAE," said Burt Adelman M.D., Executive Vice President and Chief Medical Officer at Dyax. "DX-2930 is a highly potent, long-acting, fully human monoclonal antibody that binds specifically to active plasma kallikrein. We look forward to completing this study and moving forward rapidly with this important clinical program."
This Phase 1, single-center, randomized, double-blind, placebo-controlled study is designed to assess the safety and tolerability and to characterize the pharmacokinetics (PK) of single, subcutaneous administrations of DX-2930 in healthy subjects. Approximately 32 subjects will be enrolled into four ascending dose cohorts (n=8 per cohort) of DX-2930 or placebo. The study will be conducted at the clinical trials unit of Vince & Associates Clinical Research, a recognized "Center of Research Excellence", located in Overland Park, Kansas.
"The successful dosing of the first subject in this Phase 1 clinical study is an important milestone for the DX-2930 development program," said Gustav Christensen, President and CEO of Dyax. "We believe our knowledge of the plasma kallikrein pathway provides us with unique insight and a significant advantage in developing and commercializing this product candidate."
Discovered using Dyax's proprietary phage display technology platform, DX-2930 is a novel, fully human monoclonal antibody inhibitor of plasma kallikrein. Uncontrolled plasma kallikrein activity leads to excessive generation of bradykinin, a vasodilator thought to be responsible for the localized swelling, inflammation and pain characteristically associated with HAE. Preclinical studies suggest that DX-2930 will have a long half-life in humans, offering the potential for a long-acting and sustained therapeutic effect with less frequent dosing. Dyax is currently developing DX-2930 as a subcutaneous injection for the prevention of HAE attacks.
HAE is a rare acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, gastrointestinal tract, genitalia, and larynx. HAE is caused by low or dysfunctional levels of C1 esterase inhibitor (C1-INH), a naturally occurring molecule that inhibits plasma kallikrein, a key mediator of inflammation, and other serine proteases in the blood. HAE is estimated to affect up to 1 in 50,000 individuals. Learn more at www.HAEHope.com.
Dyax is a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of novel biotherapeutics for unmet medical needs. The Company's key value drivers are the KALBITOR® (ecallantide) business, DX-2930 and the Licensing and Funded Research Program (LFRP).
Dyax developed KALBITOR on its own and, since February 2010, has been selling it in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older. Outside the United States, the Company has established partnerships to obtain regulatory approval and commercialize KALBITOR in certain markets and is evaluating opportunities in others.
The Company is developing products to expand its angioedema portfolio, including a therapeutic candidate, DX-2930, for the prophylactic treatment of HAE and a diagnostic test to identify plasma kallikrein-mediated disorders.
KALBITOR and DX-2930 were identified using Dyax's patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly through the LFRP. This program has provided the Company a portfolio of product candidates being developed by its licensees, which currently includes 13 revenue generating product candidates in various stages of clinical development, including three in Phase 3 trials.
For additional information about Dyax, please visit www.dyax.com.
For additional information about KALBITOR, including full prescribing information, please visit www.KALBITOR.com.
This press release contains forward-looking statements, including statements regarding the prospects for the Phase 1 clinical trial for DX-2930. 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 and its licensees compete. 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 because of uncertainties involved in any future projections, as well as uncertainties associated with various activities and aspects of Dyax's business, including risks and uncertainties associated with the following: competition from new and existing treatments for HAE; changing requirements and costs associated with Dyax's planned research and development activities; the uncertainty of patent and intellectual property protection; Dyax's dependence on key management and key suppliers; 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, the Dyax logo and KALBITOR are registered trademarks of Dyax Corp.
Jennifer Robinson, 617-250-5741
Associate Director, Investor Relations and Corporate Communications
KEYWORDS: United States North America Massachusetts
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