Dyax Corp. (NASDAQ: DYAX) today announced the online publication of scientific data for DX-2930, an investigational fully human monoclonal antibody inhibitor of plasma kallikrein (pKal), in two peer-reviewed journals. 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. The first paper titled “A Phase 1 Study Investigating DX-2930 in Healthy Subjects” by Chyung et al. was published online in the Annals of Allergy, Asthma and Immunology. The paper describes the positive results from the first-in-human clinical study of DX-2930 which met all of its objectives of assessing safety, tolerability and pharmacokinetics of this investigational drug candidate. These data indicate that DX-2930 has a long half-life in humans and thus the potential for prophylactic inhibition of pKal activity for the therapeutic treatment of HAE. DX-2930 is now being evaluated in a Phase 1b study in patients with HAE. The complete publication can be accessed online here. The second paper titled “Inhibition of Plasma Kallikrein by a Highly Specific, Active Site Blocking Antibody” by Kenniston et al. was published online in The Journal of Biological Chemistry. The paper describes the discovery and preclinical evaluation of DX-2930 as a long-acting inhibitor of pKal proteolytic activity. This paper is expected to appear in the September 2014 (Volume , Issue ) print issue of the journal. The complete publication can be accessed online here. Dr. Burt Adelman, Executive Vice President of Research and Development and Chief Medical Officer, commented: “We are delighted to have two important, peer-reviewed papers published in these prestigious scientific journals. Publication of these papers confirms the significance of DX-2930 in the scientific community. These data, combined with data that will be obtained from the ongoing Phase 1b study, will inform and guide the future clinical development of DX-2930.”
About DX-2930DX-2930 is a novel, fully human monoclonal antibody inhibitor of plasma kallikrein (pKal). Uncontrolled pKal activity leads to excessive generation of bradykinin, a vasodilator thought to be responsible for the localized swelling, inflammation and pain characteristically associated with HAE. Dyax is currently developing DX-2930 as a subcutaneous injection for the prevention of HAE attacks and expects to report data from a Phase 1b trial early in 2015. About HAE 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. About Dyax Dyax is a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of novel biotherapeutics for unmet medical needs. The Company currently markets KALBITOR ® for the treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. Dyax is also developing DX-2930 for the prophylactic treatment of HAE. Both KALBITOR and DX-2930 were identified using Dyax's patented phage display technology. Dyax has broadly licensed this technology and has a portfolio of product candidates being developed by our licensees, which it refers to as the Licensing and Funded Research Portfolio (LFRP). The Company is eligible to receive future milestones and/or royalties dependent upon the development and commercialization of these candidates. In April 2014, Dyax’s licensee Lilly received FDA approval for CYRAMZA™ (ramucirumab) as a single-agent treatment for patients with advanced gastric cancer after prior chemotherapy, making this the first approved product from Dyax’s LFRP.
For additional information about Dyax, please visit www.dyax.com.For additional information about KALBITOR, including full prescribing information, please visit www.KALBITOR.com. Disclaimer This press release contains forward-looking statements, including statements regarding the prospects for the clinical development of 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 risks, uncertainties and assumptions involved in any future projections. There are many factors that could cause actual results to differ from these forward-looking statements, including: risks and uncertainties relating to the clinical development of DX-2930; Dyax's dependence on the expertise, effort, priorities and contractual obligations of third parties in the manufacture, quality control, storage and clinical development of DX-2930; changing requirements and costs associated with Dyax's planned research and development activities; competition from new and existing treatments for HAE; the uncertainty of patent and intellectual property protection; and other risk factors described or referred to in 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.