Dyax Corp. (NASDAQ: DYAX) today announced dosing of the first subject in its Phase 1b clinical study of DX-2930 in hereditary angioedema (HAE) patients. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of multiple subcutaneous administrations of DX-2930, an investigational fully human monoclonal antibody inhibitor of plasma kallikrein. Dyax, a biopharmaceutical company focused on HAE and other plasma-kallikrein-mediated disorders, is developing DX-2930 as a subcutaneous injection for prevention of HAE attacks. “The primary purpose of this Phase 1b study is to gain important safety and pharmacokinetic data in the target patient population,” said Burt Adelman M.D., Executive Vice President of Research and Development and Chief Medical Officer at Dyax. “The pharmacodynamic effects of DX-2930 on plasma kallikrein will also be evaluated. Data from this study will guide dosing decisions for future clinical development. We’ll also be utilizing our biomarker assay to assess the possible impact of DX-2930 on exploratory pharmacodynamic parameters such as basal plasma kallikrein activity. We anticipate reporting data from this trial early in 2015.” This Phase 1b trial is a multi-center, randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of DX-2930 in HAE patients. Approximately 18 subjects will be enrolled into three ascending dose cohorts (30 mg, 100 mg and 300 mg) of DX-2930 or placebo. There will be 4 active drug-treated subjects and 2 placebo-treated subjects per cohort. Each subject will receive two treatments with study drug, separated by two weeks, and undergo approximately 15 weeks of follow-up after the second dose. “Expanding our HAE product offerings is a priority for Dyax and we are executing on our clinical goals with DX-2930,” said Gustav Christensen, President and CEO of Dyax. “Data generated from the Phase 1b study will provide the basis for us to continue to advance DX-2930. We believe that, if approved, DX-2930 has the potential to be a game-changing therapy for HAE patients.”
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 its Phase 1b trial in the early in 2015.About HAEHAE 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 DyaxDyax 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. Additionally, the Company has developed a biomarker assay that detects activated plasma kallikrein in blood and is being used for internal research and development efforts, including the exploration and identification of other plasma kallikrein-mediated indications beyond 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 its 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. DisclaimerThis 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 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.