Dyax Corp. Announces Dosing of First Subject in Phase 1b Trial of DX-2930 in Patients with Hereditary Angioedema
May 28 2014 - 7:15AM
Business Wire
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.
Dyax Corp.Jennifer Robinson, 617-250-5741Director, Investor
Relations and Corporate Communicationsjrobinson@dyax.com
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