Dyax Corp. Announces Expansion of Phase 1b Clinical Trial for DX-2930
November 03 2014 - 6:30AM
Business Wire
Rapid Trial Progress Enables Additional
Cohorts to be Studied
Dyax Corp. (NASDAQ: DYAX) today announced the expansion of its
ongoing Phase 1b clinical trial evaluating DX-2930 to include
additional patients and dosing cohorts. Dyax is developing DX-2930,
an investigational fully human monoclonal antibody inhibitor of
plasma kallikrein, as a subcutaneous injection for prevention of
hereditary angioedema (HAE) attacks.
The ongoing Phase 1b clinical trial is a multi-center,
randomized, double-blind, placebo-controlled, multiple ascending
dose study designed to assess the safety, tolerability and
pharmacokinetics of DX-2930 in HAE patients. As of October 31,
2014, 21 subjects were enrolled and completed dosing in three
ascending dose cohorts (30 mg, 100 mg and 300 mg) of DX-2930 or
placebo. Subjects in each cohort were randomized to active drug or
placebo in a 2:1 ratio. Each study subject received two doses of
study drug or placebo separated by 14 days and will undergo 15
weeks of follow-up after the second dose.
In light of faster than anticipated enrollment rates, Dyax has
decided to take the opportunity to further characterize DX-2930 by
adding two additional cohorts. Subjects will continue to be
randomized to active drug or placebo in a 2:1 ratio and the dosing
regimen will remain unchanged. Active drug-treated subjects in the
fourth cohort will receive 400 mg of DX-2930. The dose level of the
fifth cohort will be decided based upon a review of interim
data.
Addition of the new dosing cohorts is in accordance with the
provisions included in the original protocol which allows
enrollment into additional dose groups and/or additional patients
at any dose group. Total enrollment can be increased to as many as
36 patients and data from additional patients will be used to
expand the DX-2930 safety database and provide potentially
informative pharmacodynamic data.
“Strong investigator support for the Phase 1b trial has allowed
the study to progress rapidly and, at this time, the first three
dosing cohorts are fully enrolled,” said Burt Adelman M.D.,
Executive Vice President of Research and Development and Chief
Medical Officer at Dyax. “These additional cohorts will provide
safety, pharmacokinetic and pharmacodynamic data which will further
guide future clinical development of DX-2930. Importantly, we
remain on track to report data from this study in early 2015,
followed by a Phase 2 study which is also currently planned to
begin in 2015.”
"Developing a prophylactic treatment for HAE patients is a key
value driver for Dyax and we are encouraged by the rapid progress
we are seeing with this trial," said Gustav Christensen, President
and Chief Executive Officer of Dyax. "We believe DX-2930’s unique
product profile positions it well as a potential preventative
treatment for HAE attacks.”
About DX-2930DX-2930 is a novel, fully human monoclonal
antibody inhibitor of plasma kallikrein (pKal) and is being
developed by Dyax as a subcutaneous injection for the prevention of
HAE attacks. 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.
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® (ecallantide) for the treatment of
acute attacks of hereditary angioedema (HAE) in patients 12 years
of age and older. Dyax is also developing DX-2930, a fully human
monoclonal antibody, for the potential prophylactic treatment of
HAE.
Both KALBITOR and DX-2930 were identified using Dyax's
proprietary 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 LFRP. The
Company is eligible to receive future milestones and/or royalties
dependent upon the development and commercialization of these
candidates. In 2014, Dyax’s licensee Eli Lilly and Company began
marketing their FDA approved product, CYRAMZA® (ramucirumab), as a
single-agent treatment for patients with advanced gastric cancer
after prior chemotherapy, making this the first royalty-bearing
therapeutic 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 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.CYRAMZA® is a registered trademark of Eli Lilly and
Company.
Dyax Corp.Jennifer Robinson, 617-250-5741Director, Investor
Relations and Corporate Communicationsjrobinson@dyax.com
Dyax (NASDAQ:DYAX)
Historical Stock Chart
From Apr 2024 to May 2024
Dyax (NASDAQ:DYAX)
Historical Stock Chart
From May 2023 to May 2024