Management to Host Conference Call with
Detailed Data Presentation Today at 5:00 p.m. ET
Dyax Corp. (NASDAQ:DYAX) today announced positive safety,
pharmacokinetic, biomarker, and efficacy results from the Phase 1b
clinical study of their investigational product, DX-2930.
Discovered by Dyax, DX-2930 is a fully human monoclonal antibody
inhibitor of plasma kallikrein being developed for the prevention
of hereditary angioedema (HAE) attacks.
The ongoing Phase 1b study 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. An analysis of HAE attack rate was also
conducted following a pre-specified statistical analysis plan. A
total of 37 subjects were randomized to active drug or placebo in a
2:1 ratio across 4 dosing groups of 30, 100, 300, or 400 mg. Each
subject received two doses of DX-2930 or placebo, separated by 14
days, and was followed for 15 weeks after the second dose.
DX-2930 was well tolerated at all dose levels. There were no
deaths or subject discontinuations due to an adverse event. There
were no serious adverse events in subjects treated with DX-2930 and
no evidence of dose-limiting toxicity. There was no safety signal
in treatment-emergent adverse events, clinical laboratory results,
vital signs, or electrocardiograms. Subcutaneous injection was well
tolerated.
Pharmacokinetic results demonstrated that DX-2930 has linear,
dose-dependent exposure and a mean elimination half-life of
approximately 14 days across all dose groups studied.
Pharmacodynamic results from two different exploratory biomarker
assays confirmed ex vivo plasma kallikrein inhibition in a dose-
and time-dependent manner.
Primary proof-of-concept efficacy analyses were based on
subjects in the 300 mg, 400 mg, and placebo dose groups who
reported having at least 2 attacks in the 3 months prior to study
entry. During the pre-specified, primary efficacy interval of 6
weeks (from days 8 to 50; corresponding to peak drug level), the
HAE attack rate (adjusted for baseline attacks) was 0 in the 300 mg
group and 0.045 attacks per week in the 400 mg group, compared to
0.37 attacks per week in the placebo group. This resulted in a 100%
reduction for the 300 mg dose group as compared to placebo
(P<0.0001), and an 88% reduction for the 400 mg dose group as
compared to placebo (P=0.005). During this primary efficacy
interval, 100% of subjects in the 300 mg group (P=0.026) and 82% of
subjects in the 400 mg group (P=0.030) were attack-free compared
with 27% of subjects in the placebo group. The study will be
complete when all subjects in the 400 mg dose group finish the
final safety assessments on study day 120.
Today Dyax also announced receipt of Fast Track designation from
the U.S. Food and Drug Administration (FDA) for the investigation
of DX-2930 for HAE.
“These data provide important clinical proof-of-concept, dose
response and safety information in the target patient population,”
said Burt Adelman, M.D., Executive Vice President of Research and
Development and Chief Medical Officer at Dyax. “The study met all
of its primary objectives, and notably, DX-2930 also demonstrated
statistically significant reductions in attack rate compared to
placebo, an important characteristic for a prophylactic treatment.
We look forward to communicating these results to the FDA to ensure
that our product development plan is supportive of drug approval.
We plan to take full advantage of the opportunities that Fast Track
designation allows in order to maximize the possibility of a more
rapid path to approval.”
“The positive results from this trial are a significant
milestone for Dyax and will be integral in guiding the future
clinical development of DX-2930,” said Gustav Christensen,
President and Chief Executive Officer of Dyax. “If approved, we
believe that DX-2930, with its unique profile, is well positioned
as a potential preventive treatment option for patients suffering
from HAE.”
Conference Call & Webcast
Date:
Tuesday, March 31, 2015
Time:
5:00 p.m. ET
Telephone Access:
Domestic callers, dial 877-674-2415, International callers, dial
708-290-1364, Reference the Dyax conference call;
Online Access:
Go to the Investor Relations section of
the Dyax website (http://investor.dyax.com/index.cfm)and follow
instructions for accessing the live webcast. Please connect to the
websiteat least 15 minutes prior to the start of the conference
call to ensure adequate timefor any software download that may be
necessary.
About DX-2930DX-2930 is a novel, fully human monoclonal
antibody inhibitor of plasma kallikrein (pKal) which is currently
being developed 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 Hereditary Angioedema (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 DyaxDyax is a fully integrated biopharmaceutical
company focused on the development and commercialization of novel
biotherapeutics for unmet medical needs. The Company currently
markets KALBITOR® (ecallantide) for the treatment of acute attacks
of 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 under its Licensing and Funded Research Portfolio
(LFRP). The current portfolio includes one FDA approved product,
Eli Lilly and Company’s CYRAMZA® (ramucirumab), for which Dyax
receives royalties, and multiple product candidates in various
stages of clinical development for which the Company is eligible to
receive future milestones and/or royalties.
For additional information about Dyax, please visit
www.dyax.com.
For additional information about KALBITOR, including full
prescribing information, please visit www.KALBITOR.com.
DisclaimerThe press release contains forward-looking
statements, including statements regarding the prospects for
therapeutic benefits and treatment advantages of an investigational
product, DX-2930, being developed for HAE. 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 competes. The statements
contained in this press release are not guarantees of future
performance and involve certain risks, uncertainties and
assumptions that are difficult to predict. Therefore, actual
outcomes and results may differ materially from what is expressed
in such forward-looking statements. There are many factors that
could cause actual results to differ materially from those in these
forward-looking statements. These factors include the following:
the results from our Phase 1b study may not be predictive of the
results or success of future clinical trials that will be required
to permit application for regulatory approval of DX-2930; even if
DX-2930 progresses through clinical trials and gains regulatory
approval, it may not gain market acceptance; others may develop
technologies or products superior to DX-2930 or that reach the
market before DX-2930; Dyax is dependent on the expertise, effort,
priorities and contractual obligations of third parties in the
manufacture, quality control, storage and clinical development of
DX-2930; the costs of prosecuting, maintaining, defending and
enforcing our patents and other intellectual property rights; the
overall condition of the financial markets; and a variety of other
risks common to our industry; 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
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