Results Provide Important Clinical
Proof-of-Concept, Dose Response and Safety Information in the
Target Patient Population
Dyax Corp. (NASDAQ:DYAX) today announced that clinical data from
its DX-2930 Phase 1b study was selected as a late-breaking abstract
and presented on June 7, 2015 at the European Academy of Allergy
and Clinical Immunology (EAACI) Annual Congress in Barcelona,
Spain. Discovered by Dyax, DX-2930 is an investigational fully
human monoclonal antibody inhibitor of plasma kallikrein being
developed for the prevention of hereditary angioedema (HAE)
attacks.
The late-breaking, oral presentation, titled “Interim Analysis
Results of a Phase 1b, Multiple Ascending Dose Study to Evaluate
DX-2930, a Fully Human Monoclonal Antibody Inhibitor of Plasma
Kallikrein in Development for Long-term Prophylaxis of Hereditary
Angioedema,” was given by Aleena Banerji, M.D., Assistant Professor
of Medicine at Harvard Medical School and attending physician at
Massachusetts General Hospital, on Sunday, June 7 at 1:30pm CET.
The oral presentation highlighted results from Dyax’s Phase 1b
clinical study assessing the safety, tolerability and
pharmacokinetics of DX-2930 in HAE patients.
“The clinical research findings presented yesterday at the EAACI
Annual Congress continue to expand our understanding of the safety,
pharmacokinetics and pharmacodynamics of DX-2930 in patients with
HAE,” said Dr. Banerji. “Results from this study also provided
proof-of-concept efficacy data demonstrating statistically
significant reductions in attack rate compared to placebo. These
results support further clinical investigation of DX-2930 in HAE
patients to potentially prevent HAE attacks.”
“We are pleased to have our Phase 1b DX-2930 data selected for
oral presentation at the EAACI,” said Burt Adelman, M.D., Executive
Vice President of Research and Development and Chief Medical
Officer at Dyax. “These data are significant because they indicate
that DX-2930 may be a viable prophylactic treatment option for HAE.
The 120-day follow-up period for the final dosing cohort was
completed in May, and we look forward to reporting the full study
results in the near future.”
DX-2930 Phase 1b Study Results
The Phase 1b study results demonstrated that 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. 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 Phase 1b study was a multi-center, randomized, double-blind,
placebo-controlled, multiple-ascending dose study. 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.
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 DyaxDyax is a biopharmaceutical company focused on
the development and commercialization of novel biotherapeutics for
unmet medical needs. The Company is developing DX-2930 for the
prevention of HAE attacks. Additionally, Dyax markets KALBITOR®
(ecallantide) for the treatment of acute attacks of HAE in patients
12 years of age and older.
Both DX-2930 and KALBITOR 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 trademark owned by or licensed to Eli Lilly
and Company, its subsidiaries, or affiliates.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150608005317/en/
Dyax Corp.Jennifer Robinson, 617-250-5741Director, Investor
Relations and Corporate Communicationsjrobinson@dyax.com
Dyax (NASDAQ:DYAX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Dyax (NASDAQ:DYAX)
Historical Stock Chart
From Apr 2023 to Apr 2024