10.06.2009 11:39:00
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Amarin Announces Results from Exploratory Phase 2a Study of EN101 in Myasthenia Gravis
Amarin Corporation plc (NASDAQ:AMRN) today announced encouraging top line results from an exploratory Phase 2a multi-centre, dose-ranging, cross-over clinical study of EN101 in patients with myasthenia gravis, a chronic autoimmune disease characterized by muscle weakness which can be life-threatening.
Thomas Lynch, Chairman and Chief Executive Officer of Amarin, commented "We are pleased to announce this update regarding the EN101 program. EN101 is one of our CNS assets that we plan to partner as a consequence of the Company’s recent focusing of development efforts on cardiovascular disease programs. We expect this data will be of interest to any future potential partners.”
Dr. Declan Doogan, Head of Research and Development of Amarin, added "The results from this exploratory Phase 2a study support the further clinical evaluation of EN101 in myasthenia gravis.”
The primary objective of the exploratory study, for which interim results had previously been announced, was to assess the efficacy and safety of three doses of EN101 each given orally once daily for one week in patients with myasthenia gravis. The final results of the study indicate that 10mg, 20mg and 40mg of EN101 resulted in a statistically significant reduction in Quantitative Myasthenia Gravis (QMG) score from baseline of 11.8% (p=0.001), 16.8% (p<0.001) and 20.3% (p<0.001), respectively. Importantly, EN101 was also shown to be safe and well tolerated.
The 31-patient study was performed in six centers in the U.K., Israel and Serbia. Each dose of EN101 was administered to patients for one week and was separated by a one week wash-out on pyridostigmine, often the first-line treatment for myasthenia gravis. Efficacy was assessed by evaluating changes in the QMG score, an established questionnaire that evaluates signs and symptoms of myasthenia gravis.
Amarin also announced that it has amended the Ester Neurosciences Limited ("Ester”) acquisition agreement entered into in December 2007. The amendments, which reflect Amarin’s intention to seek a partner for EN101, provide for the release of Amarin from research and development diligence obligations contained in the original agreement, with remaining contingent milestones only being payable from fees and milestones received from any future partners. As part of the amended agreement, Amarin will issue 1,315,789 ordinary shares to the former Ester shareholders.
About EN101
EN101 is an orally delivered oligonucleotide
with complementary mechanisms of action. As an antisense agent it
preferentially suppresses the "read-through" or "R" isoform (AChE-R) of
acetylcholinesterase (AChE). This is believed to enhance neuromuscular
functioning while avoiding the negative cholinergic effects currently
observed with conventional, non-selective acetylcholinesterase
inhibitors. EN101 also acts on re-balancing innate immunity features,
which are often impaired by conventional acetylcholinesterase
inhibitors. By elevating acetylcholine levels EN101 further reduces
circulating pro-inflammatory cytokines through the "cholinergic
anti-inflammatory reflex".
EN101 and its underlying technology are protected by a number of issued patents and pending applications in a number of territories worldwide, including the U.S. and Europe. EN101 has been granted orphan drug designation for the treatment of myasthenia gravis by the U.S. Food and Drug Administration and by the European Medicines Agency.
About Myasthenia Gravis
Myasthenia gravis (MG) is the most
common primary disorder of neuromuscular transmission. It is a chronic
autoimmune neuromuscular disease characterized by varying degrees of
weakness of the skeletal (voluntary) muscles of the body. About 10% of
MG patients develop a life-threatening weakness of the respiratory
muscles needed for breathing, a condition called myasthenic crisis. MG
occurs in all races, both genders and at all ages. According to the
Myasthenia Gravis Foundation of America, the prevalence of MG is
estimated at 14 to 20 per 100,000 population, with up to 60,000 cases in
the U.S.
About Amarin
Amarin is a late-stage
biopharmaceutical company with a focus on cardiovascular disease. The
Company’s lead product candidate is AMR101, a prescription grade Omega-3
fatty acid comprising not less than 96% ultra-pure ethyl
eicosapentaenoic acid (EPA), which is entering Phase 3 clinical trials
for the treatment of hypertriglyceridemia under a Special Protocol
Assessment (SPA) agreement with the U.S. Food and Drug Administration
(FDA). Amarin recently established its research and development
headquarters in Mystic, Connecticut with an experienced research and
development team. Amarin’s programs capitalize on its lipid science
expertise and the known therapeutic benefits of Omega-3 fatty acids in
treating cardiovascular disease. The pipeline also includes proprietary
next-generation lipid candidates, currently at preclinical stages of
development.
Amarin has a range of clinical and preclinical stage compounds to treat central nervous system (CNS) disorders, including Huntington’s disease, myasthenia gravis, Parkinson’s disease and epilepsy, all of which are available for partnering. Amarin is listed in the U.S. on the Nasdaq Capital Market ("AMRN”). For more information please visit www.amarincorp.com.
Disclosure Notice
The information contained in this
document is as of June 10, 2009. Amarin assumes no obligation to update
any forward-looking statements contained in this document as a result of
new information or future events or developments. This document contains
forward-looking statements about Amarin's results of operations,
business prospects and products in research that involve substantial
risks and uncertainties. You can identify these statements by the fact
that they use words such as "will", "anticipate", "estimate", "expect",
"project", "forecast", "intend", "plan", "believe" and other words and
terms of similar meaning in connection with any discussion of future
operating or financial performance or events. Among the factors that
could cause actual results to differ materially from those described or
projected herein are the following: Amarin's ability to maintain
sufficient cash and other liquid resources to meet its operating and
debt service requirements; the success of Amarin's research and
development activities; decisions by regulatory authorities regarding
whether and when to approve Amarin's drug applications, as well as their
decisions regarding labeling and other matters that could affect the
commercial potential of Amarin's products; the speed with which
regulatory authorizations, pricing approvals and product launches may be
achieved; whether and when Amarin will be able to enter into and
consummate strategic collaborations with respect to its products or
product candidates on acceptable terms; the success with which developed
products may be commercialized; Amarin's ability to protect its patents
and other intellectual property; and claims and concerns that may arise
regarding the safety or efficacy of Amarin's products or product
candidates. A further list and description of these risks, uncertainties
and other matters can be found in Amarin's Form 20-F for the fiscal year
ended December 31, 2007, filed with the SEC on May 19, 2008 and Amarin's
Form 20-F/A for the fiscal year ended December 31, 2007 filed with the
SEC on September 24, 2008.
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