Primary Endpoint Achieved With 11.6 mmHg Reduction in Systolic Blood Pressure
DENVER, Aug. 18 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG)
today announced positive top line results of its Phase 2b trial evaluating
darusentan in resistant hypertension. Results of the trial demonstrated that
300 mg of darusentan dosed once daily provided statistically significant,
placebo-corrected reductions of 11.6 mmHg (p=0.02) in systolic blood pressure
and 7.0 mmHg (p<0.001) in diastolic blood pressure. Clinically meaningful
reductions in systolic and diastolic blood pressure were also observed at
earlier time points at lower doses. Trial results demonstrated darusentan was
generally well tolerated suggesting a favorable safety profile. There were no
observed serum aminotransferase concentrations above two times the upper limit
of the normal range. Based on these results, the Company plans to move
forward with Phase 3 clinical development of darusentan for the treatment of
resistant hypertension.
"We are highly encouraged by the results of this trial," said J. William
Freytag, President and Chief Executive Officer of Myogen. "There are millions
of hypertensive patients in the United States currently being treated with
three or more antihypertensive therapies. A significant percentage of these
patients are not at goal blood pressures and are at increased risk of
cardiovascular events. As an endothelin receptor antagonist, darusentan
affects blood pressure through a mechanism of action different than those of
currently approved antihypertensive drugs. The results of this trial indicate
darusentan could provide additional blood pressure lowering benefit in this
patient population. This positive outcome advances our mission to improve the
quality of life of patients who suffer from debilitating cardiovascular
disorders."
"These results are particularly gratifying considering that these patients
were already on full doses of three antihypertensive medications including a
diuretic," commented Michael J. Gerber, M.D., Senior Vice President, Clinical
Development and Regulatory Affairs. "To the best of our knowledge, no other
antihypertensive agent has ever been shown to have efficacy in this setting.
This outcome supports our optimism that darusentan has the potential to
improve the treatment options available to physicians trying to manage this
complex disorder. We look forward to initiating a Phase 3 program to evaluate
darusentan in a larger, international patient population."
About DAR-201
The primary objective of this Phase 2b randomized, double-blind,
placebo-controlled trial was to determine if darusentan is effective in
reducing systolic blood pressure in patients with resistant hypertension.
Patients were eligible for enrollment in this trial if they had a systolic
blood pressure greater than or equal to 140 mmHg and a diastolic blood
pressure greater than 90 mmHg despite treatment with full doses of three
anti-hypertensive medications, one of which was a diuretic, and no other
compelling conditions. For patients with diabetes and chronic renal disease,
systolic and diastolic blood pressures inclusion criteria were more stringent,
namely a systolic blood pressure greater than 130 mmHg and a diastolic blood
pressure greater than 80 mmHg. A total of 115 patients were randomized to
darusentan or placebo at approximately 30 investigative sites in the U.S.
Patients underwent forced titration every two weeks through 10, 50, 100 and
150 mg of darusentan or placebo until the target dose of 300 mg once daily was
achieved. The treatment period was ten weeks followed by a two week drug
withdrawal period.
About Resistant Hypertension
Hypertension affects approximately 50 million individuals in the United
States and approximately one billion worldwide. Despite the availability and
use of several classes of drugs (diuretics, ACE inhibitors, angiotensin
receptor blockers, beta-blockers, calcium channel blockers, central alpha
receptor agonists, peripheral alpha antagonists and vasodilators) to treat
hypertension, a significant percentage of these patients (20-30% according to
recently published data) fail to achieve blood pressures within the
recommended range.
The "Seventh Report of the Joint National Committee on Prevention,
Detection, Evaluation and Treatment of High Blood Pressure" (JNC7) defines
resistant hypertension as "the failure to achieve goal blood pressure in
patients who are adhering to full doses of an appropriate three-drug regimen
that includes a diuretic." According to JNC7, a systolic blood pressure of
less than 140 mmHg and a diastolic blood pressure of less than 90 mmHg are
recommended for patients with hypertension and no other serious conditions.
For patients with diabetes and chronic renal disease, target systolic and
diastolic blood pressures are more stringent -- a systolic blood pressure goal
of less than 130 mmHg and a diastolic blood pressure goal of less than 80
mmHg.
About Darusentan
Darusentan is a type-A selective endothelin receptor antagonist (ERA) and
potent inhibitor of endothelin-induced vasoconstriction. Endothelin is a
small peptide hormone that is believed to play a critical role in the control
of blood flow and cell growth. Elevated endothelin blood levels are
associated with several cardiovascular disease conditions, including
hypertension, pulmonary arterial hypertension, chronic renal disease, coronary
artery disease and chronic heart failure. Therefore, the Company believes
that agents that block the detrimental effects of endothelin may provide
significant benefits in the treatment of these conditions. Darusentan
demonstrates high potency, high bioavailability and a half-life we believe is
suitable for once daily dosing. In a prior clinical study in patients with
moderate essential hypertension, darusentan demonstrated statistically
significant and clinically meaningful dose-dependent reductions in systolic
and diastolic blood pressures.
Conference Call
J. William Freytag, President and CEO, and other members of Myogen's
senior management will discuss the darusentan results via webcast and
conference call on Thursday, August 18, 2005 at 8:30 am Eastern. To access
the live webcast, please log on to the Company's website at http://www.myogen.com and
go to the Investor Relations section. Alternatively, callers may participate
in the conference call by dialing 800-866-5043 (domestic) or 303-262-2141
(international). Webcast and telephone replays of the conference call will be
available approximately two hours after the completion of the call through
Friday, September 2, 2005. Callers can access the replay by dialing
800-405-2236 (domestic) or 303-590-3000 (international). The passcode is
11037845#.
About Myogen
Myogen is a biopharmaceutical company focused on the discovery,
development and commercialization of small molecule therapeutics for the
treatment of cardiovascular disorders. Myogen currently markets one product
in Europe for the treatment of acute decompensated heart failure and has two
product candidates in late-stage clinical development: ambrisentan for the
treatment of patients with pulmonary arterial hypertension and darusentan for
the treatment of patients with resistant hypertension. The Company also
conducts a target and drug discovery research program focused on the
development of disease-modifying drugs for the treatment of chronic heart
failure and related cardiovascular disorders. Please visit Myogen's website
at http://www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that involve
significant risks and uncertainties, including summary statements relating to
the top line results of the Company's darusentan Phase 2b clinical trials and
statement relating to the efficacy and safety profile of darusentan and the
Company's intent to initiate Phase 3 clinical development of darusentan for
the treatment of resistant hypertension. Actual results could differ
materially from those projected and the Company cautions investors not to
place undue reliance on the forward-looking statements contained in this
release.
Results from clinical trials, including the Company's Phase 2b trial of
darusentan, are not necessarily predictive of future clinical results. Top
line results may not be confirmed upon full analysis of the detailed results
of a trial and additional information relating to the safety, efficacy or
tolerability of the Company's product candidates, including darusentan, may be
discovered upon further analysis of trial data. If the Company's product
candidates do not meet safety or efficacy endpoints in clinical evaluations,
they will not receive regulatory approval and the Company will not be able to
market them. Even if the Company's product candidates meet safety and
efficacy endpoints, regulatory authorities may not approve them, the Company
may not be able to successfully market them, or the Company may face
post-approval problems that require the withdrawal of its product from the
market. There can be no assurance that Myogen's product candidates, including
darusentan, will be proven safe and effective for use in humans. Abnormal
elevations of liver function test results, including elevated serum
aminotransferase concentrations, have been reported in trials of other
endothelin receptor antagonists. The Company's results may be affected by its
effectiveness at managing its financial resources, its ability to successfully
develop and market its product candidates, competition from other
biotechnology and pharmaceutical companies, difficulties or delays in
manufacturing its products, and regulatory developments involving current and
future products. Delays in clinical trials, whether caused by competition,
adverse events, patient enrollment rates, regulatory issues or other factors,
could adversely affect the Company's financial position and prospects. If the
Company is unable to raise additional capital when required or on acceptable
terms, it may have to significantly delay, scale back or discontinue one or
more of its drug development or discovery research programs. Myogen is at an
early stage of development and may not ever have any products that generate
significant revenue.
Additional risks and uncertainties relating to the Company and its
business can be found in the "Risk Factors" section of Myogen's Form 10-K for
the year ended December 31, 2004 and Myogen's reports on Form 10-Q and Form
8-K. It is Myogen's policy to only update or reconfirm its public guidance by
issuing a press release or filing a periodic or current report with the
Securities and Exchange Commission. The Company generally plans to provide
guidance as part of its annual and quarterly earnings releases but reserves
the right to provide guidance at different intervals or to revise its practice
in future periods. All information in this press release is as of August 18,
2005. Myogen undertakes no duty or obligation to update any forward-looking
statements contained in this release as a result of new information, future
events or changes in the Company's expectations. The Company also disclaims
any duty to comment upon or correct information that may be contained in
reports published by the investment community.
SOURCE Myogen, Inc.
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Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations
of Myogen, Inc. +1-303-464-3986, derek.cole@myogen.com
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