Myogen (NASDAQ:MYOG)
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From May 2019 to May 2024
Myogen, Inc. (Nasdaq: MYOG), a biopharmaceutical company
focused on the discovery, development and commercialization of small
molecule therapeutics for the treatment of cardiovascular disorders,
today announced the initiation of DORADO (DAR-311), an international
Phase 3 clinical trial to evaluate darusentan in patients with
resistant hypertension (RHTN). Myogen currently plans to initiate a
second international Phase 3 clinical trial, DAR-312, for the same
indication in the fourth quarter of this year. Contemporary clinical
guidelines define RHTN 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."
The primary objective of DORADO, a Phase 3 randomized,
double-blind, placebo-controlled parallel group trial, is to determine
if darusentan is effective in reducing systolic blood pressure in
resistant hypertension patients currently treated with full doses of
four or more antihypertensive medications, one of which is a diuretic.
Patients are eligible for enrollment in this trial if they have a
systolic blood pressure greater than or equal to 140 mmHg and no other
compelling conditions. For patients with diabetes and/or chronic
kidney disease, the blood pressure inclusion criterion is a systolic
blood pressure greater than 130 mmHg. Approximately 352 patients will
be randomized to one of three doses of darusentan (50, 100, or 300 mg
qd) versus placebo in a ratio of 7:7:7:11. The treatment period for
the trial is 14 weeks. The primary endpoint of the trial is change
from baseline to week 14 in trough sitting systolic blood pressure as
compared to placebo. Upon completion of the 14-week assessment period,
patients will be eligible to enroll in a long-term safety study.
Patients will be treated and followed for safety for at least six
months with a mean exposure expected to be in excess of one year.
About Darusentan
Darusentan is a non-sulfonamide, propanoic-acid class, type-A
selective endothelin receptor antagonist (ERA) being investigated in
clinical trials as an add-on oral therapy for patients with resistant
hypertension. Contemporary clinical guidelines define RHTN 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."
In August 2005, Myogen announced top line results of DAR-201, a
Phase 2b randomized, double-blind, placebo-controlled clinical trial.
The trial evaluated the effect of darusentan on systolic blood
pressure in 115 patients with RHTN. Results of the trial demonstrated
that 150 mg (at week 8) and 300 mg (at week 10) of darusentan dosed
once daily provided statistically significant placebo-corrected
reductions in systolic blood pressure measured by standard
sphygmomanometry, as well as 24-hour ambulatory blood pressure
monitoring (ABPM). Clinically meaningful reductions in systolic and
diastolic blood pressure were also observed at earlier time points at
lower doses. Trial results also demonstrated darusentan was generally
well tolerated. Additional results from the Phase 2b study were
presented at ACC.06, the 55th Annual Scientific Session of the
American College of Cardiology held in March 2006, and at the American
Society of Hypertension Annual Meeting held in May 2006.
About Myogen
Myogen has two product candidates in late-stage clinical
development: ambrisentan for the treatment of patients with pulmonary
arterial hypertension (PAH) and darusentan for the treatment of
patients with resistant hypertension. Myogen and GlaxoSmithKline have
entered into a global PAH collaboration in which Myogen has marketing
and distribution rights to GlaxoSmithKline's Flolan(R) (epoprostenol
sodium) for Injection in the United States and GlaxoSmithKline has
licensed ambrisentan from Myogen for all territories outside of the
United States, where Myogen retains exclusive rights. Myogen 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 www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that
involve significant risks and uncertainties, including the statements
relating to the potential of darusentan as a treatment for resistant
hypertension. Actual results could differ materially from those
projected and Myogen cautions investors not to place undue reliance on
the forward-looking statements contained in this release.
The results of Myogen's prior clinical trials of its product
candidates, including darusentan, do not necessarily predict the
results of future clinical trials. Preliminary results may not be
confirmed upon full analysis of the detailed results of a trial. There
can be no assurance that Myogen's product candidates, including
darusentan, have better safety profiles than competing products. Among
other things, Myogen's results may be affected by competition from
other pharmaceutical and biotechnology companies, Myogen's ability to
successfully develop and market its current products, difficulties or
delays in its clinical trials, regulatory developments involving
current and future products and its effectiveness at managing its
financial resources. If the Company's product candidates, including
darusentan, do not meet the 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 Myogen's product candidates
meet safety and efficacy endpoints, regulatory authorities may not
approve them, or the Company may face post-approval problems that
require the withdrawal of its products from the market. 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 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, 2005 and Myogen's periodic
reports on Form 10-Q and Form 8-K. Myogen is providing the information
contained in this release as of the date of the release and does not
undertake any obligation to update any forward-looking statements as a
result of new information, future events or otherwise.