This phase 2a study follows completion of a previous clinical study in patients with COPD, which showed that single doses of ALKS 27 demonstrated a rapid onset of action and produced a significant improvement in lung function (p<0.0001) over 24 hours compared to placebo.
The fourth leading cause of death in the U.S., COPD is a serious, chronic disease characterized by a gradual loss of lung function. It is estimated that over 12 million adults have been diagnosed with COPD and approximately 24 million adults have evidence of impaired lung function, indicating COPD is significantly underdiagnosed. As an inhaled formulation of trospium, a muscarinic receptor antagonist that relaxes smooth muscle tissue, ALKS 27 could potentially improve airflow and provide a new treatment option for patients with COPD.
"We are excited to move forward with the ALKS 27 program, one of several
proprietary product candidates in our advancing pipeline," stated
The phase 2a study is designed to assess the efficacy, safety, tolerability and pharmacokinetics of ALKS 27 in approximately 24 patients with COPD. In this randomized, double-blind, cross-over, placebo-controlled study, patients will receive single administrations of three doses of ALKS 27 and placebo, each separated by a wash out period. The efficacy of ALKS 27 will be evaluated based on improvements in pulmonary function in patients with COPD, as measured by FEV1, a commonly used measure of lung function.
In addition, the phase 2a study will explore the safety, tolerability
and effects of ALKS 27 in combination with formoterol fumarate
inhalation powder, a long-acting beta agonist (LABA) already approved
for the treatment of COPD. All patients will receive the combination
dose following the randomized, double-blind, placebo-controlled portion
of the study. Research indicates that LABAs and muscarinic receptor
antagonists, such as ALKS 27, may have a synergistic effect on improving
symptoms in patients with COPD by acting on complementary pathways.1
About
Certain statements set forth above may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to the development
activities for ALKS 27 and the therapeutic potential of ALKS 27 in COPD.
Although the company believes that such statements are based on
reasonable assumptions within the bounds of its knowledge of its
business and operations, the forward-looking statements are neither
promises nor guarantees and the company's business is subject to
significant risk and uncertainties and there can be no assurance that
its actual results will not differ materially from its expectations.
These risks and uncertainties include, among others: whether the
clinical trial discussed in this release will be completed on time or at
all; potential changes in cost, scope and duration of the clinical
trial; whether ALKS 27 will be further developed; and whether ALKS 27
for the treatment of COPD will be approved by regulatory authorities and
subsequently commercialized. For further information with respect to
factors that could cause the company's actual results to differ
materially from expectations, reference is made to the reports the
company filed with the
AIR® is a registered trademark of
1
Source:
Alkermes, Inc.
For Investors:
Rebecca Peterson, 617-583-6378
or
Jaren
Madden, 617-583-6402
or
For Media:
Eva Stroynowski,
617-583-6823