— Company Continues to Advance Clinical Pipeline —
“The advancement of ALKS 33 in the clinic is an important step as we
continue to build our proprietary pipeline, which is based on drugs that
we believe have a high likelihood of clinical and commercial success,”
stated
The phase 2 study is designed to assess the safety and efficacy of ALKS 33 in patients with alcohol dependence. In this multi-center, double-blind, placebo-controlled study, up to 440 patients will be randomized to receive daily oral administrations of one of three doses of ALKS 33 or placebo for a total of 12 weeks of treatment. The phase 2 study has an adaptive study design which enables an interim analysis after 40 percent of the patients are enrolled and on medication for eight weeks of treatment. The efficacy of ALKS 33 will be evaluated based on the percentage of patients who are abstinent from heavy drinking during the eight-week evaluation phase. Heavy drinking is defined as five or more drinks per day for men and four or more drinks per day for women. The pharmacokinetics and safety of ALKS 33 will also be evaluated.
About ALKS 33
ALKS 33 is an oral opioid modulator that builds on Alkermes’ unique
understanding of biological pathways and opioid pharmacology as well as
the company’s clinical and commercial knowledge in the field of
addiction. In
About Opioid Modulators
Opioid modulators can act as agonists, antagonists or partial agonists at opioid receptors throughout the body. Emerging biological research and new medicinal chemistry insights now allow for the development of novel opioid modulators with the potential to show enhanced activity at opioid receptor sites and could ultimately lead to improved therapeutic options.
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 potential
therapeutic and commercial value of Alkermes’ proprietary molecules
targeting opioid receptors, including ALKS 33; the potential success of
the Phase 2 study of ALKS 33 and Alkermes’ plans to continue development
of such proprietary molecules. 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. 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 phase 2
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 33 will demonstrate sufficient efficacy and safety;
and decisions by the
VIVITROL® is a registered trademark of
Source:
Alkermes, Inc.
For Investors:
Rebecca Peterson, 617-583-6378
or
For
Media:
Jennifer Snyder, 617-583-6166