Alkermes Initiates Two New Clinical Trials Of ALKS 33

Main Category: Alcohol / Addiction / Illegal Drugs
Also Included In: Clinical Trials / Drug Trials
Article Date: 15 May 2009 - 0:00 PDT

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Alkermes, Inc. (NASDAQ: ALKS) announced the initiation of two new clinical trials of ALKS 33, an oral opioid modulator for the potential treatment of addiction and other nervous system disorders. Study ALK33-004 is a phase 1 clinical trial designed to examine the ability of ALKS 33 to block the effects of an opioid following a single oral dose of ALKS 33 in healthy, non-dependent, opioid-experienced subjects. Study ALK33-003 is a phase 1 clinical trial designed to evaluate the pharmacokinetics, safety and tolerability of multiple doses of ALKS 33 in healthy volunteers.

The initiation of these studies follows the successful completion of a phase 1 dose escalation study of ALKS 33 in healthy volunteers. Alkermes expects to report data from both ALK33-004 and ALK33-003 in the second half of calendar 2009.

"ALKS 33 is an excellent example of how Alkermes is leveraging its new insights about opioid receptor pathways to develop medications with unique advantages over currently available therapies," stated Elliot Ehrich, M.D., chief medical officer at Alkermes. "We expect to use the data from these additional phase 1 studies to shape our plans for phase 2 clinical development."

ALKS 33 Study Designs

ALK33-004 is a phase 1, randomized, single-blind, placebo-controlled, single-dose study designed to test the ability of ALKS 33 to block the effects of an opioid agonist, remifentanil, a commercially available analgesic. Approximately 24 healthy, non-dependent, opioid-experienced subjects will be randomized to receive a placebo dose as well as one of two dose levels of ALKS 33. The ability of ALKS 33 to block the effects of remifentanil will be measured by pupillometry assessments and subjective measures of opioid effects. The pharmacokinetics and safety of ALKS 33 will also be evaluated.

ALK33-003 is a phase 1 randomized, double-blind, placebo-controlled, multi-dose study designed to assess the steady-state pharmacokinetics, safety and tolerability of ALKS 33. Approximately 30 healthy subjects will be randomized to receive seven consecutive, daily oral doses of one of two dose levels of ALKS 33 or placebo.

About ALKS 33

ALKS 33 is an oral opioid modulator that builds on Alkermes' scientific expertise in brain reward pathways as well as the company's clinical and commercial knowledge in the field of addiction. In April 2009, Alkermes presented topline data from a phase 1 randomized, double-blind, placebo-controlled study of ALKS 33 in 16 healthy volunteers. Data from the study showed that ALKS 33 was generally well tolerated and demonstrated rapid oral absorption, high plasma concentrations and duration of action that supports once daily dosing. The study results are consistent with previous findings that ALKS 33 is not metabolized by the liver, a unique advantage over existing oral therapies for addiction.

About Opioid Receptor Pathways

Opioid receptor pathways have biological activity throughout the body including the brain, gastrointestinal system, immune system and cardiovascular system. Consequently, opioid receptor pathways play a key role in a broad range of nervous system disorders such as pain, addiction, psychiatric disorders, gastrointestinal disorders and immune disorders. 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.

Source
Alkermes