Alkermes Announces Initiation Of Phase 1 Clinical Study Of ALKS 37 For The Treatment Of Opioid-Induced Constipation

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Clinical Trials / Drug Trials;  Pain / Anesthetics
Article Date: 28 Oct 2009 - 6:00 PDT

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Alkermes, Inc. (NASDAQ: ALKS) announced the initiation of a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the opioid agonist effects on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetic effects of a single oral administration of five doses of ALKS 37 in approximately 40 healthy volunteers. Preclinical studies have shown ALKS 37 targets the gastrointestinal tract following oral administration, with limited systemic exposure. ALKS 37 is a component of ALKS 36, a combination drug candidate for the treatment of pain without the side effects of constipation.

According to IMS Health, over 200 million prescriptions were written for opioids in 2007 in the United States. Many studies indicate that a high percentage of patients receiving opioids are likely to experience side effects affecting gastrointestinal motility.

"While opioids are a common and effective treatment for managing chronic pain, the side effects of these medications can be debilitating and may diminish patient adherence to pain medication," stated Daniel Deaver, Ph.D., Vice President, Non-Clinical Development of Alkermes. "We are excited to bring forward ALKS 37 into the clinic as it has the potential to enable the use of pain medications without inhibiting gastrointestinal motility."

"Our unique understanding of opioid biology and pharmacology allowed us to take a very innovative approach to the development of a GI-targeted therapy such as ALKS 37," said Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. "Today's announcement is a testament to our advancing proprietary pipeline."

ALKS 37 Study Design

The phase 1 study of ALKS 37 is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability and pharmacokinetic effects of a single oral administration of five doses of ALKS 37 in approximately 40 healthy volunteers. Initiation of this trial is based on preclinical studies that showed ALKS 37 demonstrated the potential to reverse opioid agonist effects on gastrointestinal motility with low systemic exposure and little or no CNS penetration. Preclinical data also showed that oral administration of ALKS 37 had greater efficacy at a lower dose and for an extended period of time compared to an active comparator, methylnaltrexone. The company expects to report top-line results from the study in the first half of calendar 2010.

In addition to ALKS 37, Alkermes is developing ALKS 36, an oral co-formulation of an opioid analgesic and ALKS 37. A pain medication that does not inhibit gastrointestinal motility, such as ALKS 36, may provide a unique advantage over current therapies.

About Opioid Modulators

Opioid modulators can act as antagonists, agonists 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 receptors and could ultimately lead to improved therapeutics.

Source
Alkermes, Inc.