Alkermes Initiates Phase 1 Clinical Study Of ALKS 37

Alkermes has initiated 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).

Reportedly, the randomised, 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 that 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.

Additionally, the 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.

Daniel Deaver, vice president of non-clinical development of Alkermes, said: “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. 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.”

Elliot Ehrich, chief medical officer of Alkermes, said: “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. Today’s announcement is a testament to our advancing proprietary pipeline.”