Alkermes, Inc. (NASDAQ: ALKS) today announced positive topline data from a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). Data from the study showed that ALKS 37 was generally well tolerated and as predicted, demonstrated low systemic exposure across a wide range of doses. Based on these positive results, Alkermes expects to initiate a multi-dose phase 1 study in March 2010 as well as a phase 2 study to assess safety, tolerability and efficacy of ALKS 37 in individuals with OIC by the end of the first half of calendar 2010.
“We believe that these phase 1 data support our view that ALKS 37 may have a unique clinical profile because it targets the gastrointestinal tract and showed low systemic exposure”
The completed phase 1 study was a randomized, double-blind, placebo-controlled clinical trial that assessed the safety, tolerability and pharmacokinetics of a single oral administration of five ascending doses of ALKS 37, from 1 mg to 100 mg, in 40 healthy volunteers. At doses up to 100 mg there was low systemic exposure, consistent with prior preclinical results indicating that ALKS 37 targets the gastrointestinal tract with limited systemic exposure and little to no central nervous system (CNS) penetration. ALKS 37 was generally well tolerated in the phase 1 study and Alkermes plans to present the full results of the phase 1 study of ALKS 37 at a future medical meeting.
“We believe that these phase 1 data support our view that ALKS 37 may have a unique clinical profile because it targets the gastrointestinal tract and showed low systemic exposure,” said Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. “We look forward to continuing the recent momentum in our research and development efforts by initiating two additional clinical trials to generate further data, as we advance ALKS 37 as part of Alkermes’ growing pipeline of proprietary product candidates.”
Upcoming Studies of ALKS 37
Based on these positive phase 1 clinical results, Alkermes plans to initiate a phase 1 multi-dose study of ALKS 37 in March 2010. The study, ALK37-002, is a randomized, double-blind, placebo-controlled repeat dose study designed to assess the safety, tolerability and pharmacokinetics of daily oral administration of two dose levels of ALKS 37 for a seven day period in 24 healthy volunteers. These results will support the phase 2 clinical study, which is expected to begin in the first half of calendar 2010.
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