Recently, Alkermes Inc. (ALKS) announced encouraging topline data from an early-stage study of its candidate of ALKS 37. ALKS 37 is an orally active, peripherally-restricted opioid antagonist having the potential to block the effects of opioid agonists on gastrointestinal motility, commonly termed as opioid-induced constipation (OIC). Alkermes intends to present full results from the early-stage study at a future medical meeting.
The randomized, double-blind, placebo-controlled study evaluated the safety, tolerability and pharmacokinetics of a single oral administration of 5 ascending doses of the candidate, ranging from 1 mg to 100 mg, in 40 healthy volunteers. The data revealed the presence of low systemic exposure at doses up to 100 mg. The finding was consistent with prior preclinical studies which showed that ALKS 37 targets the gastrointestinal tract with limited systemic exposure coupled with little to no central nervous system penetration.
The study also revealed that the candidate was generally well tolerated. The encouraging results from the study have prompted the company to initiate a multi-dose early-stage study (ALK37-002) probably in March 2010.
The randomized, double-blind, placebo-controlled repeat dose study (n=24) will assess the safety, tolerability and pharmacokinetics of daily oral administration of two dosages of ALKS 37 for a week. Furthermore, Alkermes intends begin a mid-stage study to assess safety, tolerability and efficacy of ALKS 37 in patients suffering from OIC by the end of the first half of calendar 2010.
We remind investors that a key action date for Alkermes is coming up on March 5, 2010 when the U.S. Food and Drug Administration (FDA) decides on its type II diabetes candidate, exenatide once-weekly which Alkermes has co-developed with Eli Lilly (LLY) and Amylin Pharmaceuticals, Inc. (AMLN).
Going forward, investor focus will remain on the approvability of exenatide once-weekly. While the efficacy data on exenatide once-weekly is impressive, we believe that its approval may get delayed because of fears of pancreatitis and thyroid cancer associated with the use of glucagon-like peptide-1 (GLP-1) molecules (like exenatide).
Alkermes currently has a Zacks Rank #3 (Hold), implying that the stock is expected to perform in line with the broader U.S. equity market over the next one to three months. We are Neutral on the company in the long-term as well. The Neutral recommendation implies that the stock is expected to perform in line with the overall U.S. equity market over the next six to twelve months. Therefore, we advise investors to retain the stock over this time period.
Read the full analyst report on “ALKS”
Read the full analyst report on “LLY”
Read the full analyst report on “AMLN”
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