Alkermes, Inc. (NASDAQ: ALKS) today announced preliminary results from a phase 2 clinical study of ALKS 33, one of Alkermes' proprietary candidates for the treatment of reward disorders and other central nervous system (CNS) disorders. The 12-week study was designed to assess the safety and efficacy of daily oral administration of three different dose levels of ALKS 33 compared to placebo in 400 alcohol dependent patients. In addition to more traditional measurements of efficacy, the study also tested a new efficacy endpoint previously untested in a clinical trial, which was a measurement of complete abstinence from heavy drinking. The preliminary results of the study showed that once daily administration of ALKS 33 was generally well tolerated at all three dose levels. While the difference in complete abstinence from heavy drinking between treatment groups did not reach statistical significance, patients treated with all three doses of ALKS 33 demonstrated a significant reduction in heavy drinking days in a dose dependent manner compared to placebo. Patients on the highest dose of ALKS 33 showed the greatest relative reduction in heavy drinking days of 41% compared to placebo.
"ALKS 33 was well tolerated and showed a clear effect in reducing heavy drinking in this clinical trial. This study provides a large data set, which reinforces the potential clinical attributes of ALKS 33 and supports its expanded clinical development as an oral opioid modulator with potential utility in the treatment of a wide range of CNS disorders," said Dr. Elliot Ehrich, Chief Medical Officer of Alkermes.
ALKS 33 is characterized by its potential for daily dosing, non-hepatic metabolism, extended pharmacologic benefit in the event of missed doses and pharmacologic activity in modulating brain opioid receptors. ALKS 33 is currently being evaluated in clinical trials as a potential treatment for binge eating disorder and, in combination with buprenorphine, for cocaine addiction and potentially other disorders. Alkermes plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the results of this phase 2 study and the potential endpoints for a phase 3 clinical study.