Alkermes's ALKS 33 drug candidate offers potential treatment for multiple disease indications

Nov 17 2010

Alkermes, Inc. (NASDAQ: ALKS) today announced the presentation of promising preclinical results for its proprietary opioid modulator, ALKS 33, showing the drug candidate's potential in multiple disease indications. The data demonstrated ALKS 33 was effective in preventing olanzapine-associated weight gain and could potentially offer an adjunct therapy to patients with weight gain related to antipsychotic drug regimens. An additional data presentation showed that ALKS 33, regardless of the route of administration, effectively blocked elevations in nucleus accumbens dopamine following cocaine and amphetamine administration. A third presentation on ALKS 33 described the relationship between binge eating and reward disorders and the clinical rationale and endpoints of the ongoing clinical trial of ALKS 33 for the treatment of binge eating disorder. The data were presented at the 40^th Annual Meeting of the Society for Neuroscience in San Diego.

“We are excited to present data on ALKS 33, which demonstrate this drug candidate's broad utility”

"We are excited to present data on ALKS 33, which demonstrate this drug candidate's broad utility," stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "ALKS 33, which is moving forward in clinical trials in three disease indications, exemplifies Alkermes' strategy to advance its pipeline of next-generation therapeutics to address diseases in major markets, including central nervous system disorders and brain reward disorders, such as addiction, obesity and other impulse-control disorders."

Presentations given at the symposium include:

• A preclinical study evaluated the effects of ALKS 33 co-administered with olanzapine on olanzapine-induced weight gain in rodents. Results showed that ALKS 33 was effective in preventing olanzapine-induced weight gain while not inhibiting olanzapine's antipsychotic activity. Olanzapine, also known as ZYPREXA^®, is one of the most commonly prescribed antipsychotic medications, but it is also associated with clinically significant weight gain.
• A second preclinical study evaluated the efficacy of ALKS 33 on attenuating cocaine- and amphetamine-induced elevations of dopamine in the nucleus accumbens, a key region in the brain's reward pathway, and showed that both oral and subcutaneous administration of ALKS 33 were effective.
• A third presentation outlined the clinical rationale and endpoints of ALKS 33 for the treatment of binge eating disorder and detailed the design of the ongoing phase 2 proof-of-concept clinical study of ALKS 33 in 60 patients with binge eating disorder. Results from the phase 2 study are expected in the first half of calendar year 2011.

Source: Alkermes, Inc.