Thursday, December 4, 2008

Alkermes starts trial of new dependency-fighting drug

By Mass High Tech Staff

Just days after announcing it had got back the rights to its alcohol-dependency-fighting drug Vivitrol, Cambridge biotech Alkermes Inc. reports that it has launched Phase 1 trials of its latest compound to fight addiction.

According to Alkermes officials, ALKS 33, an oral opioid modulator, is the company’s first novel, small molecule drug candidate to enter the clinic. The trial will use 16 healthy volunteers to assess the pharmacokinetics, safety and tolerability of ALKS 33 following single oral administration at increasing dosages.

Alkermes (Nasdaq: ALKS) launched the trials, officials said, because  preclinical studies showed ALKS 33 was better as an oral medication naltrexone, the compound that makes up Vivitrol, which is an injected drug.

On Monday, Alkermes and Cephalon Inc., a Frazer, Pa.-based biopharmaceutical firm, announced they had ended a collaboration agreement, returning all marketing and commercialization rights of alcohol anti-dependency medication Vivitrol back to Alkermes.

In April 2006, the U.S. Food and Drug Administration approved Vivitrol for the treatment of alcohol dependence. Alkermes, at the time, received a $110 million milestone payment from Cephalon following the FDA approval.

Alkermes is planning further preclinical studies of ALKS 33 for central nervous system disorders and has also started a Phase 1 study of ALKS 29, a potential oral treatment for alcohol dependence. The company says it expects to report first results from the ALKS 29 study in the first half of 2009.