|Alkermes Chief Medical Officer Elliot Ehrich|
Alkermes ($ALKS) has pulled the plug on an abuse-deterrent pain medication after it came up short in early testing, pivoting its focus to some preclinical analgesics.
The drug, ALKS 7106, is an oral opioid drug designed to discourage abuse and slash the risk of overdose with a novel mechanism of action. Instead of using controlled-release technologies like other drug developers, Alkermes fashioned a candidate whose chemistry put an intrinsic ceiling on its effects, the company said, and preclinical data showed the drug had similar efficacy to morphine at a roughly 30-fold lower dose.
But, in a first-in-human clinical trial on 64 patients, ALKS 7106 failed to meet Alkermes prespecified criteria for advancing into Phase II, and the company has scrapped the program altogether. Alkermes didn't disclose just how the drug came up short, noting only that it was testing for safety, tolerability and pharmacokinetics in the Phase I trial.
Despite the setback, the CNS-focused Alkermes is still committed to the pain-management space, and Chief Medical Officer Elliot Ehrich said the company is unafraid to kill its darlings, moving on from ALKS 7106 and onto the identification and development of new candidates in the field.
"Our decision with ALKS 7106 exemplifies Alkermes' approach to drug development, in which we conduct highly informative studies and set prespecified criteria that drive our disciplined decisions for whether to proceed or halt investment in candidates early in the development process," Ehrich said in a statement.
Meanwhile, Alkermes is barreling ahead with ALKS 8700, an oral multiple sclerosis treatment designed to compete with Biogen Idec's ($BIIB) blockbuster Tecfidera. The biotech is largely focused on therapeutics that allow it to use its know-how in drug delivery and novel formulations to improve upon best-selling drugs, CEO Richard Pops has said, a philosophy that extends to its later-stage pipeline, highlighted by the schizophrenia treatment ALKS 3831 and depression drug ALKS 5461.
- read the statement