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news.Following the failure of its altered peptide ligand technology for multiple sclerosis to meet its primary efficacy endpoint in a phase II trial, Neurocrine Biosciences has decided to discontinue development of the program.
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The company will, however, complete its other altered peptide ligand (APL) phase II study, which is evaluating the technology for the treatment of type-1 diabetes, utilizing a different APL epitope. Results of this trial are expected in the third quarter of 2006.
“Our phase II study in multiple sclerosis patients showed APL-MS to have an excellent safety profile, but unfortunately the study did not achieve statistical significance in efficacy in the 157 patients tested over the nine-month treatment period,” said Dr Wendell Wierenga, executive vice president of R&D for Neurocrine Biosciences.
Meanwhile, the company’s insomnia treatment Indiplon, to be co-marketed with Pfizer, is currently under review as a controlled substance by the Drug Enforcement Administration. The DEA review is occurring alongside the usual FDA marketing authorization regulatory process. The company said it believes the evaluations will both be completed shortly.