Neurocrine says APL technology for multiple sclerosis fails phase 2 study; program discontinued

By E. Janene Geiss

Philadelphia, March 8 - Neurocrine Biosciences, Inc. announced Wednesday that the results of its phase 2 clinical trial using its altered peptide ligand (APL) technology for multiple sclerosis did not meet its primary endpoint and demonstrate efficacy although the product was safe and well-tolerated.

Based on these results, the company said it has discontinued the development of its APL-MS program, according to a company news release.

The company said it will complete its other APL phase 2 study, which is evaluating the APL technology for the treatment of type 1 diabetes using a different APL epitope. Results of this trial are expected in the third quarter of 2006.

"Our phase 2 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 9-month treatment period," Wendell Wierenga, executive vice president of research and development for Neurocrine, said in the release.

"Antigen specific recruitment of TH2 cells to treat autoimmune disorders is a very appealing concept. We will continue to evaluate the clinical benefits of the APL epitope to treat type 1 diabetes and will review this program based on phase 2 results expected mid-year."

In other developments, the company said it continues to anticipate that the proposed rule in the Federal Register for the Drug Enforcement Agency to place indiplon into schedule IV of the Controlled Substances Act is expected to occur shortly.

This proposed action will be based on a recommendation from the acting assistant secretary for health of the Department of Health and Human Services and on an evaluation of the relevant data by the agency, officials said.

Based on discussions with the DEA, the company said it expects the agency will complete its process in parallel with the FDA review.

In addition, the company reported on the progress of the other clinical development goals for 2006.

Neurocrine said it is focusing on the advancement of several programs from early to mid-stage clinical development for multiple therapeutic indications.

The company's main clinical development candidates include an oral, small-molecule GnRH antagonist for the treatment of endometriosis and benign prostate hyperplasia, urocortin 2 for congestive heart failure and a CRF antagonist for anxiety/depression and irritable bowel syndrome, officials said.

The company also said it is advancing a back-up compound for GnRH and has brought forward into clinical development a back-up CRF antagonist.

In addition, the company said it has begun a phase 1 clinical trial for a new compound, an H1 antagonist, NBI-75043, for the treatment of insomnia.

Neurocrine is a San Diego product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders.

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