Neurocrine Biosciences Inc announced the initiation of a Phase II clinical trial with NBI-5788, an altered peptide ligand (APL) for the treatment of relapsing multiple sclerosis (MS). This multicenter, randomized, double blind, placebo-controlled trial will evaluate the safety and tolerability of 5 mg injections of NBI-5788 administered in five weekly doses followed by eight monthly doses for a total of nine months.
Additionally, it will investigate the disease-modifying effects of NBI-5788 using a summary change score for total gadolinium (Gd)-enhancing cranial Magnetic Resonance Imaging (MRI) lesions after nine months of treatment. The trial, led by principal investigator Dr. Jack Antel, Professor of Neurology at McGill University in Montreal, is being conducted in approximately 150 male and female patients with MS aged 18 to 55 years in approximately 25 study centers across the United States and Canada. Scientists of the Immune Tolerance Network (ITN), an international research consortium that aims to accelerate the clinical development of immune tolerance therapies for use in transplantation, autoimmune diseases and allergy and asthma, are partnering with Neurocrine to further investigate the immunological mechanisms of action of NBI-5788 in these patients with MS. The ITN is sponsored by the National Institute of Allergy and Infectious Diseases, with additional funds provided by the National Institute of Diabetes and Digestive and Kidney Diseases and the Juvenile Diabetes Research Foundation.
A prior Phase II study of NBI-5788 involving doses of 5 mg, 20 mg and 50 mg suggested clinical improvement in patients who were administered the lowest dose (5 mg). Based on the results from this earlier study, this new trial will further define the efficacy and safety of NBI-5788 at the 5 mg dose compared with placebo.
"We are extremely encouraged by the continued involvement of lead investigators from our previous clinical program with NBI-5788 along with the new support of the National Institutes of Health (NIH) for developing this novel class of compound as a specific immune therapy for MS," said Gary Lyons, President and Chief Executive Officer of Neurocrine Biosciences. "The possibility of a less frequently administered therapy may hold significant advantages for patients enduring this chronic illness. Results from this second Phase II trial are expected in 2005."