EXTON, Pa.--(Nuron Biotech Inc., a specialty biologics and vaccines company, today announced the completion of enrollment in its randomized, double-blind, placebo-controlled, parallel-group, pivotal Phase 3 study to evaluate the safety and efficacy of NU100 for the treatment of relapsing remitting multiple sclerosis (RRMS). This pivotal Phase 3 study is expected to be filed in support of the European marketing authorization application (MAA) in early 2014. NU100 is a proprietary recombinant human interferon beta-1b being developed as a new chemical entity. Produced utilizing an advanced processing technology, the liquid product formulation is virtually aggregate-free and human serum albumin-free (HSA-free), which may result in lower immune responses, potentially improving overall long-term clinical efficacy and improving the tolerability and safety for RRMS patients presently requiring therapy with interferon beta-1b.)--
“Millions of patients worldwide suffer from multiple sclerosis. If successful in this clinical study, NU100 offers these patients and their families the promise of another important treatment option for RRMS”
“The rapid completion of enrollment in NU100’s Phase 3 study is an important milestone for Nuron Biotech and our lead development program,” said Shankar Musunuri, Ph.D., MBA, Chief Executive Officer and Founder of Nuron Biotech. “We are pleased with the positive progress we are making and remain on track to complete the study in late 2013.”
“Millions of patients worldwide suffer from multiple sclerosis. If successful in this clinical study, NU100 offers these patients and their families the promise of another important treatment option for RRMS,” said Tracy Goeken, M.D., Vice President, Clinical and Medical Affairs. Nuron successfully completed recruitment of this 500-patient study in an impressive time of 1 year.
About the NU100 Phase 3 Trial
The Phase 3 clinical trial is designed to evaluate the safety and efficacy of NU100 in patients with RRMS as compared to placebo and an active comparator. The study has enrolled 500 patients from 110 clinical sites across Eastern and Western Europe. Patients have been randomized to receive NU100, Betaferon® or placebo and will be treated over a 12-month period. This unique pivotal trial was designed in collaboration with regulatory authorities as a one-year study to assess the primary endpoint of the study evaluating the cumulative number of new combined unique active lesions (CALs) on magnetic resonance imaging (MRI) scans at four months and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority to Betaferon. The secondary endpoints of the study will assess annualized relapse rates, proportion of relapse-free patients, incidence and severity of Flu-like symptoms and incidence of antibody formation against interferon beta-1b.
About Multiple Sclerosis
Multiple sclerosis (MS) is an autoimmune disease in which the body's own immune system, which normally serves to rid the body of foreign substances such as bacteria and viruses, mistakenly attacks a person's normal tissues. In MS, the immune system attacks the brain and spinal cord (the central nervous system). It is the most common progressive and disabling neurological condition in young adults. It has been estimated that MS affects approximately 2.5 million people worldwide and 400,000 people in the United States. RRMS accounts for 85 percent of initial diagnoses of MS. While there are various approved treatments for managing the symptoms of MS, there are currently no cures for the disease.
NU100 is a proprietary recombinant human interferon beta-1b produced utilizing proprietary manufacturing process technology. It is being developed as a standalone molecule for the treatment of relapsing remitting multiple sclerosis (RRMS) and as a new molecular entity based on positive opinion from the European Medicines Agency and the Food and Drug Administration. Patients treated with currently marketed interferon beta-1b products have up to 40 percent neutralizing antibody prevalence after two years of treatment. NU100 is essentially aggregate-free compared to those products; therefore, it should result in lower immune responses, potentially improving overall long-term clinical efficacy and improving the tolerability and safety for RRMS patients presently requiring therapy with interferon beta-1b.
About Nuron Biotech
Nuron Biotech is developing novel biologics and vaccines for the prevention and treatment of neurodegenerative and infectious diseases. Its team of industry veterans is committed to advancing products that meet unmet medical needs in the areas of multiple sclerosis, Alzheimer’s, Hepatitis B and Hepatitis C for patients across the globe. Nuron Biotech's lead drug candidate, NU100 (interferon beta-1b), is a new chemical entity currently in Phase 3 for patients with multiple sclerosis. www.nuronbiotech.com