NU100 (Interferon Beta-1b)
NU100 is a proprietary recombinant human interferon beta (formerly BaroFeron) being developed for the treatment of Multiple Sclerosis. It is developed as a new molecular entity (NME). Nuron initiated the Phase 3 clinical studies in Oct. 2011.
NU100, a proprietary recombinant human interferon beta-1b produced utilizing PreEMT™ technology, is being developed as a standalone molecule for the treatment of patients with Relapsing Remitting Multiple Sclerosis, (RRMS). Interferon beta products are considered the ‘gold’ standard for first line treatment options in the management of Multiple Sclerosis. However, clinical evidence and physician surveys indicate a need to improve upon the efficacy and safety of currently available therapies. MS patients treated with currently marketed Interferon beta-1b products have a prevalence of up to 30-40% neutralizing antibodies after two years of treatment. NU100 is a liquid product with an autoinjector and essentially aggregate free compared to other marketed interferon beta products. Therefore, absence of aggregates in NU100 should result in lower immune response in patients compared to other marketed products. By reducing or eliminating immune responses to interferon beta, NU100 should prevent the reduction in clinical efficacy and improve the tolerability and safety for RRMS patients who presently require therapy with interferon beta-1b.
The 2010 annual market size for RRMS products (Interferon beta / glatiramer acetate) was $12.7 billion globally.
NU400 (Long Acting Interferon Beta-1b)
NU400 is a long-acting version of Nuron’s proprietary recombinant human interferon beta-1b (NU100) produced using a combination of NU100 and proprietary TheraPEG™ technology. PEGylating NU100 can increase NU100′s circulating half-life and potentially improve other pharmaceutical properties including its solubility, stability and safety profile. NU400 should carry the benefit of NU100 with reduced injection frequency, potentially semi-monthly or monthly injection for better patient compliance. Nuron intends to initiate early phase clinical studies in 2012.