Research - WF10
The Company currently conducts the majority of its WF10 research in Nuvo Research
AG located in Leipzig, Germany. In 2009, Nuvo Research AG initiated a co-operative drug development program with the Fraunhofer Institute for the clinical and preclinical development of WF10 as a potential treatment of two autoimmune related indications – allergic rhinitis and rheumatoid arthritis. The Development Bank of Saxony has committed to provide financial support for both of these projects over a three-year period. This provides Nuvo with a “lower risk” approach to moving development of WF10 forward on an expedited basis.
In 2010, after receiving BfarM approval, the Company conducted a Phase 2 clinical trial to evaluate WF10 as a treatment for moderate to severe allergic rhinitis. The trial was a 60-subject randomized, double blind, placebo-controlled, single-centre trial to assess the efficacy and safety of a regimen of five WF10 infusions on consecutive days at the beginning of the trial for the treatment of patients with moderate to severe persistent allergic rhinitis. The trial met its primary endpoint as measured by the change in Total Nasal Symptom Score (TNSS) from baseline to assessment after three weeks comparing the WF10 group with the placebo group. The TNSS is a validated scale to measure the aggregation of nasal symptoms associated with allergic rhinitis. The p-value for the primary endpoint was less than 0.001 for the intent-to-treat and per protocol groups. The Company is continuing to evaluate the entire data set including the secondary endpoints. Once the analysis is complete, the Company in consultation with key opinion leaders specializing in immunology, airway diseases and rheumatoid arthritis will formalize the future development plan for WF10 in order to maximize its value to the Company.