Nuvo Europe and Immunology Group president Henrich Guntermann said that the company has been able to secure additional patent protection in the field of airway diseases for WF10 and its newly developed derivative formulations.
"Now that we have robust and clinically meaningful results from our Phase 2 WF10 allergic rhinitis clinical proof-of-concept trial conducted in Leipzig, Germany and supporting U.S. intellectual property protection, we will be further investigating the marketing opportunity and regulatory pathway to U.S. Food and Drug Administration (FDA) approval of WF10 in the U.S.," Guntermann added.
After receiving Germany’s BfArM authorization, in 2010, Nuvo initiated a Phase 2 clinical trial to evaluate WF10 infusions for treating the 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) and Total Ocular Symptom Score (TOSS).
Both the TNSS and TOSS are validated scales to measure the aggregation of nasal and ocular symptoms associated with allergic rhinitis.
The results were statistically significant as the p-values for the primary and secondary endpoints were less than 0.001 for the intent-to-treat and per protocol groups.