Nuvo Research Inc. has announced that the United States Patent Office has granted U.S. Patent No. 8,435,568, relating to compositions and methods of using WF10 and new derivative formulations for the treatment of allergic asthma, allergic rhinitis and atopic dermatitis.
"We are pleased that we have been able to secure additional patent protection in the field of airway diseases for WF10 and its newly developed derivative formulations," said Dr. Henrich Guntermann, Nuvo's President, Europe and Immunology Group.
Dr. Guntermann continued, "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."
In early 2010, after receiving Germany's BfArM authorization, the Company initiated 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 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 trial also met its secondary endpoints as measured by the change in TNSS at six, nine and twelve weeks and in the Total Ocular Symptom Score (TOSS) from baseline to assessment after three, six, nine and twelve weeks.
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. No drug-related adverse events were reported by trial participants.