Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced the results of its 16-week, double-blind, placebo-controlled, Phase 2 clinical trial conducted in Germany to compare the safety and efficacy of WF10 and its main constituents (sodium chlorite and sodium chlorate) with saline in patients with refractory allergic rhinitis and to compare the safety and efficacy of WF10 and its main constituents. The study included three active arms (the Active Arms): a) WF10; b) WF10 with chlorate and sulphate removed; and c) WF10 with chlorite and sulphate removed. Each of the Active Arms was compared to a placebo arm in which patients received saline. Active or placebo treatments were administered by five intravenous infusions given once per day during the first five days of the study. The primary endpoint was change in Total Nasal Symptom Score (TNSS) from baseline to assessment after three weeks. TNSS is a validated scale to measure nasal symptoms associated with allergic rhinitis.
Topline Findings of the Study are:
- The WF10 arm demonstrated a reduction in TNSS over the course of the observation period, similar to the reduction in TNSS demonstrated in the WF10 arm in the Company's previous 2010 Phase 2 proof-of-concept study described further below.
- The placebo arm demonstrated a reduction in TNSS over the course of the observation period that was significantly greater than demonstrated in the placebo arm of the Company's 2010 Phase 2 proof-of-concept study.
- Each of the Active Arms demonstrated a greater reduction in TNSS than placebo; however, (i) the difference between the WF10 arm and the placebo arm did not achieve statistical significance 3 weeks after commencement of the study which was the study's primary endpoint and (ii) the difference between the Active Arms and the placebo arm did not achieve statistical significance at measured time points over the course of the observation period.
- Treatments administered in the Active Arms were well tolerated with favourable safety profiles.
The Company is conducting a detailed review of the data and expects to release further information and analysis of the data including information on secondary endpoints in the coming weeks.
"While the WF10 arm performed as expected, the placebo arm demonstrated a much greater than anticipated reduction in allergy symptom scores," said Dr. Henrich Guntermann, President, Europe & Immunology Group. "The cold and wet allergy season in Germany may have reduced symptoms for all patients in the study and possibly impacted the difference in symptoms between the WF10 arm and the placebo arm. We are conducting a more detailed analysis of the data which we will report when it becomes available."