Nuvo Research Announces Positive Top-Line WF10 Phase II Trial Results
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Nuvo Research Inc., a specialty pharmaceutical company focused on the research and development of drug products that are delivered into and through the skin using its topical and transdermal drug delivery technologies and on the development of its immune modulating drug candidate WF10, has announced that its European Phase II clinical trial evaluating WF10 as a treatment for severe allergic rhinitis met its primary endpoint.
"These top-line results support our view that WF10 has the potential to become an effective treatment for patients with certain autoimmune conditions, such as severe allergic rhinitis," said Henrich Guntermann, President, Europe & Immunology Group for Nuvo Research. "We will evaluate the entire data set when it is available and consult with our advisors to determine the optimal path forward to maximize the value of WF10 for Nuvo and its shareholders."
The randomized, double-blind, placebo-controlled, single-centre trial assessed the efficacy and safety of WF10 infusions for the treatment of patients with severe persistent allergic rhinitis. The trial enrolled 60 patients who have at least a two-year history of persistent allergic rhinitis and who had a positive allergen skin test.
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.
No significant adverse events were observed during the trial, which was conducted at a clinic site that specializes in airway diseases in Leipzig, Germany.
"These top-line results support our view that WF10 has the potential to become an effective treatment for patients with certain autoimmune conditions, such as severe allergic rhinitis," said Henrich Guntermann, President, Europe & Immunology Group for Nuvo Research. "We will evaluate the entire data set when it is available and consult with our advisors to determine the optimal path forward to maximize the value of WF10 for Nuvo and its shareholders."
The randomized, double-blind, placebo-controlled, single-centre trial assessed the efficacy and safety of WF10 infusions for the treatment of patients with severe persistent allergic rhinitis. The trial enrolled 60 patients who have at least a two-year history of persistent allergic rhinitis and who had a positive allergen skin test.
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.
No significant adverse events were observed during the trial, which was conducted at a clinic site that specializes in airway diseases in Leipzig, Germany.
