Nuvo Research Inc. (TSX:NRI), a life sciences company with growing revenues and a diverse portfolio of topical products, today announced the results of its investigational Phase 2 clinical trial of WF10 (Trial) for the treatment of allergic rhinitis.
Study Results and Company Strategy
Patients dosed with WF10 did not report a reduction in symptoms that was significantly better than patients dosed with a saline placebo at any of the endpoints being measured in the study. There was no significant difference in the performance of WF10 relative to placebo when patients were exposed to grass and ragweed pollen in the Environmental Exposure Chamber (EEC) or when they were exposed to naturally occurring allergens during the field portion of the study.
The Company believes that the results are not sufficient to justify the further development of WF10 for the treatment of allergic rhinitis and plans to discontinue all WF10 development. The Company has a strong balance sheet and these results do not affect the Company's previously announced plans to split Nuvo into two separate, publicly traded companies. Under the proposed plan, one company, to be known as Nuvo Pharmaceuticals Inc. (Nuvo Pharma), will be a commercial healthcare company that will own the Company's Pennsaid and Pennsaid 2% franchises and related assets, and is expected to generate revenue, positive EBITDA and positive net earnings. The other company, to be known as Crescita Therapeutics Inc. (Crescita), will be a drug development company that will own the Company's existing drug development business, including the topical product candidates Flexicaine for the treatment of diabetic peripheral neuropathy, IBUFOAM for the treatment of acute and chronic pain and Onychomycosis Solution for the treatment of onychomycosis, all of which target sizeable market opportunities. Nuvo's shareholders will own 100% of both companies at the time of the split.
"The results of this study make it clear that we should focus our R&D resources on advancing our very promising topical product candidates rather than WF10," said Dan Chicoine, Nuvo's Chairman and Co-CEO. "We have developed specific strategies and are refining development timelines for the advancement of each of these product candidate and plan to finalize and outline the details in Q1 2016."