Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced additional details of its new Phase 2 clinical trial (the 2015 WF10 Trial) to assess WF10 for the treatment of allergic rhinitis.
The 2015 WF10 Trial will be a randomized, double-blind, placebo-controlled, single-center trial to assess the efficacy, safety and tolerability of a regimen of five WF10 infusions. The trial will enroll patients who have a moderate to severe allergy to grass and ragweed pollen. Patients' symptoms will be recorded prior to commencement of the grass allergy season in an Environmental Exposure Chamber (EEC), in the field throughout the grass and ragweed allergy seasons and again in the EEC after completion of the ragweed season. The 2015 WF10 Trial is expected to enroll approximately 146 patients and to be completed with topline results available in late Q4 2015 or early Q1 2016. The trial will be conducted in southern Ontario, Canada by Inflamax Research Inc. (Inflamax), a full service, specialty Contract Research Organization (CRO) that specializes in allergy, respiratory and EEC studies. Nuvo's external costs of conducting the trial will be approximately CDN$5.0 million. Commencement of the 2015 WF10 Trial is subject to regulatory approval by Health Canada.
If the 2015 WF10 Trial is successful, the Company plans to continue WF10 development in an independently financed entity that will include the participation of Nuvo shareholders. While Nuvo's management is optimistic that the 2015 WF10 Trial will generate positive results, should the trial be unsuccessful, the Company plans to discontinue WF10 development. The Company has taken steps to curtail spending on a number of WF10 projects and studies planned for 2015 until results of the 2015 WF10 Trial are available.
"This is a critical trial to the future of WF10," said Dr. Henrich Guntermann, President, Europe & Immunology Group. "It is designed to increase the likelihood that patients are exposed to sufficient concentrations of allergens to which they are allergic. We believe that a lack of allergen exposure led to inconclusive results in our 2014 Phase 2 clinical trial and we expect that the results of this new trial will more closely compare to the positive results from our 2010 clinical trial."
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