Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced it has received Health Canada approval to conduct a new Phase 2 clinical trial (the 2015 WF10 Trial) to assess WF10 for the treatment of allergic rhinitis.
The 2015 WF10 Trial will commence this month. It 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 and will build on learnings derived from previous WF10 allergic rhinitis studies run in 2010 and 2014 (the 2010 WF10 Trial and 2014 WF10 Trial, respectively). Patients' symptoms have already been recorded prior to commencement of the 2015 WF10 Trial in an Environmental Exposure Chamber (EEC), and will be recorded in the field during 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.
"We are excited to get this critical trial underway," said Dr. Henrich Guntermann, President, Europe & Immunology Group. "The design of the new study includes a number of features that differentiate it from our inconclusive 2014 WF10 Trial to enhance the chance of a successful outcome including (i) enrollment of larger numbers of patients per arm (ii) the use of an EEC to fully-characterize patients prior to entry into the study, (iii) a tight enrollment window to ensure consistent patient exposure to allergens and (iv) the use of electronic diaries to capture daily symptom scores. We are optimistic that by the end of this year or early 2016, we will have positive trial results that will support the further development of WF10."
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.