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Top-Line Results from Cat Allergy Phase III Study
Top-Line Results from Cat Allergy Phase III Study.
About this update from Niox Group Plc
[{"type":"text","content":"\n \nRNS Number : 6205B Circassia Pharmaceuticals Plc 20 June 2016 \n\nCircassia Announces Top-Line Results from Cat Allergy Phase III Study\nØ Primary endpoint not achieved\nØ Treatment groups had dramatically reduced Combined Score and symptoms\nØ Powerful placebo response eliminated ability to identify treatment effect\nØ Wider NIOX® and respiratory franchises unaffected by results\n \nOxford, UK - 20 June 2016: Circassia Pharmaceuticals plc (\"Circassia\" or \"the Company\"; LSE: CIR) today announces top-line results from its investigational cat allergy immunotherapy phase III study. In the study, both treatment regimens and placebo greatly, and equally, reduced subjects' combined allergy symptom and rescue medication use score from baseline. As a result of the very marked placebo effect the treatment did not meet the study's primary endpoint. The treatment was well tolerated with a highly favourable safety profile. \n \nSteve Harris, Circassia's Chief Executive, said: \"We are surprised and disappointed by these results. Such a dramatic placebo effect was not a feature of our earlier phase II studies. However, in this large-scale trial it eliminated the ability to identify a treatment effect despite dramatic improvements in subjects' allergy symptoms and rescue medication use. We will now rapidly analyse the full dataset, address the implications for our wider allergy pipeline and provide an update on the development plans for our broader business at our interim results. At the same time, we will continue to focus resolutely on our wider portfolio, rapidly growing the sales of our market-leading NIOX® asthma management products and advancing our pipeline of respiratory products.\"\n \nEfficacy\nThe study compared a four-dose course of Fel d 1 allergen peptides, two sequential courses (eight doses) and placebo. The primary endpoint measure was the mean Combined Score (combined total rhinoconjunctivitis symptom score [TRSS] and rescue medication use score); mean TRSS was a secondary endpoint measure. The study's endpoint outcomes were the difference between placebo and active groups one year after the start of dosing. \n· All groups had greatly improved Combined Score vs baseline\n(4 x 6nmol reduction = 58.2%; 8 x 6 nmol reducti...