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Circassia Announces Results from Phase IIb Study
Circassia Announces Results from Phase IIb Study.
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[{"type":"text","content":"\n \nRNS Number : 5237J Circassia Pharmaceuticals Plc 13 June 2014 \n \n\n-- Circassia Announces Results from House Dust Mite Allergy Treatment Phase IIb Two-Year Follow-up Study --\n \nOxford, UK - 13 June 2014:Circassia Pharmaceuticals plc (\"Circassia\" or \"the Company\") (LSE: CIR), a clinical-stage specialty biopharmaceutical company, today announces positive top-line results from a two-year follow-up of a phase IIb clinical study of HDM-SPIRE, a house dust mite allergy product candidate based on Circassia's proprietary ToleroMune® platform technology. \n \nThe phase IIb two-year follow-up study (TH002A) enrolled 72 subjects who had previously received either placebo or one of two 12-nmol dose regimens as part of the original phase IIb study (TH002) which randomised 172 subjects. One year on from the last assessment point, and two years after starting treatment with HDM-SPIRE or placebo, investigators reassessed patients' allergy symptoms when exposed to house dust mite allergen in an environmental exposure chamber. Improvements in nasal and ocular symptoms were measured using the Total Rhinoconjunctivitis Symptom Score (TRSS) on the second and third days of the three-day house dust mite allergen challenge. \n \nHighlights from phase IIb two-year follow-up study \n· Improvements in TRSS compared to placebo in the 4 x 12-nmol treatment group1 observed at two years were equivalent to the reductions in the same group of subjects observed at one year; \n· As seen in previous SPIRE clinical studies, subjects with more severe allergy symptoms demonstrated a greater treatment effect after receiving HDM-SPIRE compared to placebo;\n· When data from all three days of the house dust mite allergen challenge were included, improvements in TRSS compared to placebo in the 4 x 12-nmol treatment group1 were even greater when compared to the second and third days alone;\n· HDM-SPIRE continues to be well-tolerated with no late-onset safety concerns identified; and\n· These encouraging data will be used to inform the wider HDM-SPIRE clinical programme.\n \n1. Subjects in this treatment group received a short course of four...