Date: 2014-06-13
Type of information: Results
phase: 2b
Announcement: results
Company: Circassia (UK)
Product: HDM-SPIRE (house dust mite allergy product candidate)
Action mechanism:
Disease: house dust mite allergy
Therapeutic area: Allergic diseases - Immunological diseases
Country: Canada
Trial
details: The double-blind, randomised phase IIb trial (TH002) was conducted in Toronto, Canada, where 172 volunteers with confirmed house dust mite allergy received one of four treatment regimens or placebo. Investigators measured patients’ allergy symptoms when exposed to house dust mite allergens at baseline and during the 12-month study. Those who received a short course of four 12-nmol doses over 12 weeks had a significant improvement in their symptoms one year after starting the treatment compared with those on placebo (p=0.02). All treatment regimens were well tolerated, with a safety profile similar to placebo. The 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.
Latest
news: * On June 13, 2014, Circassia Pharmaceuticals, a clinical-stage specialty biopharmaceutical company, 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.
The 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.
Highlights from phase IIb two-year follow-up study
• 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;
• 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;
• 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;
• HDM-SPIRE continues to be well-tolerated with no late-onset safety concerns identified.
Building on the encouraging data generated from the HDM-SPIRE clinical programme to date, Circassia plans to initiate a randomised, double-blind, placebo-controlled phase IIb field study (TH005) to: confirm the efficacy of a short course of four 12-nmol doses seen in the first phase IIb study; evaluate two courses of HDM-SPIRE (eight doses); and evaluate the safety and efficacy of a higher 20-nmol dose of HDM-SPIRE. Having agreed the design with the FDA in May 2014, this study is on track to start in Q4 2014. A phase II controlled asthmatic safety study (TH004) in 30 subjects is also due to report in H2 2014.
