Date: 2013-10-01
Type of information: Results
phase: 2
Announcement: results
Company: Circassia (UK)
Product: ToleroMune® grass allergy vaccine
Action mechanism:
Disease: grass allergy
Therapeutic area: Allergic diseases - Immune diseases
Country: Canada
Trial
details: During the randomised, double-blind, placebo-controlled phase II study conducted in 50 hay fever sufferers in Quebec, Canada, patients received four doses from one of five different treatment regimes over a 12-week period. Five weeks later, investigators tested the patients\' skin and eye responses to grass pollen.
The final phase of this phase II clinical trial was conducted in Kingston, Canada, and included 280 grass allergy sufferers who received one of three treatment regimens over three months, prior to the beginning of the pollen season. Those who received the optimal short course had significantly improved symptoms at the end of the season compared with those on placebo.
Latest
news: * On September 7, 2011, Circassia has announced positive phase II clinical results showing that its ToleroMune® hay fever vaccine substantially improved patients\' allergy symptoms compared with those on placebo. The treatment was extremely well tolerated. * On October 1, 2013, Circassia, a UK specialty biopharmaceutical company focused on allergy, has achieved successful results from a large phase II clinical study of its grass allergy treatment. Patients who received a short course of Circassia’s ToleroMune® grass allergy treatment before the pollen season had significantly improved allergy symptoms at the end of the season, compared with those on placebo. The treatment regimen was well tolerated, with a safety profile similar to placebo. Circassia plans to present the study results at a forthcoming leading scientific conference.
The results show that the treatment reduced allergic symptoms in patients' eyes by up to 30% more than placebo. In addition, the therapy improved early and late skin reactions by up to 54% and 19% above placebo respectively. The ToleroMune T-cell vaccine had a similar safety profile to placebo.
Following these results, Circassia has initiated the final phase II trial of its hay fever treatment. The double-blind, placebo-controlled study is underway in Kingston, Canada in 280 volunteers, and will assess the effectiveness of the ToleroMune T-cell vaccine at improving patients' nasal symptoms and eye responses when exposed to grass pollen in an exposure chamber.
