Positive phase II trial results from Circassia's ragweed allergy therapy

Circassia LtdMar 8 2012

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that its ragweed allergy therapy has achieved positive results in a key phase II clinical trial.  In the study, patients with more severe symptoms achieved a significantly greater improvement following treatment with the ToleroMune® T-cell vaccine than those on placebo (p≤0.05).  The results were presented at the 2012 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.  

"The results of this key phase II study are highly encouraging, because they show our ToleroMune ragweed allergy vaccine can reduce patients' symptoms after just a short course of treatment and, most importantly, offers the greatest improvement to those who can benefit most," said Steve Harris, Circassia's CEO. "We have now achieved successful phase II results with four of our allergy T-cell vaccines, which validate our scientific approach and give us the confidence to progress our lead programmes into the final phase of development."

Circassia's latest phase II study was designed to assess the T-cell vaccine's efficacy and tolerability and to identify the optimal treatment regime.  The trial was conducted in Canada in 275 ragweed allergy patients.  During the randomised, double-blind, placebo-controlled trial, volunteers received one of four regimens of ToleroMune treatment over a three-month period.  Patients were exposed to ragweed allergens in a validated exposure chamber, and investigators compared their nasal and ocular symptoms against the pre-treatment baseline.  The results show that the T-cell vaccine's optimal regimen substantially reduced patients' symptoms, achieving a 97% greater reduction than placebo (p≤0.05) in subjects who had a moderate level of symptoms at baseline.  The treatment was safe and well tolerated in all groups.