Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced the results of a phase II clinical study showing that a short course of just four doses of its ToleroMune® cat allergy therapy maintained improvements in patients' symptoms two years after the start of treatment. The results were presented at the 2013 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) in San Antonio, USA on Sunday 24 February.
The phase II study originally measured improvements in nasal and ocular allergy symptoms (Total Rhinoconjunctivitis Symptom Score; TRSS) in 202 patients, following treatment with ToleroMune® therapy or placebo. Two years after the start of the study, and having received no further ToleroMune® treatment, 50 of the original patients returned to reassess their symptoms while exposed to cat allergens. The results show that at the end of the cat allergen challenge, patients who had previously been treated with four doses of ToleroMune® therapy over 12 weeks had a significant improvement in symptoms two years later, compared with placebo (p<0.05; 50.0% TRSS improvement on ToleroMune® treatment vs 14.9% on placebo). These patients also maintained a substantial reduction in symptoms throughout their entire exposure to cat allergens over the four day challenge (38.3% TRSS improvement vs 13.4% on placebo). In addition, the results show that these patients maintained consistent symptom improvements both 12 and 24 months after the start of treatment. The ToleroMune® therapy was well tolerated with a safety profile comparable to placebo.
Commenting on the results, co-author of the AAAAI conference presentation, Professor Mark Larché , Canada Research Chair in Allergy and Immune Tolerance, McMaster University and St. Joseph's Healthcare, Hamilton, said, "Sustaining such a substantial improvement in patients' allergy symptoms two years after the start of the study is remarkable. Achieving this with a short course of just four doses is even more impressive. These results suggest that ToleroMune® therapy has the potential to revolutionise treatment for cat allergy patients."
"These excellent clinical results are extremely encouraging, and strongly support Circassia's decision to progress to phase III at the end of last year," said Steve Harris , Circassia's CEO. "Offering patients sustained symptom control without the need for ongoing treatment is an important objective for allergy therapy. In this study, our ToleroMune® treatment reduced symptoms by two and a half to three times the level achieved by several other allergy therapies in similar studies, and maintained the improvement over a significant period, demonstrating its potential to greatly improve the lives of patients around the world."