OXFORD, England and SAN ANTONIO, February 25, 2013 /PRNewswire/ --
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."
About cat allergy
Allergies are a significant global health issue. Allergic rhinoconjunctivitis (ARC) affects up to 30% of adults and 40% of children in developed countries, and its prevalence is rising. ARC reduces quality of life and impacts school and work attendance and performance. In Continental Europe and the USA, cat allergy is one of the most common forms of the disease, and affects 10 - 15% of those with ARC and / or asthma. As cat dander is widespread in the human environment, and widely found in public buildings, patients with cat allergy may experience significant symptoms despite attempting to avoid exposure. Current treatment options include temporary symptom suppression with antihistamines, corticosteroids and cromones, or long-term whole allergen immunotherapy, which can require treatment for three to five years and has the potential to induce life-threatening anaphylactic reactions.
Circassia's cat allergy treatment is based on the company's novel, proprietary ToleroMune® technology. This uses rationally-designed combinations of synthetic peptides to generate regulatory T cells to control allergic responses and induce immune tolerance. Circassia's ToleroMune® cat allergy treatment consists of seven peptides identified from the major cat allergen Fel d 1. It has successfully completed a number of phase II studies, which demonstrate that courses of short, simple treatment can substantially reduce patients' symptoms and have a favourable safety profile. In long-term follow up, patients' symptoms remained greatly improved two years after the start of the study, despite no further treatment after the initial four doses given over 12 weeks. Circassia's cat allergy treatment entered phase III clinical testing in October 2012.
Circassia was founded by a team of highly experienced biotechnology scientists and entrepreneurs. The company is based in the UK on the Oxford Science Park, and its joint venture with McMaster University (Adiga Life Sciences Inc) is located in Hamilton, Canada. Circassia's ToleroMune® technology was developed originally by scientists at Imperial College, London. Having successfully completed five fundraising rounds, Circassia has raised approximately £105 million ($178 million) and is backed by a syndicate of world-class institutional investors, including Imperial Innovations and Invesco Perpetual.