ToleroMune® Cat Allergy Treatment Clinical Results – Rapid Four-Dose Regimen Maintains Significant Symptom Reduction One Year After Starting
Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced the publication of positive phase II results with its ToleroMune(R) cat allergy treatment in the Journal of Allergy and Clinical Immunology (JACI). The results show that cat allergy patients who received four doses of ToleroMune(R) treatment over 12 weeks maintained a significantly greater improvement in symptoms one year after the start of the study compared with placebo (p=0.0104).
“These results are extremely encouraging, as they suggest our novel ToleroMune(R) cat allergy therapy has the potential to modify the underlying allergic disease, and thereby offer patients ongoing symptom improvement after just a short course of treatment,” said Steve Harris, Circassia’s CEO. “The peer-reviewed publication of these clinical results in the leading journal in the allergy field, the Journal of Allergy and Clinical Immunology, is an important achievement for Circassia as we rapidly progress our ToleroMune(R) treatment into phase III development.”
The study, ‘Fel d 1-derived peptide antigen desensitization shows a persistent treatment effect 1 year after the start of dosing: A randomized, placebo-controlled study,’ was published online on 17 September*, and will appear in an upcoming edition of JACI. The trial included 202 patients with cat allergy who received placebo or Circassia’s ToleroMune(R) treatment, which consists of seven synthetic peptides derived from the major cat allergen Fel d 1. One year after the start of the study, 89 patients returned to reassess their symptoms while exposed to cat allergens. The study found an immediate and continuing improvement in patients’ symptoms following four doses of the ToleroMune(R) treatment over 12 weeks, and a significant decrease compared with placebo one year after the start of the trial despite no further dosing. The authors note that the symptom reduction represents a substantial improvement over a number of allergy treatment approaches investigated previously. The ToleroMune(R) treatment was well tolerated and had a safety profile similar to placebo.
* Patel D et al. Fel d 1-derived peptide antigen desensitization shows a persistent treatment effect 1 year after the start of dosing: A randomized, placebo-controlled study. J Allergy Clin Immunol 2012 online 17 September:
A summary of the study is published on the American Academy of Allergy Asthma and Immunology website
About Circassia’s ToleroMune(R) allergy treatments
Circassia is developing a range of allergy treatments based on its proprietary ToleroMune(R) technology. This uses small sections of allergens (epitopes) to generate regulatory T cells that suppress allergic responses and create immune tolerance in patients. The company has successfully completed a number of phase II studies with its cat, house dust mite, ragweed and grass allergy therapies. Clinical results show that short courses of Circassia’s allergy treatments can greatly reduce patients’ allergic responses, without the need for adjuvants or other immune stimulators, while proving extremely well tolerated. As a result, the treatments offer major potential clinical benefits compared with existing therapies, and have significant market opportunities. More than 150 million people suffer from allergic rhinitis in the US and Europe, and the current treatment market is valued at approximately $12 billion per year.
Circassia was founded in 2006 by a team of highly experienced biotechnology scientists and entrepreneurs, and is chaired by the former Chairman of GlaxoSmithKline, Sir Richard Sykes. 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(R) technology was developed originally by scientists at Imperial College, London. Having successfully completed five fundraising rounds, Circassia has raised approximately GBP105 million ($178 million) and is backed by a syndicate of world-class institutional investors, including Imperial Innovations and Invesco Perpetual.