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Circassia conducted the double-blind study in Canada, where 121 subjectswith confirmed cat allergies were randomised to receive placebo or one offour different treatment regimes with standardised doses of ToleroMune. Thevolunteers were exposed to cat allergens (aerosolised dander) in anenvironmental exposure chamber for 3 hours each day on four consecutive days,both before and after treatment. At set time points the subjects scored theirocular and nasal symptoms to allow investigators to measure the effect of theToleroMune treatment. This is the first trial of a cat allergy immunotherapyto use this validated approach.
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The study's results demonstrate that ToleroMune therapy can dramaticallyreduce both nasal and ocular allergy symptom levels, and that the treatmenteffect grows as the duration of exposure increases and symptoms are at theirgreatest. The optimal regimen decreased total symptom scores by 67% comparedwith placebo. Throughout the study ToleroMune treatment was extremely welltolerated, with a safety profile similar to placebo. This contrasts with manytraditional immunotherapies, which are associated with a range of localtolerability issues and sometimes severe and even life-threatening adverseevents.
"These positive phase II results are extremely important for Circassia asthey identify the optimal treatment regime to move into the final stages ofdevelopment for our cat allergy therapy, and will prove invaluable as weprogress our broader portfolio of ToleroMune products," said Steve Harris,Circassia's CEO. "We are particularly pleased that the ToleroMune treatmentachieved such a marked improvement in ocular symptoms, which can be aparticular problem in cat allergy. As well as benefiting patients, thiseffect scientifically validates the ToleroMune approach and its novel focuson generating regulatory T cells to shut down this type of IgE-mediatedallergic response."
About Circassia
Circassia is a specialty biopharmaceutical company focused on the fieldof allergy. The company's range of allergy therapeutics utilises itsproprietary T-cell epitope desensitisation technology, ToleroMune, in a shorttreatment regime without the need for adjuvants or other immune stimulators.Circassia's products offer potential major clinical benefits compared withexisting therapies, and consequently have significant market opportunities.Over 150 million people suffer from allergic rhinitis in the US and Europe,and the current treatment market is approximately $12 billion per year.
ToleroMune technology has additional potential regulatory and supplychain benefits. The short peptides utilised in Circassia's products aremanufactured chemically, in contrast to existing allergen immunotherapies,which are purified from natural sources. Circassia's approach applies thechemistry, manufacturing and control standards associated with conventionalpharmaceuticals to immunotherapy. This fits with changes in the Europeanregulatory environment, where authorities are increasingly treating allergenimmunotherapies as pharmaceutical products, and requiring elimination of thebatch-to-batch potency variability that is an intrinsic feature of manycurrrent treatments.
Circassia has a highly experienced management team with a proven trackrecord in product development and commercialisation. Having successfullycompleted two fundraising rounds the company is backed by a syndicate ofworld-class venture capital and institutional investors, including ImperialInnovations, Lansdowne Partners, Goldman Sachs and Invesco Perpetual.For more information please visit http://www.circassia.co.uk. Contacts Steve Harris CEO Circassia Tel: +44-(0)1865-784574 Rob Budge RJB Communications Tel: +44-(0)1865-760969 Mobile: +44-(0)7710-741241
SOURCE Circassia Ltd
