Circassia Begins Phase II Clinical Trial With Ragweed Allergy Therapy

Main Category: Allergy
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 14 May 2009 - 1:00 PDT

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Circassia Ltd, a specialty biopharmaceutical company focused on allergy, announced that it has initiated a phase II clinical development programme for its ragweed allergy therapy. The treatment for allergic rhino-conjunctivitis caused by ragweed pollen is based on Circassia's ToleroMune(R) technology, which has previously achieved successful phase II results in patients with cat allergies. Ragweed is one of the leading causes of allergic reactions in North America, where allergies to its pollen are commonly referred to as 'hay fever'.

Circassia is undertaking its latest phase II clinical study in Canada. The double-blind, randomised trial will include 50 patients with confirmed ragweed allergies, and will compare a range of ToleroMune doses with placebo. Unlike most current immunotherapies, which require careful dose escalation over many months and several years of maintenance doses, patients will receive just four standardized doses of ToleroMune treatment over a number of weeks. During the trial investigators will 'challenge' the volunteers with ragweed pollen to assess the impact of the therapy.

"Broadening the range of allergies targeted by ToleroMune is an important step for Circassia, underlining our confidence in this breakthrough technology. We have already achieved encouraging results in patients with cat allergies, and are excited to be extending our portfolio of therapies to encompass ragweed allergy," said Steve Harris, Circassia's CEO. "Allergies to ragweed pollen are very common in the US, where they affect over a quarter of the population, and are a growing problem in Europe. We believe that Circassia's new therapy should offer patients important benefits, as ToleroMune has the potential to address the underlying cause of allergy using short, simple courses of treatment that minimize the risk of severe and sometimes life-threatening side effects associated with many existing treatments."

About Circassia

Circassia is a specialty biopharmaceutical company focused on the field of allergy. The company's range of allergy therapeutics utilizes its proprietary T-cell epitope desensitization technology, ToleroMune. Circassia's products offer potential major clinical benefits compared with existing 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 supply benefits for Circassia. Its state-of-the-art manufacturing fits with changes in the European regulatory environment, where authorities are increasingly treating allergen immunotherapies as pharmaceutical products, and eliminating the batch-to-batch potency variability that is an intrinsic feature of many currrent treatments.

Circassia has a highly experienced management team with a proven track record in product development and commercialization. Having successfully completed two fundraising rounds the company is backed by a syndicate of world-class venture capital and institutional investors, including Imperial Innovations, Lansdowne Partners, Goldman Sachs and Invesco Perpetual.

Source: Circassia Ltd