Circassia Ltd, a specialty biopharmaceutical company focused on controlling immune system responses, announced today that it has initiated a phase II clinical study with its anti-allergy technology, ToleroMune. Circassia is conducting the study in the field of cat-dander allergy, and aims to complete the trial in the coming months.

This clinical study builds on the results of a previous double-blind, placebo-controlled phase II trial, which provided proof-of-concept for the ToleroMune technology. The current double-blind, placebo-controlled phase II trial will study both safety and surrogate efficacy outcomes, following escalating doses administered via two different routes (intradermal and subcutaneous). The study is taking place in Germany in up to 11 patient cohorts, with each containing 8 subjects with cat-dander allergy. Trial recruitment is progressing rapidly, and dosing is complete in the first patient cohort and ongoing in the second and third groups of patients.

"With clinical proof-of-concept already established for our ToleroMune technology, this phase II study will provide us with valuable data on both the most appropriate route of administration and dose optimization, which should be applicable across our entire anti-allergy product range," said Steve Harris, Circassia's CEO. "This study is particularly important for Circassia, moving our lead product closer to market, and at the same time establishing a development pathway for our other anti-allergy products."

Circassia's anti-allergy products have the potential to address significant market opportunities. Currently, over 150 million people suffer from allergic rhinitis in the US and Europe. The prevalence of cat-dander allergy is also high, with approximately 17% of Americans and 9% of Europeans suffering from the condition. Existing treatments have a number of issues, either providing symptomatic relief only or requiring lengthy specialist physician supervision over a period of many months due to potential serious, even life-threatening, adverse reactions. In contrast, Circassia's ToleroMune technology uses small sections of allergens (termed T-cell epitopes) to rapidly desensitize sufferers, while minimizing the potential for adverse reactions.

About Circassia

Circassia is a specialty biopharmaceutical company focused on developing medicines designed to control immune system responses. The company has a highly experienced management team with a proven track record in product development and commercialization, and having successfully completed two substantial fundraising rounds is backed by a syndicate of world-class venture capital and institutional investors, which includes Imperial Innovations, Lansdowne Partners, Goldman Sachs and Invesco Perpetual.

Circassia's lead products target allergies utilizing the company's proprietary T-cell epitope desensitization technology, ToleroMune, which was originally developed at Imperial College London. The company is also developing its ToleroTrans organ anti-rejection technology, which uses a similar approach to down-regulate immune responses in transplant patients. Circassia has a number of ongoing development programmes, with the most advanced against cat-dander allergy in phase II clinical testing.

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