OXFORD, England, September 12, 2013 /PRNewswire/ --
Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced successful results from a phase II clinical study of its house dust mite allergy treatment (House Dust Mite-Synthetic Peptide Immuno-Regulatory Epitope [HDM-SPIRE] based on Circassia's ToleroMune® technology). Patients who received four doses of the treatment over 12 weeks had significantly improved allergy symptoms one year after the start of the trial compared with placebo, meeting the study's long-term primary endpoint. The HDM-SPIRE treatment was extremely well tolerated.
"These results in house dust mite allergy are particularly exciting as they reflect the significant long-term improvements we achieved with a similar short course of our Cat-SPIRE allergy treatment," said Steve Harris, Circassia's Chief Executive. "In the US, Europe and many other countries house dust mites are responsible for more allergies than any other allergen, causing year-round suffering for millions of people. Reducing patients' symptoms over the long-term is an important goal, and these results demonstrate the potential of our ToleroMune® technology to revolutionise allergy therapy by achieving this with a simple short course of treatment."
The double-blind, randomized trial was conducted in Toronto, Canada, where 172 volunteers with confirmed house dust mite allergy received one of four treatment regimens or placebo. Investigators measured patients' allergy symptoms when exposed to house dust mite allergens, at baseline and during the 12-month study. Those who received a short course of four doses over 12 weeks had a significant improvement in their symptoms one year after starting the treatment compared with those on placebo (p=0.02). All treatment regimens were well tolerated, with a safety profile similar to placebo. Circassia has submitted the study results for presentation at a leading scientific conference.
About house dust mite allergy
House dust mites are found widely throughout homes, in bedding, carpets, soft furnishings and clothing. Allergy to proteins in the mites' droppings is extremely common, and often associated with asthma. In the United States and Europe, approximately one-in-four people are sensitised to house dust mites, with more people having allergic responses than to any other common allergen. House dust mite allergy is a perennial condition that can impact sufferers' education, work, quality of life and social activities.
About ToleroMune® technology
Circassia is developing a range of allergy treatments based on its novel, proprietary ToleroMune® technology. This uses rationally-designed molecules identified from common allergens (Synthetic Peptide Immuno-Regulatory Epitopes; SPIREs) to generate regulatory T cells to control allergic responses and induce immune tolerance. Circassia has successfully completed a number of phase II studies with its house dust mite, ragweed and grass allergy therapies, and its cat allergy treatment entered phase III testing in October 2012.
Clinical results show that short, simple courses of SPIRE allergy treatments can greatly reduce patients' allergic responses and improve symptoms over long periods, while proving extremely well tolerated. As a result, SPIRE 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 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.
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