Circassia reports positive results from phase II clinical study of ToleroMune grass allergy treatment

Circassia Ltd, a specialty biopharmaceutical company focused on developing world-class immunotherapies, today announced successful results from a large phase II clinical study of its ToleroMune® grass allergy treatment (Grass-Synthetic Peptide Immuno-Regulatory Epitope [Grass-SPIRE]). Patients who received a short course of treatment before the pollen season had significantly improved allergy symptoms at the end of the season, compared with those on placebo. The Grass-SPIRE treatment was extremely well tolerated.

“We are delighted with the excellent outcome in this clinical study, as this is now the fourth of our short-course SPIRE allergy treatments to achieve a statistically significant result in large phase IIb studies,” said Steve Harris, Circassia’s Chief Executive. “In many countries, including the US and Europe, grass pollen is the most common cause of seasonal allergy. As a result, grass allergy is a major problem causing suffering for many millions of people each year and significant lost productivity. By dramatically improving patients’ symptoms after just a short course, our grass allergy therapy has the potential to transform the treatment of this highly prevalent immune disorder and improve sufferers’ quality of life.”

The double-blind, placebo-controlled, randomized study included 280 grass allergy sufferers. During the trial, which was conducted in Kingston, Canada, subjects recorded their allergy symptoms while exposed to grass pollen in a controlled environmental unit, both before treatment and at the end of the hay fever season. Study participants received one of three treatment regimens over three months, which were completed prior to the beginning of the pollen season. Those who received the optimal short course of SPIRE therapy had significantly improved symptoms at the end of the season compared with those on placebo (p<0.05). The treatment regimen was well tolerated, with a safety profile similar to placebo. Circassia plans to present the study results at a forthcoming leading scientific conference.

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