Today, Circassia Ltd, announced that results from their phase II trial of their ToleroMune(R) hay fever vaccine have shown that the treatment has significantly improved participants' allergy signs and symptoms in comparison to those on placebo. The company added that the vaccine was well tolerated.
The randomized, double-blind, placebo-controlled phase II investigation enrolled 50 individuals in Quebec, Canada, who suffer from hay fever. During the study participants received four doses from one of five different treatment regimens over a period of 12 weeks.
After 5 weeks, the researchers tested participants' skin and eye responses to grass pollen. The results revealed that the ToleroMune vaccine reduced allergic symptoms in participants' eyes by up to 30% more than those taking placebo. Furthermore, the treatment improved early skin reactions by up to 54% and late skin reactions by up to 19% more than those on placebo. The ToleroMune T-cell vaccine had a equivalent safety profile to placebo.
The final phase II trial of Circassia's hay fever vaccine, consisting of 280 participants is currently underway in Kingston, Canada. The trial will evaluate the efficacy of the ToleroMune T-cell vaccine at enhancing individuals' nasal symptoms and eye responses when grass pollen is added to an exposure chamber.
Steve Harris, Circassia's CEO, explained:
"Achieving these clinical results is particularly encouraging as hay fever is an extremely common allergy, which can have a major impact on sufferers. Many current therapies provide short-term symptom relief only, while traditional immunotherapies can require specialist treatment over several years to address the underlying disease. Circassia's latest results follow earlier successful studies in a range of different allergies. Our clinical data show that Circassia's T-cell vaccines have the potential to revolutionize allergy therapy, and these recent results give us the confidence to proceed with the final phase II testing of our unique hay fever treatment."
About Circassia's allergy T-cell vaccines
Circassia is currently developing a range of allergy T-cell vaccines based on its proprietary ToleroMune(R) technology. So far they have successfully completed numerous phase II investigations with their ragweed, house dust mite, cat, and grass allergy treatments.
Results have demonstrated that treatment with its T-cell vaccines significantly diminish allergic responses in humans, without the need for other medications or immune stimulators. They also appear to be very well tolerated, the company adds.
Circassia believes its treatments, compared to what is already on the market, offer enormous clinical benefits.
In the U.S. and Europe more than 150 million individuals suffer from allergic rhinitis, and roughly 15% - 25% of individuals in these countries are sensitive to grass pollen. Circassia informs that the current allergy treatment market is worth around $12 billion each year.
Written by Grace Rattue