Circassia Ltd, a specialty biopharmaceutical company focused on allergy, has started a pivotal phase III trial of its investigational ToleroMune cat allergy treatment for cat allergen-induced rhino conjunctivitis. The multinational study in almost 1,200 subjects incorporates input from leading medical experts from Europe and North America, and follows a constructive End of phase II meeting with the US FDA, Scientific Advice from the European Medicines Agency (EMA) and regulatory guidance from Health Canada, informing the path to registration in each territory.
The ToleroMune cat allergy treatment phase III study follows positive results from a number of phase II trials. On September 17, the prestigious Journal of Allergy and Clinical Immunology published phase II data showing patients had a significantly greater reduction in symptoms compared with placebo one year after the start of the study, despite receiving only a four-dose course of treatment over 12 weeks.
"Allergy to cat dander is a common condition, and can greatly reduce patients' quality of life, impact work or school performance and exacerbate asthma symptoms," said the study's Principal Investigator, Professor Harold S Nelson MD of National Jewish Health, Denver, Colorado. Prof Nelson added, "ToleroMune cat allergy treatment represents a different therapeutic approach to existing therapies, with phase II data suggesting it is the most exciting innovation in the field of allergy for decades. Maintaining sustained allergen tolerance over an extended period without requiring ongoing dosing would represent a major step forward, and this large ToleroMune cat allergy treatment phase III study aims to confirm definitively if this can be achieved."
"Circassia's goal is to revolutionise the treatment of allergy, and the start of this phase III study with our lead product is a major strategic milestone in this endeavour", said Steve Harris, Circassia's CEO. "Tens of millions of people are allergic to cats in the United States and Europe, and the disease can have a major effect on patients' quality of life. For many years sufferers have had limited treatment options, and currently no short, simple treatment with long-lasting impact on the disease is available. We believe our ToleroMune technology has the potential to address this unmet medical need, and our initiation of the final phase of clinical development demonstrates our commitment to helping improve patients' lives."
The randomised, double-blind, placebo-controlled, multi-centre, international field study plans to enrol 1,182 patients aged 12 - 65 years old with cat allergen-induced rhinoconjunctivitis. The trial will include approximately 110 centres located in the United States, Canada and five countries in Europe. The study will evaluate the safety and efficacy of both a single course and two courses of investigational ToleroMune cat allergy treatment, with each course consisting of four standardised doses administered over 12 weeks.
The trial's primary efficacy endpoint will be the combined reduction in rhinoconjunctivitis symptoms and rescue medication use one year after the start of treatment, compared with placebo. The study is expected to complete in Summer 2014.