Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced the start of a pivotal phase 3 trial of its investigational ToleroMune® cat allergy treatment for cat allergen-induced rhinoconjunctivitis.
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 2 meeting with the US Food and Drug Administration, Scientific Advice from the European Medicines Agency and regulatory guidance from Health Canada, informing the path to registration in each territory.
The ToleroMune® cat allergy treatment phase 3 study follows positive results from a number of phase 2 trials. On September 17, the prestigious Journal of Allergy and Clinical Immunology published phase 2 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. "ToleroMune® cat allergy treatment represents a different therapeutic approach to existing therapies, with phase 2 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 3 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 3 study with our lead productis 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."