ToleroMune (Cat)

Circassia's allergy treatments are based on a new class of T-cell vaccines that utilize the Company’s proprietary ToleroMune® technology. This novel approach involves administering carefully selected sections of the molecules that cause allergic reactions (allergens) to shut down patients’ over sensitive immune responses, and thereby desensitize sufferers. These short molecular sections, called T-cell epitopes, provide rapid efficacy while minimizing potential adverse reactions for the patient. ToleroMune T-cell vaccines have successfully completed a number of clinical studies, and Circassia’s most advanced R&D program (its cat allergy treatment) is now entering final-stage development.

Circassia's ToleroMune cat allergy T-cell vaccine utilizes seven specific epitopes derived from cat dander. The vaccine has achieved phase II clinical validation, and clinical studies have identified the optimal dosing regimen for the final stage of clinical testing. The encouraging data from phase II clinical trials show that the ToleroMune T-cell vaccine can significantly reduce patients’ symptoms while proving extremely well tolerated. As a consequence Circassia is rapidly progressing its cat allergy program into late-stage development. The vaccine has also undergone phase II testing in patients with cat allergies and asthma as many sufferers have both conditions.

The randomized, double-blind, placebo-controlled, multi-center, international field study plans to enroll 1,182 patients aged 12 - 65 years old with cat allergen-induced rhinoconjunctivitis. The trial will include approximately 110 centers 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 standardized 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.