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| |  Allergen-Free Immunotherapy Relieves Dust Mite Rhinoconjunctivitis: Presented at EAACI By Sara Freeman LONDON -- June 10, 2010 -- A novel, allergen-independent immunomodulator (CYT003-QbG10) reduces the symptoms of rhinoconjunctivitis caused by an allergy to house dust mites, according to a phase 2b study presented here at the 29th Congress of the European Academy of Allergy and Clinical Immunology (EAACI). Six weekly, 1-mg doses of the novel agent improved both objective and subjective rhinoconjunctivitis-related study endpoints compared with placebo, said Ludger Klimek, MD, Center of Rhinology and Allergology Wiesbaden, Wiesbaden, Germany, on June 6. "This new treatment modality opens the door for addressing multiple allergies and severe allergies," he said. CYT003-QbG10 is a toll-like receptor (TLR) 9 agonist that contains an immunostimulatory sequence of DNA. The rationale for targeting TLR signalling is that it can steer the immune response away from Th2-mediated allergic reactions towards Th1 responses. The double-blind, placebo-controlled, multicentre study included 299 patients diagnosed with persistent (>=2 years) rhinoconjunctivitis due to house dust mites. On average patients had allergies lasting at least 8 years, half were male, and they were aged around 30 years. Patients were recruited by 35 centres in 6 European countries and randomised to receive 0.5 mg or 1 mg of CYT003-QbG10 or placebo. Treatment was given every week for 6 weeks by subcutaneous injection. The primary clinical endpoint was change in the average combined rhinoconjunctivitis symptom and medication score (ACS). This showed greater improvement in the actively treated groups than in the placebo group. At baseline, the median ACS was 0.63 in the placebo group, 0.61 in the 0.5-mg active-treatment group, and 0.60 in the 1.0-mg active-treatment group. At a 2-month repeat assessment, the respective scores were 0.52, 0.45, and 0.31 (P = .035 comparing 1.0 mg CYT003-QbG10 with placebo). Secondary endpoints included quality of life assessed via the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ), and change in allergen tolerance determined by a conjunctival provocation test (CPT) using a solution containing the 2 main house dust mite allergens Der p and Der f before and after therapy. Both of these showed significant improvement with the 1 mg dose of CYT003-QbG10 compared with placebo. "Treatment with CYT003-QbG10 monotherapy was safe and very well tolerated," Dr. Klimek reported. Eight patients quit the study prematurely due to adverse events. Four of these patients had been treated with the 1-mg dose, 3 with the 0.5-mg dose, and 1 patient had been given placebo. Dr. Klimek noted that patients would continue to be followed for 1 year, with repeated ACS, MiniRQLQ, and CPT assessments at weeks 26 and 56. Funding for this study was provided by Cytos Biotechnology AG. [Presentation title: Treatment With CYT003-QbG10, an Allergen-Free Immunomodulator, Reduces Allergic Symptoms in Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy. Abstract 1862]
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