Study 08 with CYT003-QbG10 monotherapy included 80 patients suffering from house dust mite and /or cat allergy and investigated the safety, tolerability and efficacy of six injections of ascending doses of CYT003-QbG10 (300-900μg) or placebo. Treatment with CYT003-QbG10 was safe, very well tolerated and significantly reduced rhinoconjunctivitis symptoms in daily life compared to placebo (p=0.008). The CYT003-QbG10 treatment group mean total rhinoconjunctivitis symptom score had fallen from 9.3 points pre-treatment to 3.6 points post-treatment (-61%), whereas for the placebo group a reduction from 9.2 points pre-treatment to 6.3 points post-treatment (-32%) was observed. Also, the allergen tolerance as measured in the conjunctival provocation test was improved after CYT003-QbG10 treatment compared to placebo (borderline significant, p=0.06).
A product with an allergen-independent mechanism of action has major advantages over current immunotherapy approaches, which are all based on allergen components. By nature, allergen extracts can cause severe side effects, which may lead to potentially life-threatening conditions like anaphylaxis. This is why these treatments are contraindicated in those patients who would benefit most from them: People with severe allergies and asthma. In addition, such treatments are usually
administered only by specially trained physicians.
In contrast to this, the almost placebo-like side effect profile of CYT003-QbG10 monotherapy may enable the use of this product in larger patient populations and by general practitioners. Its allergen-independent mechanism of action simplifies treatment, since a single agent can be used for the treatment of multiple allergies. Also, it may be possible to use this product in people for whom immunotherapy is currently contraindicated.
With these major advantages, CYT003-QbG10 has potential to rejuvenate the mature allergic diseases market, which is dominated by either purely symptomatic drugs like antihistamines or corticosteroids or by immunotherapy products containing allergen components. We are therefore excited to advance CYT003-QbG10 monotherapy as a first-in-class, disease-modifying product candidate into late-stage development. Start of phase IIb is planned already in the forth quarter this year.”