Cytos Biotechnology Announces Results of its Multicentre Phase II Studies with CYT003-QbG10 Monotherapy
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Cytos Biotechnology Ltd announced results from two randomized, double-blind, placebo-controlled, multicentre phase II studies with CYT003-QbG10 monotherapy for the treatment of house dust mite and cat allergy, and with CYT005-AllQbG10 combination therapy for the treatment of house dust mite allergy.
The studies were conducted in order to determine whether QbG10 acts through an allergen-independent or allergen dependent mechanism of action and to define the strategy for late-stage development of this product candidate.
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).
In study 04, which compared CYT005-AllQbG10 (i.e. the combination of 300µg QbG10 with an approved allergen extract) and the allergen extract alone in 93 patients suffering from house dust mite allergy, reductions of the mean total rhinoconjunctivitis symptom score of -54% for CYT005- AllQbG10 and -51% for the allergen extract were observed (not significant).
The conjunctival provocation test showed a trend in favor of CYT005-AllQbG10 (p=0.11). The total number of suspected adverse events was similar in both treatment arms and was attributed mainly to the presence of the allergen extract (CYT005-AllQbG10: 219 events; approved allergen extract alone: 209 events).
In contrast to this, CYT003-QbG10 monotherapy in study 08 was much better tolerated with a total number of suspected adverse events of only 20 (placebo: 10).
