Date: 2013-09-09
Type of information:
phase: 2a
Announcement: presentation of
Company: Cytos Biotechnology (Switzerland)
Product: CYT003
Action
mechanism: CYT003 is a novel allergen-independent immunotherapy with disease-modifying potential that could be used to treat a broad range of different allergies. In a successfully completed Phase 2a study, this TLR9-agonist was shown to maintain asthma control and lung function and asthma control in patients with persistent allergic asthma, even as standard inhaled corticosteroid treatment was withdrawn. CYT003 has been shown to be safe in over 450 patients to date.
Disease: allergic asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country: Germany
Trial
details: The P2a clinical study is a randomized, double-blind, placebo-controlled trial in patients with persistent allergic asthma requiring long-term treatment with inhaled corticosteroids (ICS). The study took place at five centers in Germany and recruited 63 patients who received 7 weekly to bi-weekly subcutaneous injections, with efficacy assessment during 12 weeks. ICS treatment was withdrawn in two steps from 100% to 50% to 0%. Clinical endpoints included asthma control determined by a validated questionnaire (ACQ), lung function objectively assessed by spirometry (FEV1), day and night-time asthma symptoms and use of relief medication. In addition inflammatory markers (exhaled nitric oxide and eosinophils in the peripheral blood) were evaluated. The study met all clinical endpoints. In patients treated with CYT003 their asthma control improved despite ICS withdrawal. In patients on placebo, the withdrawal of ICS, as expected, led to a worsening of the disease with a statistically significant and clinically important difference between treatment groups. Treatment with CYT003 was safe and generally well tolerated.
Latest
news: The published study is a randomized, double-blind, placebo-controlled trial in patients with persistent allergic asthma requiring long-term treatment with inhaled corticosteroids (ICS). The study took place at five centers in Germany and recruited 63 patients who received 7 weekly to bi-weekly subcutaneous injections, with efficacy assessment during 12 weeks. ICS treatment was withdrawn in two steps from 100% to 50% to 0%. Clinical endpoints included asthma control determined by a validated questionnaire (ACQ), lung function objectively assessed by spirometry (FEV1), day and night-time asthma symptoms and use of relief medication. In addition inflammatory markers (exhaled nitric oxide and eosinophils in the peripheral blood) were evaluated. The study met all clinical endpoints. In patients treated with CYT003 their asthma control improved despite ICS withdrawal. In patients on placebo, the withdrawal of ICS, as expected, led to a worsening of the disease with a statistically significant and clinically important difference between treatment groups. Treatment with CYT003 was safe and generally well tolerated. * On September 9, 2013, Cytos Biotechnology has announced additional results of the phase 2a clinical trial with CYT003, a first-in-class immune modulator in clinical development as a potential new treatment for allergic asthma. A post-hoc analysis of data published in the March issue of The Journal of Allergy and Clinical Immunology are presented at the European Respiratory Society Annual Congress in Barcelona (See below).
The post-hoc analysis looked at TH2 activation assessed by baseline blood eosinophil (bEos) count as predictive marker for a response to the treatment with CYT003 versus placebo. The patients from the Phase 2a study were stratified into the two subgroups based on the median bEos in the overall study population: a lower bEos group was defined with peripheral eosinophils at ?0.1 cells/nL and a higher bEos group was defined with peripheral eosinophils at >0.1 cells/nL.
The results of the post-hoc analysis suggest that the efficacy of CYT003 measured by asthma control, symptoms and medication use, bronchodilation and inflammation markers, is particularly evident in patients with allergic asthma in the higher bEos group. Patients treated with placebo experienced deterioration on all outcome measures, whereas patients treated with CYT003 remained controlled despite ICS withdrawal. In contrast all patients with low bEos remained controlled in spite of steroid withdrawl. This observation suggests that patients in the lower bEos group were not dependent on ICS therapy to achieve adequate control of their asthma. Of particular note, the effect on asthma control and FEV1 in CYT003- compared to placebo-treated patients was more pronounced in the higher bEoS patient subgroup than the reported outcome for the full study. These findings add to the evidence supporting the anti-inflammatory effect of CYT003 and its potential clinical benefit in patients with allergic asthma.
* On March 13, 2013, Cytos Biotechnology has announced the publication of the results from its phase 2a clinical trial with CYT003-QbG10 (CYT003), a first-in-class immune modulator in clinical development as a potential new treatment for allergic asthma. The data are published in the March issue of The Journal of Allergy and Clinical Immunology (JACI) in the article entitled “The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma” by Kai-Michael Beeh, MD, et al. (J Allergy Clin Immunol. 2013 Mar;131(3):866-74).
