? First ever clinical study to demonstrate the clinical efficacy of allergen peptides in a real-life setting
? gp-ASIT+™ induced a 15% to 21% reduction in the combined clinical symptom and medication score (CSMS) which is considered as satisfactory despite an atypical pollen season
? Identification of a novel mechanism of action for gp-ASIT+TM allows further development and optimization of the ASIT+™ portfolio of product candidates
? Results allow further discussions with regulatory agencies in Germany and the US regarding gp-ASIT+™ clinical development
Brussels, Belgium, 28 February, 2017, 6 PM (CET) – ASIT biotech (Euronext: ASIT - BE0974289218), a Belgian clinical-stage biopharmaceutical company focused on the research, development and future commercialization of breakthrough immunotherapy products for the treatment of allergies, reports positive results for its Phase III clinical trial in grass pollen rhinitis.
The study was conducted in 67 clinical centers in Belgium, the Czech Republic, France, Germany, Italy and Spain, and involved 554 randomized patients.
gp-ASIT+™ consistently improved clinical symptoms and reduced medication use in allergic rhinitis patients by between 15 and 21% compared to placebo, depending on the type of analyses performed (peak vs. entire pollen season, intention-to-treat (ITT) vs. per protocol (PP) population). More specifically, the statistical significance of the primary endpoint, the mean combined clinical symptom and medication (CSMS) score during the peak pollen period, reached p<0.041 using non-parametric testing (Mann-Whitney) and p<0.078 using parametric testing (ANOVA using square root transformation of the scores) on the ITT population. Similar results were obtained when assessing the entire pollen period.
These results confirm:
? the use of the Conjunctival Provocation Test (CPT) as a surrogate marker of clinical efficacy and the reduction in the reactivity score to this test induced by gp-ASIT+™ (p<0.01);
? the induction by gp-ASIT+™ of grass pollen allergen-specific IgG4 and blocking antibodies (assessed on a subset of 32 patients);
? the overall good tolerability of gp-ASIT+™, as demonstrated by the occurrence of mostly mild adverse reactions and the absence of new or unexpected safety findings.
Following additional analyses, full results will be presented at upcoming scientific meetings.
Dr. Mohamed Shamji, Scientific Advisor at ASIT Biotech and Associate Professor at Imperial College London, states: “These positive results are consistent with previous studies performed with gp-ASIT+™ in grass pollen rhinitis, and confirm the efficacy and safety of gp-ASIT+™ in this patient population by activating the regulatory mechanisms of the patient’s immune system. I am delighted to have identified for the first time a novel mechanism of action of gp-ASIT+TM. These findings will be reported in a research article which will be published in a high impact factor scientific journal.”
Thierry Legon, ASIT biotech’s CEO says: “We are pleased to report the first ever clinical study to demonstrate the clinical efficacy of allergen peptides in a real-life setting. This study confirms the effectiveness of our gp- ASIT+™ grass pollen product, and we are looking forward to discussing the detailed results with regulatory agencies in Germany and the US to determine a clear pathway to further clinical development and marketing authorization. Furthermore, the finding of the mechanism of action further supports the development of the ASIT+™ product portfolio targeting house dust mite, ragweed and food allergies. As described in the IPO prospectus, we will explore additional financial opportunities to develop new ASIT+™ products.”
Conference call on 1st March, 2017 at 10:30 AM (CET)
ASIT biotech’s senior management, accompanied by Dr. Mohamed Shamji, Scientific Advisor at ASIT Biotech and Associate Professor at Imperial College London, will hold a conference call in English 1st March, 2017 at 10:30 AM (CET) in order to present its results and answer your questions. To access this conference call, please dial the applicable number:
From France: +33 1 70 77 09 44
From Belgium: +32 2 4040629
From UK: +44 2 033679453
From the United States: +1 6467224908
? gp-ASIT+™ induced a 15% to 21% reduction in the combined clinical symptom and medication score (CSMS) which is considered as satisfactory despite an atypical pollen season
? Identification of a novel mechanism of action for gp-ASIT+TM allows further development and optimization of the ASIT+™ portfolio of product candidates
? Results allow further discussions with regulatory agencies in Germany and the US regarding gp-ASIT+™ clinical development
Brussels, Belgium, 28 February, 2017, 6 PM (CET) – ASIT biotech (Euronext: ASIT - BE0974289218), a Belgian clinical-stage biopharmaceutical company focused on the research, development and future commercialization of breakthrough immunotherapy products for the treatment of allergies, reports positive results for its Phase III clinical trial in grass pollen rhinitis.
The study was conducted in 67 clinical centers in Belgium, the Czech Republic, France, Germany, Italy and Spain, and involved 554 randomized patients.
gp-ASIT+™ consistently improved clinical symptoms and reduced medication use in allergic rhinitis patients by between 15 and 21% compared to placebo, depending on the type of analyses performed (peak vs. entire pollen season, intention-to-treat (ITT) vs. per protocol (PP) population). More specifically, the statistical significance of the primary endpoint, the mean combined clinical symptom and medication (CSMS) score during the peak pollen period, reached p<0.041 using non-parametric testing (Mann-Whitney) and p<0.078 using parametric testing (ANOVA using square root transformation of the scores) on the ITT population. Similar results were obtained when assessing the entire pollen period.
These results confirm:
? the use of the Conjunctival Provocation Test (CPT) as a surrogate marker of clinical efficacy and the reduction in the reactivity score to this test induced by gp-ASIT+™ (p<0.01);
? the induction by gp-ASIT+™ of grass pollen allergen-specific IgG4 and blocking antibodies (assessed on a subset of 32 patients);
? the overall good tolerability of gp-ASIT+™, as demonstrated by the occurrence of mostly mild adverse reactions and the absence of new or unexpected safety findings.
Following additional analyses, full results will be presented at upcoming scientific meetings.
Dr. Mohamed Shamji, Scientific Advisor at ASIT Biotech and Associate Professor at Imperial College London, states: “These positive results are consistent with previous studies performed with gp-ASIT+™ in grass pollen rhinitis, and confirm the efficacy and safety of gp-ASIT+™ in this patient population by activating the regulatory mechanisms of the patient’s immune system. I am delighted to have identified for the first time a novel mechanism of action of gp-ASIT+TM. These findings will be reported in a research article which will be published in a high impact factor scientific journal.”
Thierry Legon, ASIT biotech’s CEO says: “We are pleased to report the first ever clinical study to demonstrate the clinical efficacy of allergen peptides in a real-life setting. This study confirms the effectiveness of our gp- ASIT+™ grass pollen product, and we are looking forward to discussing the detailed results with regulatory agencies in Germany and the US to determine a clear pathway to further clinical development and marketing authorization. Furthermore, the finding of the mechanism of action further supports the development of the ASIT+™ product portfolio targeting house dust mite, ragweed and food allergies. As described in the IPO prospectus, we will explore additional financial opportunities to develop new ASIT+™ products.”
Conference call on 1st March, 2017 at 10:30 AM (CET)
ASIT biotech’s senior management, accompanied by Dr. Mohamed Shamji, Scientific Advisor at ASIT Biotech and Associate Professor at Imperial College London, will hold a conference call in English 1st March, 2017 at 10:30 AM (CET) in order to present its results and answer your questions. To access this conference call, please dial the applicable number:
From France: +33 1 70 77 09 44
From Belgium: +32 2 4040629
From UK: +44 2 033679453
From the United States: +1 6467224908
