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Primary endpoint met
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Statistically significant dose-response relationship (p < 0.01)
-
All dosing regimens were safe and well tolerated
-
Adherence was greater than 90%
WORTHING, UK I May 9, 2016 I Allergy Therapeutics, (AIM: AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces positive top-line results from the Company’s PQBirch204 Phase II study, a multi-centre, double-blind, placebo-controlled study designed to explore the safety and response of different cumulative doses of Birch Modified Allergen Tyrosine adsorbed and MPL® (POLLINEX® Quattro Birch) for birch pollen induced seasonal allergic rhinitis.
The study randomised 371 patients into six cumulative dosing regimens plus a placebo, evaluating the change in Total Symptom Score (TSS) following a conjunctival provocation test (CPT) with the objective to achieve a dose recommended for Phase III development.
Results summary of the PQBirch 204 Phase II study programme
- The primary endpoint, to demonstrate a statistically significant (p < 0.01) dose-response for the 5000 standardised units (SU) to 27300 SU, was met. This enables prediction of the dose to enter Phase III development
- The study demonstrated a statistically significant (p < 0.01) dose-response for the 5000 standardised units (SU) to 27300SU dose range studied
- The dose-response closely followed and extended the findings of the previous dose-response study (PQBirch203), which studied doses from 600SU to 13600SU
- PQBirch continues to be well-tolerated and no safety concerns were reported in any treatment arm. There was no significant relationship between any adverse drug reaction exhibited and the respective dosage of allergoid
- Overall adherence to the dosing regimens was approximately 94% with no relevant differences between treatment arms.
SOURCE: Allergy Therapeutics
Post Views: 295
-
Primary endpoint met
-
Statistically significant dose-response relationship (p < 0.01)
-
All dosing regimens were safe and well tolerated
-
Adherence was greater than 90%
WORTHING, UK I May 9, 2016 I Allergy Therapeutics, (AIM: AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces positive top-line results from the Company’s PQBirch204 Phase II study, a multi-centre, double-blind, placebo-controlled study designed to explore the safety and response of different cumulative doses of Birch Modified Allergen Tyrosine adsorbed and MPL® (POLLINEX® Quattro Birch) for birch pollen induced seasonal allergic rhinitis.
The study randomised 371 patients into six cumulative dosing regimens plus a placebo, evaluating the change in Total Symptom Score (TSS) following a conjunctival provocation test (CPT) with the objective to achieve a dose recommended for Phase III development.
Results summary of the PQBirch 204 Phase II study programme
- The primary endpoint, to demonstrate a statistically significant (p < 0.01) dose-response for the 5000 standardised units (SU) to 27300 SU, was met. This enables prediction of the dose to enter Phase III development
- The study demonstrated a statistically significant (p < 0.01) dose-response for the 5000 standardised units (SU) to 27300SU dose range studied
- The dose-response closely followed and extended the findings of the previous dose-response study (PQBirch203), which studied doses from 600SU to 13600SU
- PQBirch continues to be well-tolerated and no safety concerns were reported in any treatment arm. There was no significant relationship between any adverse drug reaction exhibited and the respective dosage of allergoid
- Overall adherence to the dosing regimens was approximately 94% with no relevant differences between treatment arms.
SOURCE: Allergy Therapeutics
Post Views: 295
