Allergy Therapeutics Announces Positive Top-Line Results From the PQBirch204 Phase II Study for Birch-Induced Seasonal Allergic Rhinitis
(firmenpresse) - WORTHING, UNITED KINGDOM -- (Marketwired) -- 05/09/16 -- Allergy Therapeutics (AIM: AGY)
AIM: AGY
("Allergy Therapeutics" or the "Company")
Primary endpoint met
Statistically significant dose-response relationship (p < 0.01)
All dosing regimens were safe and well tolerated
Adherence was greater than 90%
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.
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.
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Datum: 09.05.2016 - 00:00 Uhr
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