SOURCE: Allergy Therapeutics PLC

May 09, 2016 02:00 ET

Allergy Therapeutics Announces Positive Top-Line Results From the PQBirch204 Phase II Study for Birch-Induced Seasonal Allergic Rhinitis

WORTHING, UNITED KINGDOM--(Marketwired - May 9, 2016) - Allergy Therapeutics (AIM: AGY)


9 May 2016

Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Allergy Therapeutics announces positive top-line results from the PQBirch204 Phase II study for birch-induced seasonal allergic rhinitis

  • 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.

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.

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Contact Information

  • For further information, please contact:

    Allergy Therapeutics
    +44 (0) 1903 845 820
    Manuel Llobet
    Chief Executive Officer

    Panmure Gordon
    +44 (0) 20 7886 2500
    Freddy Crossley / Peter Steel / Duncan Monteith, Corporate Finance
    Tom Salvesen, Corporate Broking

    Consilium Strategic Communications
    +44 20 3709 5700
    Mary-Jane Elliott / Ivar Milligan / Matthew Neal / Laura Thornton