StockMarketWire.com - Allergy Therapeutics has announced positive top-line results from the PQBirch204 phase II study for birch-induced seasonal allergic rhinitis.

Allergy Therapeutics said 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 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.

Chief executive Manuel Llobet said: "The results of the PQBirch204 trial are very encouraging and they reaffirm the potential of our Pollinex platform to treat the underlying cause of allergic rhinitis. Approximately 6% of the population in Europe alone is allergic to birch pollen and there continues to be a need for a safe and well tolerated effective treatment for this significant health issue. Pollinex is the only ultra-short course aluminium-free treatment in the market and its convenience for patients is driving our market penetration in all our European markets.

"This study is a significant milestone in our route to Marketing Authorisation and keeps us on track to commence the Phase III study in early 2017."






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