StockMarketWire.com - Allergy Therapeutics has completed randomisation with 364 patients entered into the PQBirch204 double-blind, placebo-controlled dose selection study for the specific subcutaneous immunotherapy (SCIT), Pollinex Quattro Birch.

The target sample size of 350 patients randomised into 6 dosage arms and placebo has been successfully achieved, ending the recruitment phase of this study. PQBirch204 is planned to complete by February with results available in Q2 2016. The endpoint of the trial is change in total rhynoconjunctival system score over baseline compared to placebo. The dose established as most efficacious, safe and tolerable will be selected and studied in the PQBirch phase III study, due to start in Q1 2017.

The completion of the phase III study is expected to fulfil the requirements for the initial clinical programme under the Therapy Allergens Ordinance of the Paul Ehrlich Institute, the European Biologics Agency, and lead to Marketing Authorisation Approval of this SCIT in 2019.




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