Allergy Therapeutics completes recruitment for clinical study
Source - SMW
Allergy Therapeutics said recruitment of the group's phase III clinical trial with PQ Birch (PQBirch301) has been completed as expected.
The PQBirch301 study is designed to evaluate the safety and efficacy of the group's ultra-short course, convenient for patients, aluminium free PQ Birch subcutaneous immunotherapy to address the cause of symptoms of allergic rhinoconjunctivitis due to birch pollen.
The PQBirch301 study has randomised over 560 patients from 59 centres in four European countries: Germany, Austria, Poland and Sweden.
The primary efficacy data will be assessed during the birch pollen season of 2018 and the results of the trial are expected during H2 2018.
Allergy Therapeutics said successful completion of this pivotal study would fulfil the requirements for PQ Birch under the Therapieallergene-Verordnung (TAV) of the Paul Ehrlich Institut before anticipated marketing authorisation. The group said that approximately 6% of the population of 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.