The PQBirch301 study is a pivotal Phase III study 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.
The successful completion of this pivotal Phase III study would fulfil the requirements for PQ Birch under the Therapieallergene-Verordnung (TAV) of the Paul Ehrlich Institut before anticipated marketing authorisation.
PQ Birch is one of a number of ultra-short course, subcutaneous immunotherapy products in clinical development for various allergies, and these form a key component of the Group's three-pillar growth strategy. This includes: developing a strong pipeline facilitated by investment from the growing, profitable European revenue stream; expanding the existing European business; and preparing for product entry into the US market.
The PQ family of products complement the Group's existing European marketed portfolio of convenient short course subcutaneous immunotherapy products and are particularly suited to the changing regulatory environment for allergy products in the US
Approximately 6% of the population of Europe alone is allergic to birch pollen1 and there continues to be a need for a safe and well tolerated effective treatment for this significant health issue.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "The completion of recruitment in our pivotal Phase III clinical study with PQ Birch is an important milestone for the Group. Marketing authorisation of the first MPL-adjuvanted, ultra-short course aluminium free vaccine available to patients will strengthen the Group's portfolio and help address the current unmet needs in allergy."
Allergy Therapeutics is an international specialty pharmaceutical group focussed on the treatment and diagnosis of allergic disorders, including immunotherapy vaccines that have the potential to cure disease.
The Group sells proprietary and third party products from its subsidiaries in nine major European countries and via distribution agreements in an additional ten countries.
Its broad pipeline of products in clinical development include vaccines for grass, tree and house dust mite, and peanut allergy vaccine in pre-clinical development. Adjuvant systems to boost performance of vaccines outside allergy are also in development.