09 January 2018
PQ Birch Phase III clinical trial completes recruitment
9 January 2018 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces that recruitment of the Group’s Phase III clinical trial with PQ Birch (PQBirch301) has been completed as expected. 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.
“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.”
Manuel LlobetChief Executive Officer of Allergy Therapeutics
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For further information, please contact:
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Finance Director
+44 (0) 20 7886 2500
Freddy Crossley, Corporate Finance
Tom Salvesen, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / Ivar Milligan / Philippa Gardner
Notes for editors:
About Allergy Therapeutics
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.
Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is headquartered in Worthing, UK with more than 11,000m2 of state-of-the-art MHRA-approved manufacturing facilities and laboratories. The Group, which has achieved double digit compound annual growth since formation, employs c.500 employees and is listed on the London Stock Exchange (AIM:AGY). For more information, please see www.allergytherapeutics.com.
About Pollinex Quattro
Pollinex Quattro is a unique allergen-specific immunotherapy that comprises three key technologies tailored to reduce irritation and systemic reactions; modified allergens, microcrystalline tyrosine (MCT) and Monophosphoryl lipid A (MPL).
The ultra-short duration of Pollinex Quattro is achieved via allergen modification that transforms the structure of allergens to allow increased doses to be delivered compared to traditional unmodified preparations. The potent depot adjuvant, MCT, has a Th1 immunomodulation action that acts in synergy with the TLR4 receptor agonist MPL to augment a shift in the immune reactions responsible for the symptoms of allergic rhinitis.
1 DataMonitor Epidemiology Report. 2011