Allergy Therapeutics plc Phase III clinical trial recruitment completed as expected says Manuel Llobet, CEO

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics LON:AGY, 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 plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announced this morning 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 pollen(1) and there continues to be a need for a safe and well tolerated effective treatment for this significant health issue.

 

Click to view all articles for the EPIC:
Or click to view the full company profile:
Facebook
X
LinkedIn
Allergy therapeutics plc

More articles like this

Allergens dominate UK food recalls, finds study

More than half of food recalls in the United Kingdom over a 5-year period were due to allergens, according to a recently released study. Allergen-related recalls increased annually until 2019, peaking at 118 before decreasing to

Allergy Therapeutics welcomes new Non-Executive Directors

Allergy Therapeutics announced the appointments of Anthony Parker and Simon Shen to its Board as Non-Executive Directors effective immediately. “I would like to welcome Anthony and Simon. Southern Fox and ZQ Capital have been long-standing and supportive shareholders of Allergy

Allergy Therapeutics updates on its clinical programmes

Allergy Therapeutics plc (LON:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, has announced that the first subject has been dosed in the pivotal Phase III G306 trial, to evaluate the efficacy and safety of

Allergy Therapeutics appoints two Non-Executive Directors

Allergy Therapeutics plc (LON:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, has today announced the appointments of Anthony Parker and Zheqing (Simon) Shen as Non-Executive Directors of the Company, with immediate effect. Anthony represents

Allergies and Thanksgiving

As Thanksgiving and other holiday celebrations bring people around the table, Intermountain Healthcare dietitians say it’s crucial to take food allergies into consideration when planning the big meal. “A response to an allergic reaction can be

Allergy Therapeutics appoints Martin Hopcroft as interim CFO

Allergy Therapeutics plc (LON:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, has announced the appointment of Martin Hopcroft to the role of Interim Chief Financial Officer (CFO). Martin will report into Chief Executive

Food business operator fined for allergy breach

A food business operator based in Newcastle, England has been fined in court after serving a dish containing peanuts to a woman with a peanut allergy, resulting in her being hospitalised. According to the Food Standards

Are restaurants taking allergies seriously?

In an engaging panel held at Twickenham Stadium as part of New Food’s Food Safety Conference 2022, experts came together to debate whether food allergy regulations in restaurants are sufficient. Here’s the highlights. Are restaurant allergy

Allergy Therapeutics Subscription to raise £7 million

Allergy Therapeutics plc (LON:AGY), the fully integrated specialty pharmaceutical company specialising in allergy immunotherapy, today announces a conditional Subscription by the Subscribers, Southern Fox and ZQ Capital (acting through its affiliate SkyGem), to raise £7 million