Allergy Therapeutics plc B301 Phase III results highly statistically significant

Manuel Llobet, CEO at Allergy Therapeutics, stated: “We are surprised by the result, given the strong immune response suggested by the increased immunoglobulin markers in the treatment arm and the substantial symptom improvement we had observed in earlier trials. We will now undertake a comprehensive review of the full dataset to determine our path forward with the investigational product. As a science-driven company we are conscious at Allergy Therapeutics of the challenges regarding subjective measures in allergy field studies. We are committed to overcoming these challenges and bringing this new product to market.”

Allergy Therapeutics plc (LON: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announced top-line results from the Phase III clinical trial B301of its new adjuvanted birch allergoid product. The trial did not show a statistically significant difference between active and placebo arms in the primary endpoint of a combined symptom medication score averaged over the peak birch pollen season. The safety and tolerability profile was positive and consistent with that observed in previous trials. Importantly, secondary endpoint analyses of immunoglobulin markers including IgG and IgG4 showed highly statistically significant differences between active and placebo, suggesting a strong and sustained immune response to treatment (p <0.0001).

Allergy Therapeutics has extensive experience with other approved and commercialized birch products. Since 2010, the investigational product has undergone two successful Phase II trials where a highly statistically significant 32% reduction in allergic symptoms between the active and placebo was observed. The Group will undertake a review of the full trial dataset to understand any cause for the lack of consistency in the clinical outcomes seen between the studies.

The B301 trial was a multi-centre, double-blind, placebo-controlled study designed to test the efficacy in birch-pollen induced seasonal allergic rhinitis. The European study took place in Germany, Poland, Austria and Sweden with 582 patients over 59 centres being randomised into active and placebo arms, to evaluate the safety and efficacy measured as a reduction in allergic symptoms as determined by the combined symptom medication score.

Click to view all articles for the EPIC:
Or click to view the full company profile:
Facebook
Twitter
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