Update to Grass MATA MPL Ph III clinical programme
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
Allergy Therapeutics announces update to Grass MATA MPL phase III clinical programme
26 November 2019 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today provides an update on its Grass MATA MPL phase III study, due to start in Autumn 2020.
Following further investigation of the phase III Birch MATA MPL study (B301), the upcoming Grass study will now take a stepwise approach, with two stages covering both the 2020/2021 and 2021/2022 pollen seasons, rather than the single large trial originally planned for the 2020/2021 season.
The study's stepwise approach has been designed with input from allergy experts. It enables a phase III-scale study to begin in the 2020/2021 season, followed by an interim review to gain insights into the trial, before continuing to the second part of the study.
Results from the Group's successful G205 phase II clinical study, which completed in 2018, evaluating the dose to be taken into phase III, were recently published in the World Allergy Organisation Journal. The paper "Strong dose response after immunotherapy with PQ grass using conjunctival provocation testing" reports that the immunotherapy demonstrated a highly statistically significant (p<0.0001), monotonic dose response for all pre-specified models, which has enabled the Group to acquire agreement from regulatory authorities in Europe and the USA on a target dose for the phase III clinical programme.
Manuel Llobet, CEO of Allergy Therapeutics, said: "The planning for our Grass MATA MPL phase III study is now completed and we look forward to starting this important trial."
This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No.596/2014
- ENDS -
Zielen et al. Strong dose response after immunotherapy with PQ grass using conjunctival provocation testing. World Allergy Organization Journal (2019) 12:100075
For further information, please contact:
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Chief Financial Officer
+44 (0) 20 7886 2500
Freddy Crossley, Emma Earl, Corporate Finance
Erik Anderson, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / David Daley / Nicholas Brown / Olivia Manser
Stern Investor Relations, Inc.
+1 212 362 1200
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an international commercial biotechnology company focussed on the treatment and diagnosis of allergic disorders, including aluminium free 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. Other 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.
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