Allergy Therapeutics announces invalidation of the Birch MATA MPL Phase III primary endpoint results

• Technical issues with the endpoint measurements invalidated B301 trial
• New pivotal Phase III Study with Birch MATA MPL to be conducted within TAV time frame

09 July 2020 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today is pleased to announce the outcome of scientific advice from the German Regulatory Authority, the Paul Ehrlich Institute (PEI), regarding invalidation of the primary endpoint data of the Birch MATA MPL pivotal Phase III clinical trial (B301).  

Further to the announcement on 18 March 2019 and following extensive data investigations and discussions with PEI, the analysis of the primary endpoint of the Birch B301 clinical trial has been declared invalid. Technical issues encountered in the study made it impossible to reconstruct the primary endpoint data and the PEI agreed that B301 cannot be considered for assessment of clinical efficacy and a new pivotal Phase III study will be conducted within the therapy allergens ordinance ("Therapieallergene-Verordnung”,TAV) time frame.

The Group’s confidence in its short course immunotherapies remains unchanged and lessons learned from the Birch B301 field study have already been introduced for future studies including the Grass MATA MPL programme to be conducted simultaneously in the US and Europe.

Manuel Llobet, CEO at Allergy Therapeutics, commented: “We are encouraged by our constructive discussions with the PEI who, based upon the clear scientific evidence, decided to invalidate the primary endpoint of the B301 study and agreed to a new pivotal Phase III clinical study for Birch MATA MPL. We remain committed to Birch MATA MPL, especially considering the results of the independent secondary endpoint data and the supportive safety profile observed in the B301 study and two successful phase II trials showing significant primary efficacy results.

“We look forward to progressing our portfolio of unique allergy vaccines and helping the millions of patients affected by allergy via our phase III studies with Birch MATA MPL as well as Grass MATA MPL and our upcoming first in human peanut trial.”

This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014.