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(Sharecast News) - Biotechnology company Allergy Therapeutics announced the outcome of scientific advice from the German Regulatory Authority, the Paul Ehrlich Institute (PEI), over invalidation of the primary endpoint data of the Birch MATA MPL pivotal phase 3 clinical trial, or 'B301', on Thursday.
The AIM-traded firm said that, following "extensive" data investigations and discussions with PEI, the analysis of the primary endpoint had been declared invalid.
Technical issues encountered in the study made it impossible to reconstruct the primary endpoint data, the board said, and the PEI agreed that B301 could not be considered for the assessment of clinical efficacy.
A new pivotal phase 3 study would be conducted within the therapy allergens ordinance time frame, it explained.
The group said its confidence in its short course immunotherapies remained unchanged, adding that the lessons learned from the Birch B301 field study had already been introduced for future studies, including the Grass MATA MPL programme, to be conducted simultaneously in the US and Europe.
"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 3 clinical study for Birch MATA MPL," said chief executive officer Manuel Llobet.
"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 2 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 3 studies with Birch MATA MPL as well as Grass MATA MPL and our upcoming first in human peanut trial."
At 1558 BST, shares in Allergy Therapeutics were down 1.59% at 13.9p.
7 May 2024 20:22
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