Allergy Therapeutics PLC (LON:AGY) has been granted the opportunity to carry out a new phase III clinical study on its short-course birch pollen inoculation after a tranche of data was declared invalid.
In March, it was revealed Birch MATA MPL had failed to reach what in the technical jargon is referred to as its primary endpoint. In layman’s terms it didn’t appear to provide therapeutic value.
However, at the time there Allergy Therapeutics hinted at contradictory results from the study.
Specifically, the researchers found that there was a “highly statistically significant” differences in immunoglobulin markers between the group receiving the treatment and those not that was suggestive of a “sustained immune response”.
The company has since taken advice from the Paul Ehrlich Institute (PEI), the scientific regulator for Germany where the trial was carried out, which has agreed that a new phase III trial can be conducted.
“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,” Allergy Therapeutics chief executive Manuel Llobet said in a statement.
“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,” he added.
Published at Thu, 09 Jul 2020 06:36:00 +0000-Allergy Therapeutics allowed to hit the reset button on birch pollen phase III trial