Allergy Therapeutics announces that clinical activity on its Pollinex Quattro clinical studies has been placed on clinical hold by the FDA whilst the agency fully assesses the report of a rare adverse event classified by the physician involved as ‘possibly related’ to the study drug.
The Company is collaborating fully with the FDA and has provided extensive data, both as part of the trial routine and supplementary data, including independent expert assessment. Allergy Therapeutics has also reviewed all the data available to it concerning this adverse event, considers that it is unlikely that the event was caused by the study drug and is urgently working with the FDA to provide any additional information necessary to address and resolve FDA’s concerns.
Allergy Therapeutics has two ongoing Pollinex Quattro studies: Phase III Grass (G301) and Phase III Ragweed (R301), and has two about to commence/recommence: the Grass safety study (G302) and a Phase II Tree study (T204). Of these only R301 is directly affected as it is the only trial in the treatment phase.
A full update will be provided as soon as the FDA gives material information on the results of its review. Keith Carter, Chief Executive of Allergy Therapeutics, said, “The FDA has a difficult job to do in minimising risk to patients, both on clinical trials and from marketed pharmaceuticals. It is normal that they should exercise caution. We believe the evidence strongly supports the view that the event was unlikely to have been caused by Pollinex Quattro and we are seeking urgent clarification of the FDA’s position.”
There will be a conference call for analysts at 11.00am. Please dial +44 (0)20 7138 0843 to access the call.
Allergy Therapeutics +44 (0) 1903 845 820 Keith Carter, Chief Executive
Tom Holdich, R&D Director Bridgewell +44 (0) 20 7003 3000
Shaun Dobson Financial Dynamics +44 (0) 207 831 3113
