27th Jun 2016 09:06
LONDON (Alliance News) - Allergy Therapeutics PLC on Monday said the results of its Phase II dose-ranging study for the US GrassMATAMPL clinical development programme did not determine a recommended dose for the Phase III trial.
GrassMATAMPL is an ultra-short-course subcutaneous allergen-specific immunotherapy, administered prior to the grass pollen season.
The allergy vaccine specialist said a further dose range finding study will be implemented prior to proceeding into the planned pivotal Phase III study. The next dose-range finding study is planned to start in 2017, and Allergy Therapeutics will await the outcome of an End of Phase II meeting with the US Food & Drug Administration later in 2016 before progressing into Phase III.
"Defining the optimal dose is part of late-stage product development, and we will revisit dose evaluation as we recently successfully did with our PQ Birch product, using two separate and complimentary dose-ranging studies. Additionally, the new findings of our Phase II EEC study will need to be discussed with FDA before deciding on the recommended dose for the following Phase III registration trial. While still being determined to become the first company to introduce SCIT to the US, a deferred entry time into the market is now anticipated," Chief Executive Manuel Llobet said in a statement.
Allergy Therapeutics added that it has achieved 19% constant currency revenue growth in Europe in 2016 to date, faster than the 12% constant currency growth it achieved in the year to December 2015.
"We are progressing with our plans and are very excited by the prospects of building a leading subcutaneous company in Europe as well as in international markets," Llobet said.
Shares in Allergy Therapeutics were trading down 15% at 19.99 pence on Monday morning.
By Karolina Kaminska; [email protected] @KarolinaAllNews
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