Allergy Therapeutics (LON:AGY) revealed it is returning to clinical development of Pollinex Quattro Grass - kick-starting the process of getting the firm's first product approved for the US market.
It follows productive discussions with the FDA and the US allergy immunotherapy market is estimated to be worth around US$2 billion.
Pollinex is an injection that inoculates the patient against the irritating and some cases debilitating allergic reaction to grass pollen and the firm has already conducted successful Phase I, II and III programmes, having invested US$100mln so far in its Pollinex Quattro product pipeline and in March this year it raised £20mln to fund the final phase of US clinical development of the candidate. Trials are scheduled to start this September.
Today's news draws a line under the past – a difficult period that followed the US Food & Drug Administration’s (FDA) decision in 2007 to halt development of Pollinex after one patient had an adverse reaction to the grass allergy injection.
Allergy chief executive Manuel Llobet said today: "This is an important and long-awaited milestone for Allergy Therapeutics and I want to thank our investors for their continued support and patience.
"Pollinex Quattro Grass could be the first licensed seasonal subcutaneous immunotherapy allergy treatment, authorised for sale in the US, with the US allergy immunotherapy market estimated at $2 billion.
"We therefore view the prospects for Pollinex Quattro as transformational for the company and we look forward to making a significant contribution to improving the lives of millions of US allergy sufferers."
The firm now expects to submit a Biological Licence Application (BLA) for Pollinex Quattro Grass for US regulatory approval in 2018, assuming the successful completion of the remaining clinical development programme.
Following input on trial design from the FDA, it will initially conduct a small safety study, immediately followed by a Phase IIb study this year, before progressing into a pivotal Phase III study in 2016.
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