FDA Clinical Hold Lifted - Phase III Study Agreed
Allergy Therapeutics plc, (AIM: Allergy or the "Company"), the specialist pharmaceutical company focused on allergy vaccination, today announces that the FDA has confirmed that the clinical hold in the US dated 2007 has now been lifted on the Company's grass pollen allergy vaccine (Grass MATA MPL/ Pollinex® Quattro Grass 0.5ml) clinical development programme, with immediate effect. Allergy has gained approval to progress with a Phase III efficacy study, to be conducted in an Environmental Exposure Chamber ("EEC"). The Company is now focused on securing a partner to commercialise Pollinex Quattro in the US.
Allergy is planning to progress phase III development of their ultra short course allergy vaccines in the US. These 'four shot' products are based on the adjuvant MPL®, the Company's innovative TLR4-agonist which acts to stimulate and re-direct the immune response. The Pollinex Quattro allergy vaccines, which are already commercialised in a number of European countries under a named patient basis, require only four injections per year and have the potential to transform allergy treatment in the US, providing a convenient, safe, and effective vaccination to allergic rhinitis sufferers.
The FDA's decision to lift the clinical hold marks an important step in the development of Pollinex Quattro for the treatment of grass allergy in the US.
Manuel Llobet, Chief Executive Officer, commented:
"We are pleased that the FDA has decided to lift the clinical hold on our Pollinex Quattro programme. This product has the potential to greatly benefit allergy sufferers in the US in the absence of registered products by being the first subcutaneous immunotherapy vaccine to reach the US market. Additionally, lifting of the hold will allow for discussions with potential partners with whom we will finalise the clinical development and start the commercialisation of Pollinex Quattro in a market estimated to be around US$ 2 billion."
Lawrence DuBuske MD, Clinical Professor of Medicine at George Washington University School of Medicine, Washington, DC, principal investigator for the previous phase III study (G301) of the Company's Grass MATA MPL product, the largest ever allergy immunotherapy study to be undertaken, commented:
"Grass MATA MPL could revolutionise treatment for grass related allergic rhinitis in the US by providing effective, fast-acting treatment to allergy sufferers. The product involves four pre-seasonal allergy vaccine injections administered over a month,making itan attractive alternative to the prolonged course of weekly to monthly injections over three years that is currently availablewith the allergen extract vaccines used in the United States. There are many patients who decline injections offered by allergists, due to the time commitment and safety concernswhen using the typical allergen vaccines now available."