Positive mid-stage trial gives Allergy’s investors some welcome relief

Allergy Therapeutics’ long-stalled efforts to develop a grass pollen allergy candidate finally seem to have lurched into motion, with a positive phase II trial setting up registration trials next year.

Shares in the company leaped on news of the study, which met its primary objective of showing a “highly significant” dose response for the subcutaneously-administered grass pollen vaccine and identifying a dose to take forward into phase III testing, said the UK biotech.

All of the doses were safe and well-tolerated in the 447-patient study, according to Allergy, which was hit hard 11 years ago when the FDA placed its Pollinex Quattro (PQ) grass pollen programme on clinical hold after a patient reported numbness and weakness after taking the drug.

The US regulator - in the throes of a scare about the safety of novel vaccine adjuvants - didn’t relax that hold for five years, and by 2009 the Worthing-based company was hamstrung by debt and burning through cash.

Chief executive Manuel Llobet came on board at that time to launch the turnaround programme, focusing on revenue generation from a portfolio of bee and wasp venom products and allergy diagnostics, making the US regulatory issue a low priority and focusing on developing its European business.

The allergy vaccine pipeline has remained the big prize, however, and the grass pollen allergy candidate the most important in its portfolio. Around 30% of the population in Europe and  a quarter of Americans are allergic to grass pollen.

Two years ago, plans for pivotal trials went awry after an earlier phase II trial failed to identify a suitable dose for late-stage testing, so the latest data means that - at long last - the programme can move forward.

“This study represents a major milestone in our path forward to a registered grass allergy product in Europe,” commented Llobet. “Additionally, this brings us closer towards marketing authorisation in the estimated $2bn US allergy market, a significant opportunity where our product has the potential to be the first registered subcutaneous immunotherapy for the treatment of grass allergy.”

There are already immunotherapies on the market for grass pollen allergy - including for example Alk Abello/Merck & Co’s oral Grazax/Grastek product - but these can take months of treatment to induce tolerance. Allergy says its candidate can be effective within three to eight weeks.

Meanwhile, Allergy’s other pipeline candidates are also making progress, with its PQ birch pollen candidate in a phase III trial in Europe due to read out before the end of the year.