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Allergy Therapeutics: sniffing out the potential

It has been a long road to drug approval in the US for the specialist biotech group
September 21, 2017

The US allergy pharmaceuticals market has the potential to be very lucrative. Roughly 18m Americans sniff and itch their way through the hay fever season each year and, at present, treatment options are limited. But it is also a notoriously tricky sector to navigate. Allergy Therapeutics (AGY) is proof of that, gaining the go-ahead for the phase II clinical trial of its new grass allergy medicine – Pollinex Quattro (PQ) – after 10 years. 

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In 2007, Allergy’s final trial into the efficacy of PQ was put on hold after a participant reported numbness and weakening, which regulators couldn’t be sure had nothing to do with the treatment. That hold was only lifted in 2011, and since then the group has failed to show US regulators an acceptable dosage of the drug.

But with demand for PQ so strong, Allergy has been given the go-ahead to try again. The newest dosing study will begin imminently, according to management, and is expected to release results by the second half of 2018. If approved, PQ will be the first injectable allergy treatment available in the US.

But as well as sidestepping tight regulation, Allergy Therapeutics must hurdle another demon of the allergy drugs market: the placebo effect. In 1999 a food allergy vaccine made by Peptide Therapeutics successfully helped 75 per cent of patients on a clinical trial tolerate more of the food they were allergic to. Unfortunately, a similar number of patients on the placebo treatment responded the same way, meaning the trial was deemed a failure. It was a similar story at Circassia (CIR) last year when its cat allergy treatment failed to show any significant benefits above the placebo drug, which had improved symptoms by 59 per cent. Many academic studies have found this high placebo effect to be common in allergy drugs trials, but no-one can fully explain why.

Allergy Therapeutics should be more immune to placebo effect than its peers. PQ has already successfully improved the symptoms of more than 250,000 patients and is marketed in seven countries. Moreover, the trial has not been designed using the self-report measures that have caused problems for many allergy studies; instead patients’ eyes will be observed for signs of improvement before and after treatment.