Allergy Therapeutics PLC (LON:AGY) has confirmed phase III trials of its short-course inoculation for grass pollen-induced hay fever will get underway in the second half of 2020.
This follows a successful round of meetings with both the German and American regulatory authorities that agreed the design and dosing of this pivotal study assessing the efficacy and safety of the aluminium-free immunotherapy.
Insights gained from recent clinical work will also be incorporated into the latest batch of tests, AT said. The trials will be overseen by the US Food & Drug Administration and the Paul Ehrlich Institut in Germany.
Chief executive Manuel Llobet told investors: "With the positive outcomes from our meetings with the FDA and Paul Ehrlich Institut, we have agreed design of our Phase III PQ Grass trial, including patient number requirements and statistical measures.
"Given the sensitivity of clinical trials in allergic rhinitis to the subjective nature of patient-reported outcomes, it is important that we incorporate any potential learnings from our recent trials into the final trial design for PQ Grass.
“Given the PQ Grass trial is expected to commence in the second-half of 2020 we are confident that we have time to amend the protocol accordingly if required.
“This product has the potential to become a much-needed treatment option for the estimated 25-30% of the EU and US populations who are allergic to grass pollen1, and we believe that the PQ Grass trial will enable us to demonstrate the efficacy of this short-course grass pollen immunotherapy."
Well-funded and making progress
In wider update on the company’s pipeline and financial position, AT said a read-out from a phase I clinical assessment of its Acarovac dust mite allergy drug was expected sometime in the current quarter.
Manufacturing scale-up of the Polyvac peanut product is progressing well ahead of a first-in-human study in the first half of next year, it added.
The commercial arm of the business, meanwhile, continued to trade in line with expectations, gaining market share. The company remains well-funded to “progress its commercial and clinical programme into 2021”. As at the end of December AT had just under £32mln in the bank.
"The potential of our pipeline is illustrated by the expected newsflow from our other clinical portfolio programmes and we look forward to updating the market as these progress," said CEO Llobet.