Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces the outcome of successful discussions with the Paul Ehrlich Institut (PEI) in Germany and the Food and Drug Administration (FDA) in the US regarding the pivotal Phase III PQ Grass trial design. The trial, being planned for the US and Europe, will evaluate the efficacy and safety of the Group’s short course, aluminium-free pre-seasonal immunotherapy in the prevention of the symptoms of allergic rhinoconjunctivitis caused by grass pollen.
The Group presented positive results from its Phase II PQ Grass trial to the PEI and FDA and agreement was reached on the dose to progress into Phase III, as well as other essential features of the trial design. Accordingly, in order to finalise the design of the trial and incorporate the latest clinical evidence, the trial is expected to commence in H2 2020, to be aligned with the 2020/2021 allergy season.
The Group continues to make good progress with its broad clinical pipeline. A readout of the Phase I Acarovac MPL trial for house dust mite allergies is expected in Q2 2019. Manufacturing scale-up of the Group’s Polyvac Peanut product, which is critical to ensure commercial manufacture in a consistent manner for clinical trials and in GMP conditions, is progressing well. The Phase I first-in-human trial for Polyvac Peanut is now expected in H1 2020 as we complete the pre-clinical work in advance of human dosing next year.
The commercial business continues to trade in line with market expectations and gain market share, and the Group remains well-funded to progress its commercial and clinical programme into 2021. As announced in the 6 March 2019 Interim Results, the Group had a cash balance of £31.6m at 31 December 2018.
Manuel Llobet, CEO at Allergy Therapeutics, stated: “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 H2 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.
“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.”