Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
Regulatory and Trading Update
- Successful FDA and Paul Ehrlich Institut meetings on design of Phase III PQ Grass trial, now planned to commence in H2 2020
25 April 2019 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."
This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014.
- ENDS -
For further information, please contact:
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Chief Financial Officer
+44 (0) 20 7886 2500
Freddy Crossley, Emma Earl, Corporate Finance
Erik Anderson, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / David Daley / Nicholas Brown / Olivia Manser
Stern Investor Relations, Inc.
+1 212 362 1200
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an international commercial biotechnology company focussed on the treatment and diagnosis of allergic disorders, including aluminium free immunotherapy vaccines that have the potential to cure disease. The Group sells proprietary and third-party products from its subsidiaries in nine major European countries and via distribution agreements in an additional ten countries. Its broad pipeline of products in clinical development include vaccines for grass, tree and house dust mite, and peanut allergy vaccine in pre-clinical development. Adjuvant systems to boost performance of vaccines outside allergy are also in development.
Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is headquartered in Worthing, UK with more than 11,000m2 of state-of-the-art MHRA-approved manufacturing facilities and laboratories. The Group, which has achieved double digit compound annual growth since formation, employs c.500 employees and is listed on the London Stock Exchange (AIM:AGY). For more information, please see www.allergytherapeutics.com.
About Grass MATA MPL
Grass MATA MPL contains three distinct components: allergoids, micro-crystalline tyrosine (MCT) and monophosphoryl lipid A (MPL®). Allergoids (natural allergens chemically modified to form allergoids) exhibit reduced allergenicity that improves safety and allows for delivery of higher doses. These are combined with the depot adjuvant technology MCT to provide enhanced immune exposure and further improved tolerability.
Finally, the immune response is enhanced and directed by the adjuvant MPL®. MPL is a toll-like 4 receptor (TLR4) agonist which has been extensively used in the Group's other allergy vaccines available on the market and in vaccines registered in the USA.
If approved, the product will be the first registered subcutaneous immunotherapy product in the US for grass allergy.
About US Allergy Market
The US allergy immunotherapy market, which is anticipated to be the main market for this product, is estimated by the Group to be worth $2 billion with potential peak grass vaccine sales of $300-400 million per annum.
1- European Academy of Allergy and Clinical Immunology (EAACI) Global Atlas of Allergy. 2014.
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