Last checked at 8 Dec 2022 07:00
Allergy Therapeutics plc
("Allergy Therapeutics", "ATL" or the "Group")
Allergy Therapeutics announces key updates on Grass MATA MPLand VLP Peanut clinical programmes
Update on production and funding
- Innovative short-course grass pollen immunotherapy with best-in-class potential
- If successful, Grass MATA MPL will be the first subcutaneous and aluminium‑free short-course allergy immunotherapy approved in the US
- Topline safety & efficacy data for Grass MATA MPL expected Q4 2023
- Safety, tolerability and efficacy data for VLP peanut expected 2023
8 December 2022 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces that the first subject has been dosed in the pivotal Phase III G306 trial, to evaluate the efficacy and safety of Grass MATA MPL, the Group's short-course subcutaneous allergen-specific immunotherapy (SCIT) candidate, that aims to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen.
Grass MATA MPL incorporates MicroCrystalline Tyrosine ("MCT®") adsorbed allergoids, and the innovative adjuvant Monophosphoryl-lipid A ("MPL"). This innovative technology only requires patients to receive six injections prior to the grass allergy season to be protected.
The pivotal Phase III G306 trial is a multi-centre, randomised, parallel group, double-blind, placebo-controlled clinical trial to confirm the efficacy and safety of Grass MATA MPL. The clinical trial will be conducted in the US and Europe at approximately 120 clinical trial sites. Data readout is planned for Q4 2023.
Previously announced top-line results from the G309 exploratory field trial showed meaningful and statistically significant reductions in symptoms due to grass pollen allergy and in the use of relief medications after six SCIT injections with Grass MATA MPL during peak grass pollen season.
In addition, the first subjects have been screened and are poised to receive the Group's innovative, short-course peanut allergy vaccine candidate, VLP Peanut in the Phase I PROTECT trial. The first-in-human study is evaluating the safety and tolerability of VLP Peanut in healthy and peanut allergic adult subjects and exploring preliminary proof of efficacy. Plans remain on track for data in 2023.
Update on production and funding
Further to the announcement on the 28th October, work is continuing on cost control and tight capital management following the impact of the pause in production. This includes reviewing all funding options and managing the working capital of the Group.
Manuel Llobet, CEO of Allergy Therapeutics, commented: "The start of our pivotal Phase III G306 trial investigating the efficacy and safety of our Grass MATA MPL marks the culmination of our efforts to bring this innovative treatment to millions of patients affected by grass allergies in both the US and Europe. We were encouraged by the results of our short-course grass pollen immunotherapy in the highly successful G309 exploratory field trial and look forward to advancing the development of this innovative treatment. The start of the VLP Peanut PROTECT trial is a significant milestone and a testament to the hard work of the Allergy Therapeutics team, developing innovative approaches that have the potential to transform the way we treat and manage allergies."
More information about the Phase III G306 Grass MATA MPL trial can be found on ClinicalTrials.gov under the identifier NCT05540717.
About Grass MATA MPL
Grass MATA MPL is being developed as a pre-seasonal subcutaneous immunotherapy product for the treatment of allergic rhinitis and/or rhinoconjunctivitis.
Grass MATA MPL contains an extract of 13 grass pollens modified with glutaraldehyde to form allergoids that reduces the reactivity with immunoglobulin E (IgE) antibodies without a reduction in other important immunological properties, such as T-cell reactivity. The allergoid is adsorbed to microcrystalline tyrosine as a depot adjuvant system formulation. Monophosphoryl lipid-A (MPL), is included as an adjuvant to increase the immunogenic effect of the immunotherapy and to enhance the switch from an allergen specific helper T-cell Type 2 (Th2) to helper T-cell Type 1 (Th1) like immune response.
This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014.
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For further information, please contact:
Allergy Therapeutics
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Chief Financial Officer
Panmure Gordon (Nominated Adviser and Broker)
+44 (0) 20 7886 2500
Freddy Crossley, Emma Earl, Corporate Finance
Rupert Dearden, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / David Daley / Davide Salvi
allergytherapeutics@consilium-comms.com
Stern Investor Relations, Inc.
+1 212 362 1200
Christina Tartaglia
christina@sternir.com
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 includes 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 employs c.600 employees, is listed on the London Stock Exchange (AIM:AGY). For more information, please see www.allergytherapeutics.com.