Allergy Therapeutics (LON:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announced 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.
- 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
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.”
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.
Allergy Therapeutics plc 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 (LON: AGY).
