Allergy Therapeutics has announced the first subject has been dosed in the pivotal phase III G306 trial, to evaluate the efficacy and safety of Grass MATA MPL.
Grass MATA MPL is Allergy Therapeutics’ short-course subcutaneous allergen-specific immunotherapy (SCIT) candidate, which 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). The 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-center, randomized, 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 U.S. 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 Allergy Therapeutics’ Grass MATA MPL during peak grass pollen season.
In addition, the first subjects have been screened and are poised to receive a 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.
Allergy Therapeutics’ production and funding
Allergy Therapeutics said 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 working capital.
Manuel Llobet, CEO of Allergy Therapeutics, said: “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 U.S. 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.”