Allergy Therapeutics PLC (AIM:AGY, OTC:AGYTF) marked a 'significant milestone' after it applied for regulatory approval of its new grass allergy immunotherapy.
The submission, made to Germany’s Paul Ehrlich Institut (PEI), includes evidence from a phase III clinical trial showing significant symptom reduction during peak pollen season.
The therapy, called Grass MATA MPL, is an injectable treatment targeting allergic rhinoconjunctivitis caused by grass pollen.
It combines modified allergenic extracts with innovative components to reduce allergic responses and requires only six injections before allergy season.
The application is now undergoing validation, after which the PEI will begin its review.
It includes safety, quality, and efficacy data from trials, including the G306 study. This study showed a clear reduction in allergy symptoms and medication use compared to a placebo.
If approved, Grass MATA MPL could offer an effective option for people with grass pollen allergies, addressing the root cause rather than just the symptoms. The company expects the formal review to start soon following the institute’s standard validation process.
"The submission of the MAA to the PEI in Germany marks a significant milestone in our regulatory pathway and brings us closer to potentially offering an important new treatment option for patients affected by seasonal grass allergy," said Manuel Llobet, CEO of Allergy Therapeutics.
"We look forward to continuing to work closely with the PEI during the review process of the MAA and I would like to thank the team at Allergy Therapeutics for their dedication in advancing this innovative product toward market."