ASIT Biotech recently announced that its second Phase III trial of gp-ASIT, an ultra-short course, grass pollen-specific, subcutaneous immunotherapy (SCIT) product, failed to meet the primary endpoint of a 20% reduction in the combined symptom and medication score (CSMS) during peak grass pollen season. Considering the company’s success in a previous Phase III trial, this failure is unexpected and represents a major opportunity for Allergy Therapeutics’ competing pipeline agent, Grass MATA MPL, says GlobalData, a leading data and analytics company.

GlobalData’s report, ‘Allergic Rhinitis: Opportunity Analysis and Forecasts to 2028’, forecasts for gp-ASIT to launch in the *5EU in 2022 and reach sales of $30.5m in 2028, representing 14% of the European grass pollen allergen-specific immunotherapy (ASIT) market.

Rose Joachim, Senior Healthcare Analyst at GlobalData, commented: “There is a growing desire in Europe for grass pollen ASIT products with formal marketing authorization (MA). Thus, it is likely that the projected sales for gp-ASIT will be absorbed by other players in the pipeline, namely Allergy Therapeutics’ Grass MATA MPL.”

Grass MATA MPL, previously known as Pollinex Quattro Grass, has been used for decades in Europe as a named patient product and was esteemed by European key opinion leaders (KOLs) interviewed by GlobalData. Currently, Allergy Therapeutics is developing a new, stronger, six-dose formulation of the product for which it is pursuing MA in the US and Europe.

Joachim continues: “Although the formulation has recently changed as a part of Allergy Therapeutics’ efforts to gain formal MA in the US and Europe, this change could really be promising. It comes as a result of a recent dose-finding study that demonstrated improved efficacy and similar safety when using a higher cumulative dose of allergen spread out over more numerous injections.”

Although GlobalData believes Grass MATA MPL is a promising therapeutic candidate, there is a significant chance its upcoming Phase III trial might befall the same fate as gp-ASIT. In March 2019, Allergy Therapeutics’ Phase III program for Birch MATA MPL (Pollinex Quattro Birch) also failed to meet its primary endpoint following a successful Phase II program. However, based on a recent announcement, Allergy Therapeutics appears prepared to address these concerns.

Joachim explains: “The environmental exposure-based efficacy endpoints required in registrational trials for ASIT products contribute a great deal of complexity and uncertainty. Due to this, Allergy Therapeutics is planning to take a step-wise approach in its Phase III Grass MATA MPL study, breaking it into two smaller studies covering both the 2020-2021 and 2021-2022 pollen seasons. This could be an effective strategy, as the interim analysis following the 2020-2021 season might allow the company to correct for unforeseen environmental factors and other issues with study design.”

*5EU = France, Germany, Italy, Spain, and the UK