L47
Clinical Development Strategy for Unmet Need in Grass Subcutaneous Immunotherapy
Sunday, March 6, 2016
South Exhibit Hall H (Convention Center)
Tim Higenbottam
Rationale: Grass MATA MPL is an immunotherapy treatment currently in late stage development that addresses the unmet need in the USA of a standardised immunotherapy for seasonal grass allergic rhinitis. This immunotherapy is a modified extract of sweet grasses adsorbed to a depot adjuvant complex containing MCT (micro crystalline tyrosine) and MPL (Monophosphoryl lipid A®) that requires fewer injections than traditional SCIT. To address the challenges in optimal dose evaluation with attention to safety and efficacy, a clinical development model is presented.

Methods: A complimentary battery of phase I to III studies has been conducted to evaluate the relationship of allergen, MCT and MPL combinations in field and EEC (Environmental Exposure Chamber) studies. The effectiveness of allergen immunotherapy is thought to correlate to cumulative dose and the benefit of MCT + MPL has been previously demonstrated with the latter improving efficacy by ~25%. Optimal allergen dose finding was assessed in a combination of field and EEC studies.

Results: A comparative assessment of up dosing of grass MATA MPL in different clinical arms has been completed. The relationship of cumulative dose is presented with consideration of monotonous and non-monotonous dose response including the relevance of dose response plateau and translation to TSS reduction. Ultra-short course treatment (4-6 injections) is compared with prolonged treatment therapy showing increased patient adherence with shorter courses.

Conclusions: The product and clinical development strategy for Grass MATA MPL is presented describing a process to address many of the variables contributing to optimal product efficacy for treatment of grass allergic US patients.