The aim of a drug development program for allergen immunotherapies is to get market authorization based on a good efficacy and safety/tolerability profile. Here, we describe the clinical development of Mannan conjugated birch pollen allergoids (T502) for the treatment of allergic rhinitis/rhinoconjunctivitis.
The Phase IIa study was planned as a first-in-human DBPC dose finding hybrid study, which covered both, safety/tolerability and efficacy. The second trial was then conducted as an open Phase II/III study with patients from the first study, with all patients being treated with the most effective dose. The third (Phase III) trial was also designed as a DBPC trial in a larger patient population.
Early efficacy data can be collected already in a dose-finding study. Through the subsequent open design, further data on safety, tolerability and efficacy can be collected.
This work was funded by Inmunotek S.L.