Affiliations
Rationale
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.
Methods
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.
Results

In addition, a pivotal phase III DBPC trial was conducted in 2022 with either 10.000 mTU/mL T502 (N=199) or placebo (N=99).
2020 | 2021 | 2022 | |||
---|---|---|---|---|---|
T502-SIT-020 | T502-SIT-041 | ||||
Treatment | N Patients | Treatment | N Patients | Treatment | N Patients |
Placebo | 61 | 10.000 mTU/mL | 141 | 10.000 mTU/mL | 116 |
1.000 mTU/mL | 60 | ||||
3.000 mTU/mL | 60 | ||||
10.000 mTU/mL | 61 | ||||
T502-SIT-045 | |||||
Placebo | 99 | ||||
10.000 mTU/mL | 199 |
Conclusions
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.