Table 1.
Overview of the most recent products for which Phase II have been performed with EEC and provocation tests and the pivotal Phase III study has been completed.
| Route/Ref. | Allergen source | Allergen preparation | Model | Phase II result(s) End-point/main result |
Phase III End-point/main results |
|---|---|---|---|---|---|
| SCIT6,7 | Grass pollen | Peptide | CPT | 25.6% improved thresholds by at least one concentration step compared to placebo (p = 0.023) | CSMS -15.5% (P = 0.041) |
| SCIT8,9 | Cat | Peptide | Exposure chamber | 28.3% improvement from placebo (p = 0.01) | Combined Score −1.3% (P = 0.439) |
| SCIT10,11 | HDM | Peptide | CPT | Highest effect size −36.7% (p = 0.026) | Combined Score −4.2% (P = 0.26) |
| SCIT12 | HDM | Allergoid | NPT | Highest effect size −48.1% (p < 0.0001) | CSMS -9.2% EudraCT2016-000051-27 |
| SCIT13 | Birch pollen | Allergoid with adjuvants MCT and MPL | CPT | Highest dose −32.3% (p < 0.001) | Phase III study completed in 2018 – PEI agreement that primary end-point was invalidated due to technical issues making it impossible to reconstruct primary end-point data |
| SLITa,14,15 | Birch pollen | Drops (non-modified) | NPT | Highest effect size −58.4% (p < 0.0001) | CSMS, - 32% (p < 0.0001) |
| SLITa,16,17 | HDM | Tablet | Exposure chamber | Highest effect size −48.6% (p < 0.001) | Total combined rhinitis score −18% (p = 0.01) |
a
Product has received marketing authorization status and/or US licensure; CPT = conjunctival provocation test; CSMS = combined symptom and medication score; HDM = house dust mite; NPT = nasal provocation test; PEI= Paul Ehrlich Institute; Ref. = Reference; SCIT = subcutaneous immunotherapy; SLIT = sublingual immunotherapy