Detail

Oralair® Grasses 300 IR : Highly positive clinical results in a pharmacodynamic study conducted in an allergen challenge chamber

 

Stallergenes S.A. announces the highly positive results of a new study conducted in an Allergen Challenge Chamber (ACC).

The study on Oralair^® Grasses included 86 adult patients exposed to grass pollen challenge with different treatment durations: 1 week, 1 month, 2 and 4 months without a titration phase. Use of rescue medication was not allowed.

The outcomes of this trial in line with the objectives were:

• An onset of action starting on the seventh day (statistically significant at one month)

• An efficacy plateau reached on challenge at the first month

• A highly statistically significant effect of Oralair^® Grasses versus placebo (p=0.0003) on the average symptom score (RTSS). The magnitude of efficacy (34%)¹ was similar to the findings of the previous studies VO34 (in adults) and VO52 (in a paediatric population)

• A Cohen score of 0.79 corresponding to a large effect size

Safety results, with only well-known local adverse events, and efficacy results were consistent with the findings of Oralair^® Grasses studies previously conducted in adults (VO34) and children (VO52) in phase III trials.

"This study has demonstrated a clear consistency with the outcomes of previous pivotal studies. It opens the way for ACC as a new tool for phase II studies reducing the unpredictability of pollination. Moreover, it confirms the therapeutic effect of Oralair^® Grasses and the very fast onset of action on the symptoms," said Olivier de Beaumont.

¹ on median scores

For full press release, click here.