DYNAVAX'S RAGWEED ALLERGY TRIAL RESULTS NOT SIGNIFICANT

Dynavax Technologies has announced that the analysis of interim one-year data from its two-year DARTT ragweed allergy trial indicated that no meaningful ragweed-specific allergic disease was observed in the study population, making it impossible to measure the therapeutic effect of Tolamba treatment.

DARTT is a 30-center, placebo-controlled study in 738 ragweed allergic subjects ages 18 to 55. In all three arms of the study, including the placebo arm, minimal change from baseline was observed in the main efficacy measure of the study, the total nasal symptom score (TNSS). The company indicated that in the placebo and treated groups, the change from baseline TNSS was very low, not clinically significant, and substantially lower than what has been observed in prior trials.

"In effect, we saw three patient groups with no measurable disease during the ragweed season. This result was unexpected, though these challenges are well known to occur in allergy drug development. Due to the fact that no clinically significant disease was seen in the study population, it was impossible to measure the effect of our intervention," Dino Dina, president and CEO of Dynavax, said.

Tolamba consists of Dynavax's proprietary immunostimulatory sequences (ISS) linked to the purified major allergen of ragweed, called Amb a 1. Tolamba is designed to target the underlying cause of seasonal allergic rhinitis caused by ragweed. The linking of ISS to Amb a 1 ensures that both ISS and ragweed allergen are presented simultaneously to the same immune cells, producing a highly specific and potent inhibitory effect and suppressing the Th2 cells responsible for inflammation associated with ragweed allergy, according to the company.