Allergy (Pediatric)

June 15, 2015

Aimmune Therapeutics reported results of a phase II study of AR101 for the treatment of peanut allergy. The study, conducted at eight U.S. sites, evaluated 23 patients ages four to 21 who failed a double-blind, placebo-controlled food challenge of less than or equal to 100mg of peanut protein. The randomized, double-blind, placebo-controlled study had 55 patients in the intent-to-treat population, with 29 in the active group and 26 in the placebo group. The active arm had six early discontinuations due to gastrointestinal side effects and compliance issues. All patients who completed the active treatment regimen met the primary endpoint of tolerating a cumulative amount of peanut protein of at least 443mg, compared to five of 26 patients receiving placebo (p≤0.0001). Additionally, 18 of 23 patients who completed the active treatment regimen tolerated a cumulative amount of peanut protein of at least 1,043mg, compared to zero of 26 patients receiving placebo (p≤0.0001). AR101 has been granted Fast Track designation by the FDA. Aimmune Therapeutics plans to initiate a phase III registration trial of AR101 in children and adults.

September 29, 2014

DBV Technologies has reported results of a phase IIb trial of Viaskin Peanut in peanut allergic patients. In the double-blind, placebo-controlled, multicenter trial, 221 patients highly allergic to peanut were randomized to either a 50μg, 100μg or 250μg peanut protein dose of Viaskin Peanut versus placebo. The trial was prospectively organized across the three dose levels with two patient strata composed of three different patient age groups: children (113 subjects ages 6-11) for the first stratum; and adolescents (73 subjects ages 12-17) plus adults (35 subjects ages 18-55) for the other stratum. All patients received a daily application of the Viaskin Peanut patch over a 12-month treatment period. A total of 56 patients were randomized to the Viaskin Peanut 250μg dose. In this arm, 50% of patients responded, compared to 25% in the placebo group, showing statistical significance (p=0.0108). Adolescents showed a trend toward efficacy, showing a response rate of 38.9% in the active arm v. 22.2% in the corresponding placebo group. A statistically significant improvement in the adolescents’ ability to consume peanut protein also was observed, as the LS mean in change of CRD versus placebo of this subgroup was 276mg (p=0.047). The IgG4 increase observed in adolescents, a 3.3 fold increase over 12 months, suggests the beginning of a successful desensitization process.

July 5, 2004

Dynavax Technologies and UCB Pharma have reported positive results of their phase I pediatric trial of AIC, their investigational ragweed allergy vaccine. Results have indicated that the drug is well tolerated in children and adolescents. The dose-escalating, open-label study enrolled 24 children between the ages of 9 and 17, all of whom had documented ragweed allergy; subjects were divided into three dosing cohorts, which each received increasing doses of AIC. Overall safety and tolerability were excellent, with only minor, localized, injection-site reactions reported and no serious adverse incidents. Based on these data, the companies announced plans to extend their clinical investigations into the use of AIC as a prophylactic against ragweed-allergy-induced sequelae, including asthma and chronic sinusitis.