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Novartis reported results from a phase III trial of omalizumab for the treatment of chronic idiopathic urticaria (CIU). This global, multi-center, randomized, double-blind, placebo-controlled study, ASTERIA II, enrolled 323 patients with moderate to severe CIU who remained symptomatic despite treatment with approved antihistamine doses. Subjects received omalizumab 75mg, 150mg or 300mg, or placebo, administered subcutaneously every four weeks, for a total of three doses within a 12-week treatment period, with a 16-week follow-up period. The study met its primary endpoint, showing that omalizumab given at doses of 150mg and 300mg led to significant improvement from baseline at Week 12 in the mean weekly ISS from baseline (approximately 14 in all treatment groups) by 8.1 (p=0.001) and 9.8 (p<0.001), respectively, compared to a 5.1 improvement in patients on placebo. The omalizumab 75mg dose group did not demonstrate statistical significance compared to placebo for the primary endpoint. All eight pre-specified secondary endpoints in the ASTERIA II trial were met for the 150mg and 300mg doses. Omalizumab was well tolerated. The more frequent adverse events were nasopharyngitis, idiopathic urticaria and headache. Novartis regulatory submissions are on track for 2013.
Barrier Therapeutics reported positive results from a phase II trial of Hivenyl for the treatment of chronic idiopathic urticaria (CIU). This European based, double-blind, placebo-controlled study enrolled thirty seven subjects with chronic idiopathic urticaria of unknown cause that lasted for a period of at least six weeks. The subjects were randomized to receive Hivenyl 60 mg or placebo once daily for one week. The primary efficacy endpoint, a decrease from baseline in average itch severity score compared to placebo, as measured by patients' evaluations, was reached (p=0.037). Overall assessment by both the subjects and the physicians of Hivenyl's effectiveness in treating CIU compared to placebo was statistically significant (p=0.020 and 0.012, respectively). Hivenyl was well tolerated and no signs of sedation were reported. Based on the results Barrier Therapeutics plans to move forward with the development of Hivenyl.