Novartis has reported new results from the phase III ASTERIA I study showing omalizumab was effective and safe in the treatment of chronic spontaneous urticaria (CSU), a chronic and debilitating form of hives. ASTERIA I is the final pivotal registration study for omalizumab in CSU to be presented for the first time at the 22nd Congress of the European Association of Dermatology and Venereology (EADV) in Istanbul, Turkey.

Omalizumab is currently not approved for the treatment of CSU.

The ASTERIA I data support the positive and consistent results from two previously reported pivotal Phase III registration studies of omalizumab in CSU (ASTERIA II and GLACIAL), which were presented at major medical congresses earlier this year. Regulatory applications for omalizumab in CSU were filed with US and EU health authorities in the third quarter of 2013, based on data from nearly 1,000 patients included in these phase III studies.

"The positive new data clearly show the potential of omalizumab to treat CSU, a disease where more than 50 per cent of patients don't respond to approved doses of antihistamines, the only licensed treatment option," said Tim Wright, global head of Development, Novartis Pharmaceuticals. "With submissions to EU and US regulatory authorities now completed, we are on track to bring omalizumab to people suffering from this chronic and debilitating disease."

Specifically, the ASTERIA I study showed that patients treated with omalizumab responded as early as Week 1 (300 mg dose), compared to Week 4 in the placebo group (p=<0.0001). By Week 12 all three omalizumab doses (300 mg, 150 mg and 75 mg) were significantly superior to placebo in improving patients' weekly Itch Severity Score (ISS), which was the primary endpoint of the study. This benefit was maintained throughout active treatment (Week 24).

The study also showed patients treated with omalizumab 300 mg experienced nearly twice the improvement in their quality of life compared to those taking placebo by Week 12 (p<0.0001). Quality of life measures are critical to assessing CSU treatments, because the disease can frequently lead to other negative consequences such as sleep deprivation, depression and anxiety.

In addition, by Week 12 more than half (52 per cent) of omalizumab 300 mg patients in the study had their CSU symptoms (itch, hives) well controlled and 36 per cent had no symptoms at all (p<0.0001). At the same time point, omalizumab 300 mg treated patients also experienced a significant increase in the proportion of days free of deep tissue swelling, also known as angioedema (p<0.0001).

The study met all pre-specified secondary efficacy endpoints for omalizumab 300 mg and 150 mg compared to placebo, except the 150 mg group did not reach statistical significance versus placebo for the quality of life measurement at Week 12.

The incidence and severity of adverse events (AEs) was similar across all ASTERIA I treatment groups. Five omalizumab patients experienced serious AEs during the treatment period (75 mg group n=2, 150 mg group n=3, 300 mg group n=0), compared to four patients in the placebo group. No deaths were reported during this study.

ASTERIA I was a 40-week, global, multi-center, randomized double-blind study that evaluated the efficacy and safety of omalizumab compared to placebo. It involved 318 patients between the ages of 12 and 75 with moderate-to-severe CSU who remained symptomatic despite prior treatment with H1 antihistamine treatment. Patients were randomized to omalizumab 300 mg, 150 mg, 75 mg or placebo (1:1:1:1), given subcutaneously every four weeks for a total period of 24 weeks, and subsequently monitored during a 16 week follow-up period when there was no active treatment.

Novartis is committed to developing innovative, life-changing specialty dermatology therapies redefining treatment paradigms and transforming patient care in severe skin diseases where there are remaining high unmet medical needs. The Novartis specialty dermatology portfolio includes two unique targeted products in phase III development, omalizumab (Xolair) for CSU and secukinumab (AIN457) for moderate-to-severe plaque psoriasis. There are also more than 10 compounds in early stage development for a wide range of severe skin diseases in the Novartis specialty dermatology portfolio.

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