Novartis Study Shows Omalizumab Effective In Severe Form Of Chronic Skin Disease

(RTTNews) - Novartis AG (NVS) Saturday announced new results from the Phase III ASTERIA I study showing omalizumab was effective and safe in the treatment of chronic spontaneous urticaria or CSU, a chronic and debilitating form of hives.

ASTERIA I is the final pivotal registration study for omalizumab in CSU to be announced. Results of the study were presented Saturday for the first time at the 22nd Congress of the European Association of Dermatology and Venereology or EADV in Istanbul, Turkey.

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

The study also showed patients treated with omalizumab 300 mg experienced nearly twice improvement in their quality of life as compared to those taking placebo by Week 12.

Additionally, by Week 12, more than half of omalizumab 300 mg patients had their CSU symptoms of itch and hives controlled and 36 percent had no symptoms at all.

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, known as angioedema.

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

The incidence and severity of adverse events was similar across all ASTERIA I treatment groups. Five omalizumab patients experienced serious adverse events during the treatment period, compared to four patients in the placebo group. No deaths were reported during this study.

Novartis said the ASTERIA I data support the positive and consistent results from two previously reported pivotal Phase III registration studies - ASTERIA II and GLACIAL - of omalizumab in CSU.

Omalizumab is currently not approved for the treatment of CSU. Regulatory applications for omalizumab in CSU were filed with US and EU health authorities in the third quarter.

Tim Wright, Global Head of Development, Novartis Pharmaceuticals, said, "The positive new data clearly show the potential of omalizumab to treat CSU, a disease where more than 50% of patients don't respond to approved doses of antihistamines, the only licensed treatment option."

Omalizumab is being jointly developed by Novartis and Genentech, Inc. for CSU.

The stock closed up 0.3 percent at 68.50 Swiss francs on Friday.