- Acquisition to add a once-daily oral H4 receptor antagonist, ZPL389, to treat atopic dermatitis, commonly known as eczema, to the Novartis industry-leading pipeline
- Investigational ZPL389 showed a clinically and statistically significant improvement of eczema lesions, leading to a 50% reduction in EASI score compared to placebo after eight weeks of treatment with a favorable safety profile
- Eczema is a chronic, inflammatory skin condition affecting millions of children and adults worldwide with an unmet need for effective and safe oral treatments
- Novartis announced today that it has entered into a definitive agreement for the acquisition of Ziarco Group Limited, a privately held company focused on the development of novel treatments in dermatology. This acquisition would add a once-daily oral H4 receptor antagonist in development for atopic dermatitis (AD), commonly known as eczema, to complement the growing Novartis dermatology portfolio and pipeline. The transaction is subject to customary closing conditions, including regulatory approval. The financial details of this transaction are not disclosed.
Ziarco’s lead investigational product, ZPL389, is a potential first-in-class oral treatment for moderate-to-severe eczema. Eczema is a chronic, itchy, inflammatory skin condition found in millions of children and adults worldwide. In addition, it is associated with sleep loss and a significant reduction in quality of life. Currently, no safe, effective, and well-tolerated oral treatments are available for the moderate-to-severe form of this condition.
"There is an unmet need for innovative, effective and safe oral treatment options for people living with eczema," said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "We are proud of our dermatology capabilities shown by the recent successful launches of Cosentyx and Xolair. Now we’re excited about a potential new medicine for people with eczema through the acquisition of Ziarco and the addition of a first-in-class oral H4 receptor antagonist to our growing pipeline."
In a proof of concept study, ZPL389 showed a clinically and statistically significant reduction of eczema. After eight weeks of treatment, the compound reduced the Eczema Area and Severity Index (EASI) score by 50% (placebo: 27%, (p=0.01)) in a study of 98 patients. In addition, there was a statistically significant improvement in SCORing Atopic Dermatitis (SCORAD) and body surface area (BSA) scores affected by eczema for ZPL389. The study also showed a decrease in itching, which was numerically greater in the active treatment arm. Both the EASI and SCORAD sub-scores related to itching showed positive results and there was a statistically significant decrease in sleep loss for the active comparator. Itch is a major cause for sleep loss in eczema patients. In clinical studies conducted to date, ZPL389 has a favorable safety profile.
Eczema poses a significant burden on health-care resources and patients’ quality of life with recent data showing that its prevalence is still increasing. Eczema affects up to 10% of the population in the US alone , , with approximately 15% of children and 70% of adults having the moderate-to-severe form of the disease. Treatment does not cure eczema but can control symptoms and potentially improve quality of life.
About the Novartis dermatology portfolio
Novartis is committed to addressing the unmet medical needs of patients living with dermatological conditions and improving their overall quality of life by providing innovative medicines. The Novartis Dermatology portfolio includes Cosentyx (secukinumab) for the treatment of moderate-to-severe psoriasis and Xolair (omalizumab) for the treatment of chronic spontaneous urticaria.