Article posted: Jun 13, 2016
Ziarco reports positive Phase 2a study results with ZPL-389 in moderate to severe atopic dermatitis patients
- Clinically and statistically significant reduction in signs and symptoms of moderate to severe atopic dermatitis
- 50% (p=0.01) improvement on the eczema severity score (EASI) at week 8
- ZPL-389 was well tolerated with a safety profile comparable to placebo
- Phase 2b study to commence in H2 2016
- Full study data presented at European Academy of Allergy and Clinical Immunology 35th Annual Congress 2016 Vienna, Austria on 12 June
Discovery Park, Sandwich, UK, 13 June, 2016 - Ziarco Pharma Ltd., a biopharmaceutical company focusing on the development of novel drugs for the treatment of inflammatory skin disorders, today announces positive, full results from its first Phase 2a proof of concept study with ZPL-389 in adults. The study demonstrated evidence of efficacy and safety of ZPL-389, a potent once daily oral histamine H4 receptor antagonist for the treatment of moderate to severe atopic dermatitis, a chronic skin disease with no safe, effective, and well tolerated oral treatments available.
In the European multi-country study, 98 subjects with moderate to severe atopic dermatitis (the most common form of eczema) were randomised 2:1 to receive orally either 30 mg ZPL-389 or placebo once daily for eight weeks, respectively.
ZPL-389 showed a clinically and statistically significant reduction in signs and symptoms of moderate to severe atopic dermatitis. At week eight, ZPL-389 reduced EASI (Eczema Area and Severity Index) by 50% (placebo: 27%, (p=0.01)). In addition, there was also a statistically significant improvement on SCORAD (SCORing Atopic Dermatitis), with ZPL-389 reducing SCORAD by 43% compared to 26% for placebo (p=0.004). Participants in the study had, on average, 44% of their body surface area (BSA) affected by atopic dermatitis and in those treated with ZPL-389 BSA was reduced by 18% compared to 12% for placebo (p = 0.04).
ZPL-389 also showed a clinically meaningful improvement in pruritus (itching) and NRS (a 0-10 numerical rating scale completed by the patients) was reduced by 3 points (~42%) compared to ~37% for placebo (not statistically significant). Both the EASI and SCORAD sub-scores associated with pruritus showed improvement and there was also a statistically significant decrease in sleep loss in the ZPL-389 treatment arm.
Mike Grey, Ziarco’s Executive Chairman, added: "There is a real need for a safe and effective drug that can be given orally to treat moderate to severe atopic dermatitis patients and that is the profile we are seeing for ZPL-389. These data have demonstrated a significant effect on inflammation. Our Phase 2b study, with EASI as the primary end point, will run for 12 weeks to explore the additional benefit that could be gained from longer dosing of ZPL-389.”
Ziarco was the recipient of funding from UK’s innovation agency, Innovate UK, which has been used to partly fund the Phase 2a atopic dermatitis study.
Videos of Professor Werfel presenting the data and a summary can be viewed here:
For further information, please contact:
Ziarco Pharma Ltd
Mike Grey / Arvind Hundal email@example.com
Consilium Strategic Communications
Mary-Jane Elliott / Ivar Milligan
+44 (0)20 3709 5700
Ziarco is a clinical-stage biotechnology company developing innovative therapeutics targeting dermatological and inflammatory diseases. ZPL-389, the Company’s lead compound, is an oral histamine H4 receptor antagonist. Ziarco has successfully completed a Phase 2a study in atopic dermatitis and a Phase 2a study in psoriasis is ongoing with data expected in H1 2017. ZPL-521, a topical cPLA2 inhibitor, is being developed for moderate to severe inflammatory skin diseases and is targeted to start a clinical study in atopic dermatitis in mid- 2016, with data due in H1 2017. Ziarco’s investors include Biotechnology Value Fund L.P. and other affiliates of BVF Partners L.P., Pfizer Venture Investments, New Enterprise Associates, Lundbeckfond Ventures and Amgen Ventures. Founded in October 2012, the Company is based in Discovery Park, Sandwich, UK. For more information please visit
About Atopic Dermatitis (Eczema)
Atopic dermatitis, also known as atopic eczema, is a chronic debilitating inflammatory skin disease that affects both adults and children. Global estimates of atopic dermatitis prevalence are significant and reportedly increasing, with a child prevalence of 10 - 20% and adult prevalence up to 3%. In the US alone it is estimated that there are 32 million adults and children with eczema, of which about 18 million have moderate to severe eczema or atopic dermatitis.
About Innovate UK
Formerly known as the Technology Strategy Board, Innovate UK is the UK’s innovation agency. Its goal is to accelerate economic growth by stimulating and supporting business-led innovation. Sponsored by the Department for Business, Innovation and Skills (BIS), Innovate UK brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy. For more information, please visit