• 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, UK I June 13, 2016 I 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.

The full data were presented for the first time yesterday by the Principal Investigator, Professor Thomas Werfel Hannover Medical School, Germany in a late breaking oral abstract session at the European Academy of Allergy and Clinical Immunology 35th Annual Congress 2016 in Vienna, Austria.

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.

Throughout the study, ZPL-389 was found to be well tolerated with a favourable safety profile comparable to placebo.

Commenting on the study, Professor Thomas Werfel, said: “The effect of ZPL-389 on inflammation is significant and the effect does not seem to have plateaued after eight weeks of treatment. In addition, the various improvements in pruritus seen with ZPL-389 vs placebo are extremely encouraging. I am looking forward to seeing the outcome of the longer 12-week Phase 2b trial that is planned to start later this year. The impact of atopic dermatitis on patients’ lives is significantly debilitating and this drug could be transformational.”

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:

Presentation: www.youtube.com/watch?v=jJJa2O6nmTA

Summary: www.youtube.com/watch?v=7XDw-fu8fn0

About Ziarco

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 www.ziarcopharma.com.

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 www.innovateuk.org.

SOURCE: Ziarco