Ziarco Pharma Announces Positive Top Line Results from Phase 2a Study in Moderate to Severe Atopic Dermatitis with its Oral Lead Compound ZPL-389
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 resulted in a clinically and statistically significant decrease in inflammation compared to placebo. At week 8, ZPL-389 reduced EASI (Eczema Area and Severity Index) by 50% (placebo: 27%, (p=0.01)). In addition to EASI, there was also a statistically significant improvement on SCORAD (SCORing Atopic Dermatitis) and BSA (Body Surface Area). Furthermore, ZPL-389 showed a clinically meaningful improvement in various measures of pruritus (itching). Throughout the study, ZPL-389 was found to be well tolerated with a favourable safety profile comparable to placebo.
“These are spectacular results on the eczema scores and give promise for a safe and well tolerated product to be brought forward for patients where there is no currently approved oral, maintenance drug for this chronic inflammatory skin disease”; said Professor Thomas Werfel, Hannover Medical School, the Principal Investigator of the study.
The full data will be presented in a late-breaking oral abstract session at the European Academy of Allergy and Clinical Immunology (EAACI) Congress on 12 June 2016 in Vienna, Austria. Details are: New treatment modalities in atopic dermatitis, session number LB OAS 1: “A Phase 2a proof of concept clinical trial to evaluate ZPL-3893787 (ZPL-389) a potent, oral histamine H4 receptor antagonist for the treatment of moderate to severe atopic dermatitis (AD) in adults.”
Also commenting on the data, Mike Grey, Ziarco’s Executive Chairman, said: “These positive top line results demonstrate the significant potential of ZPL-389 as the first ever histamine H4 receptor antagonist for treating patients with moderate-to-severe atopic dermatitis (eczema). This is a major achievement for Ziarco and we now look forward to progressing the clinical development of our wholly-owned asset in a Phase 2b study later this year. I believe that an oral once daily therapy that is well tolerated and suitable for use by a wide range of patients, including the significant paediatric population, has great promise. These data provide further validation and support to the second Phase 2a clinical trial that is currently being run by Ziarco to determine the efficacy of ZPL-389 in moderate to severe psoriasis patients and we anticipate reporting top line results from that study in H1 2017.”
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.
For further information, please contact:
Ziarco Pharma Ltd Mike Grey / Arvind Hundal
arvind.hundal@ziarcopharma.com
Consilium Strategic Communications
Mary-Jane Elliott / Ivar Milligan
+44 (0)20 3709 5700
ziarco@consilium-comms.com
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.