DISCOVERY PARK, Sandwich, United Kingdom--(BUSINESS WIRE)--Ziarco Pharma Ltd., a biopharmaceutical company focusing on the development of novel drugs against inflammatory skin disorders, today announced that dosing has started in a Phase 2a proof of concept study in moderate to severe psoriasis with ZPL-389. The Ziarco study commenced on schedule with results expected in H1 2017.
ZPL-389, a wholly-owned Ziarco drug, is a potent, selective histamine H4 receptor antagonist. The psoriasis Phase 2a clinical trial was opened under an IND at both US and European sites including the UK. It is a randomised, double blind, placebo controlled study in moderate to severe psoriasis patients. Subjects are being randomised to receive either oral 30 mg ZPL-389 once daily or placebo once daily for 12 weeks, with the primary endpoint of percentage change from baseline in the psoriasis area severity index (PASI) and secondary endpoint that includes improvement in the investigator’s global assessment (IGA). For more information about the study please visit https://clinicaltrials.gov/ct2/show/NCT02618616.
In addition, recruitment for a Phase 2a trial of ZPL-389 in moderate to severe atopic dermatitis has been completed and this will read out in Q2 2016.
Commenting on the start of dosing, Mike Grey, Executive Chairman of Ziarco, said: “We believe ZPL-389 has the potential to provide a first-in-class, safe and effective treatment for highly-prevalent, poorly-served inflammatory skin diseases. We are pleased to have initiated clinical Phase 2a studies with ZPL-389 in both atopic dermatitis and psoriasis and are anticipating the outcome of the atopic dermatitis study in the next few months.”
Dr. Dorota Wielowieyska-Szybińska, the study’s Principal Investigator, added: “Ziarco’s ZPL-389 is a new oral drug which has real potential to make a significant difference to the treatment of moderate to severe psoriasis patients. I am eager to see the study outcome as current oral treatments are often poorly tolerated and not indicated for long term use.”
US and EU5 estimates of psoriasis prevalence range from 2-4%. Plaque psoriasis accounts for approx. 90% of the psoriasis population. In the US, it is estimated that direct costs on health care approach ~$7B and the most severe patients (~10%) are typically treated with systemic biologics. Current treatments for the remaining 90% are suboptimal, both in terms of efficacy and safety.1
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, currently in two Phase 2a studies: the first in atopic dermatitis is fully recruited and will read out in Q2 2016; and the second has been initiated in moderate to severe psoriasis patients and is expected to be fully recruited in Q1 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 Q1 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.
1 Yeung et al. Psoriasis severity and the prevalence of major medical comorbidities: a population-based study. JAMA Dermatol. 2013 October 1; 149(10): 1173–1179