The initiation of this Phase 2a study is a key milestone in the development of ZPL-389 and the treatment of inflammation and pruritus,” said Pablo Jimenez, M.D., Chief Medical Officer of Ziarco. “Our oral H4 receptor antagonist has the potential to improve the quality of life for patients with inflammatory skin conditions such as atopic dermatitis by providing them with a safe, effective and convenient treatment. Data from this trial are expected to be presented in the second quarter of 2016. In addition, we look forward to initiating a clinical trial of ZPL-389 in patients with psoriasis in early 2016.”
The Phase 2a clinical trial is a randomized, double blind, placebo controlled, parallel group study to determine the safety and efficacy of oral ZPL-389 in 90 adults with moderate to severe atopic dermatitis. The primary endpoint is to measure the effects of eight weeks of treatment of an oral, once daily 30 mg dose of ZPL-389 on pruritus, or itching, compared to placebo. Secondary endpoints include measurements of control of atopic dermatitis compared to placebo. Quality of life measures will also be analyzed.
Atopic dermatitis is a chronic inflammatory skin disease characterized by impaired skin integrity, inflammation, extensive pruritus and a clinical course defined by symptomatic flares and remissions. The disease occurs in all races and geographic locations, with adult patients presenting a chronic and recurrent course of the disease. The highest incidence of the condition is in urban and developed areas. Visible skin lesions affect social interactions, psychological adjustment, career success, and overall quality of life. Mood disturbances such as anxiety, depression, mood changes, self-esteem, or stigmatization are prevalent in adult patients.
“I am excited to take part in this trial, and evaluate a potential new therapy for atopic dermatitis,” commented Professor Thomas Werfel, Principal Investigator of the study and Deputy Director of the Department of Dermatology, Allergology and Venereology at Hannover Medical School in Germany. “While older treatments exist, there remains a significant need for new therapies, especially oral treatments that are safe for long-term use and address all aspects of the disease, including itch.”
Ziarco was the recipient of funding from UK’s innovation agency, Innovate UK, which has been used to partly fund the Phase 2a study together with funding from existing investors.
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.
Ziarco is a clinical-stage biotechnology company developing innovative therapeutics targeting inflammatory skin diseases. The company’s lead compounds are ZPL-389, an oral histamine H4 receptor antagonist being studied for atopic dermatitis, and ZPL-521, a cPLA2 inhibitor being studied for inflammatory skin disease. Ziarco 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.
Further information can be found at www.ziarcopharma.com.