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news.UK-based biopharmaceutical firm Ziarco Group has dosed first patient in a Phase IIa proof-of-concept clinical trial of its once-daily, oral histamine H4 receptor antagonist, ZPL-389, in patients with moderate to severe atopic dermatitis.
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The trial, being carrying out at MAC Clinical Research in Manchester, UK, will evaluate the safety and efficacy of oral ZPL-389 in the treatment of inflammatory skin diseases, including atopic dermatitis and psoriasis.
Around 90 adults will be involved in this randomized, double blind, placebo controlled, parallel group Phase IIa trial.
Ziarco chief medical officer Pablo Jimenez said: "The initiation of this Phase IIa study is a key milestone in the development of ZPL-389 and the treatment of inflammation and pruritus.
"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 IIa trial’s primary endpoint is to measure the effects of eight weeks of treatment of an oral, once daily 30mg dose of ZPL-389 on pruritus, or itching, compared to placebo, while secondary endpoints include measurements of control of atopic dermatitis compared to placebo.