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news.Synvista Therapeutics, a biopharmaceutical company, has received approval from the Israeli Ministry of Health to begin a Phase II trial of a topical formulation of SYI-2074 in mild-to-moderate plaque psoriasis.
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The trial is expected to begin enrollment in the fourth quarter of 2008 at three sites in Israel, and is designed to enroll a total of 30 patients in a randomized, placebo-controlled study. Top-line results are expected in the first quarter of 2009.
Previously, it has been reported that SYI-2074 blocks TNF-alpha activated expression of cell adhesion molecules, I-Cam and V-Cam, which may be essential for cellular migration. The TNF-alpha signaling pathway is an established target for drug development in psoriasis and other autoimmune diseases.
As a topical, SYI-2074 is not expected to have the side effects associated with systemic treatment using anti-TNF agents, the company said.
Noah Berkowitz, president and CEO of Synvista, said: “There have been successfully developed drugs that also interfere with TNF-alpha signaling, but these similar drugs are given as injections and are indicated for more severe forms of psoriasis. We believe that a topical drug will provide patients with an important alternative in the treatment of this disease.”