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news.Resolvyx Pharmaceuticals, a resolvin therapeutics company, has initiated the first human clinical trial evaluating a resolvin therapeutic, RX-10045, in a Phase I/II clinical trial in patients with moderate-severe dry eye syndrome.
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The randomized, multi-center, placebo-controlled, dose-ranging study is designed to evaluate the safety, tolerability and efficacy of RX-10045 in improving the signs and symptoms of dry eye.
Approximately 200 patients will be enrolled in the trial which will evaluate the effects of RX-10045 on multiple endpoints recognized by the FDA: objective measures of corneal and conjunctival staining, tear film break-up time, as well as subjective measures of discomfort.
RX-10045 is a synthetic analog of RvE1, a naturally occurring resolvin with potent anti-inflammatory and cell-sparing activities in laboratory testing.
Paul Rubin, CEO of Resolvyx, said: “This is an important milestone for Resolvyx, as initiation of this trial offers the first opportunity to demonstrate the clinical importance of resolvins as a new class of therapeutics. We are delighted to have successfully initiated this study, and anticipate receiving data in the first half of 2009.”