Synvista Therapeutics Announces First Dosing of SYI-2074 in Clinical Trial for Psoriasis
MONTVALE, N.J., Dec. 15 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. has dosed the first patient in a 30-patient Phase 2 clinical trial of its proprietary topical GPx-mimetic, SYI-2074, in patients with psoriasis. The trial is planned to be a 28-day multi-center, randomized, double-blind, placebo controlled study to assess the efficacy of topical SYI-2074, applied twice daily, for the treatment of chronic, mild-to-moderate plaque psoriasis in adults. The trial is being conducted in three centers in Israel.
"We are very excited to begin phase 2 clinical trials on SYI-2074 for psoriasis," said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista Therapeutics. "We believe that there is immense potential to expand the scope of treatment modalities for psoriasis following this trial and look forward to reporting results in the first quarter of 2009."
About SYI-2074
Synvista's GPx mimetic program is based on the rational design of oral and topical drugs that mimic the activity of glutathione peroxidase (GPx), the only enzyme in the human body that reduces oxidized lipids.
GPx is a well validated target for drug development. Animal models have shown that elevated activity of GPx protects animals from experiencing heart attacks and atherosclerosis and reduced levels of GPx put them at risk for those diseases or complications. In humans, research suggests the risk of cardiovascular disease varies inversely with levels of GPx activity (i.e., higher levels of oxidized lipids promote the creation of oxygen free radicals and reactive oxygen species (ROS), such as H2O2, which can promote inflammation).
As noted above, a topical form of our GPx mimetic SYI-2074 is being developed for treatment of mild to moderate plaque psoriasis, an inflammatory disease highly correlated with a molecular signaling pathway that can be inhibited by SYI-2074.
About Psoriasis
Psoriasis is an immune-mediated chronic inflammatory disease usually characterized by red lesions or silvery white scales on the skin, which usually occur on the scalp, knees, elbows, the abdomen (around the navel) and the genitals. In about a quarter of the cases, psoriasis can lead to psoriatic arthritis, another inflammatory disease affecting the joints.
While the exact cause of the disease is unknown, it is believed that both genetic and hormonal factors play a role. It is also known that the TNF-alpha pathway plays a role in the progression of the disease. Other companies have 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 the disease. Synvista intends to differentiate SYI-2074 by developing a topical formulation of the drug for the treatment of mild-to-moderate psoriasis.
About Synvista Therapeutics
Synvista Therapeutics is a biopharmaceutical company developing diagnostics and drugs to diagnose, treat and prevent cardiovascular disease in people with diabetes. The Company has developed a clinical laboratory test that identifies diabetic patients with the Haptoglobin genotype Hp2-2. The genetic or protein form of this test can be used to identify diabetic patients at high risk for cardiovascular complications. These patients may benefit from a particular formulation of vitamin E. The Company is also developing a test kit to measure CML (carboxy-methyllysine), another potential cardiovascular risk marker.
Synvista Therapeutics is developing oral antioxidant drugs to treat the HDL dysfunction seen in Hp2-2 diabetes, a disease affecting almost 7 million patients in the United States. The Company is also developing alagebrium, a proposed breaker of advanced glycation endproducts (AGEs) for the treatment of systolic and diastolic heart failure.
For more information, please visit the Company's Web site at www.synvista.com.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties including, but not limited to, the Company's ability to obtain sufficient financial resources to continue operations, the risks associated with the events described in this press release, future clinical development of Synvista Therapeutics' product candidates, and other risks identified in Synvista Therapeutics' filings with the Securities and Exchange Commission. Further information on risks faced by Synvista are detailed under the caption "Risk Factors" in Synvista Therapeutics' Annual Report on Form 10-K for the year ended December 31, 2007. These filings are available on a website maintained by the Securities and Exchange Commission at http://www.sec.gov. The information contained in this press release is accurate as of the date indicated. Actual results, events or performance may differ materially. Synvista Therapeutics undertakes no obligation to publicly release the result of any revision to these forward- looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
CONTACT: Synvista Therapeutics, Inc., +1-201-934-5000, ir@synvista.com; or
Kim Sutton Golodetz - Investors, kgolodetz@lhai.com, or Jules Abraham -
Media, jabraham@lhai.com, +1-212-838-3777, both of Lippert/Heilshorn &
Associates
Web site: htpp://www.synvista.com/