BOSTON, Jan. 8 /PRNewswire/ -- Surface Logix today announced positive results in the Company’s Phase 2a clinical trial of SLx-2101 in hypertension. The randomized, double-blind, placebo-controlled crossover Phase 2a study in 60 patients with uncontrolled hypertension demonstrated that SLx-2101 caused clinically significant reductions in blood pressure and was well tolerated. The trial was designed to examine the safety, tolerability and effect on blood pressure in patients of repeat oral doses of SLx-2101 once daily for up to 14 days.
“These data confirm the promise of efficacy seen in earlier clinical trials, and we plan to initiate a Phase 2b study of SLx-2101 in hypertension in the third quarter of 2008,” said Jim Mahoney, President and CEO of Surface Logix. “We believe that with our demonstrated 24-hour coverage from once daily dosing and excellent tolerability profile, we will be able to uniquely position SLx-2101 in several segments of the hypertension market.”
SLx-2101 is an oral, potent, selective, fast-onset, long-acting PDE5 inhibitor. Other PDE5 inhibitors have traditionally been used to treat erectile dysfunction (ED). SLx-2101 was designed specifically to expand the therapeutic potential of PDE5 inhibition beyond ED into larger cardiovascular markets such as hypertension. SLx-2101 is uniquely positioned among the known PDE5 inhibitors to address cardiovascular disease because, compared to currently marketed PDE5 drugs, SLx-2101 preferentially distributes into cardiovascular tissue. With its large volume of distribution, SLx-2101 achieves sustained plasma levels and a long duration of action, without showing accumulation upon repeat dosing. This allows for daily or on demand dosing with a predictable response in a number of cardiovascular disorders that currently marketed PDE5 therapies cannot adequately address.
“To achieve efficacy in cardiovascular disease, your compound has to get into the right tissues,” commented Dr. Paul Sweetnam, Chief Scientific Officer at Surface Logix. “By leveraging our deep understanding of how small molecules interact with a variety of lipids and proteins, we succeeded in creating a drug candidate that is able to access PDE5 in cardiovascular tissue in a physiologically meaningful way. These Phase 2a clinical results of SLx-2101 demonstrate the translation of this property into therapeutic activity in hypertensive patients, a first for a PDE5 inhibitor.”
The results from the trial provide further confirmation for the Pharmacomer(TM) Technology Platform designed by Surface Logix scientists to engineer specific PK and tissue distribution properties into a molecule while optimizing potency and selectivity. The design of SLx-2101 and its development program were directed to differentiate SLx-2101 from other PDE5 inhibitors based on the combined features of potency and an extended duration of action.
About the trial:
The Phase 2a study of SLx-2101 was a randomized, double-blind, placebo-controlled crossover trial, and was conducted at two centers in Europe. A total of 60 patients with uncontrolled hypertension, who were concurrently taking up to 3 marketed anti-hypertensive medications, received 5 mg or 10 mg oral doses of SLx-2101 once daily for up to 14 days. In addition to showing the safety and tolerability of the compound in these dosing regimens, blood pressure monitoring using standard measures (office seated & standing, central, home, and ambulatory) demonstrated that SLx-2101 caused clinically significant reductions in blood pressure.
About SLx-2101
SLx-2101 is an oral, potent, selective, fast-onset, long-acting PDE5 inhibitor designed specifically to expand the therapeutic potential of PDE5 inhibition beyond erectile dysfunction into larger cardiovascular markets such as hypertension. Clinical experience with SLx-2101 to date, including in ED, confirms its ability to positively impact endothelial function in a wide range of tissues. SLx-2101 is uniquely positioned among the known PDE5 inhibitors to address cardiovascular disease because, compared to currently marketed PDE5 drugs, SLx-2101 preferentially distributes into cardiovascular tissue. By virtue of its large volume of distribution, SLx-2101 achieves sustained plasma levels and a long duration of action, without showing accumulation upon repeat dosing. This superior product profile allows for daily or on demand dosing with a predictable response in a number of cardiovascular disorders that currently marketed PDE5 therapies cannot adequately address. Surface Logix is also currently conducting a Phase 2a study of SLx-2101 in secondary Raynaud’s disease, a vasospastic condition in which PDE5 inhibition has been shown to have a therapeutic benefit. Preclinical data obtained in models of heart failure suggest that SLx-2101 has potential in this indication as well.
About Surface Logix, Inc.
Surface Logix, Inc. uses its expertise in biophysical chemistry to create and develop novel small molecule drugs (NCEs) with superior drug-like properties that are clearly differentiated from competitive products. The company is advancing multiple internal programs focused primarily on cardiovascular, metabolic, oncologic and fibrotic diseases. For more information, please visit http://www.surfacelogix.com.
scavanaugh@macbiocom.com
CONTACT: Leland Webster, Ph.D., M.B.A., Vice President, Corporate
Development, of Surface Logix, Inc., +1-617-746-8520; or Media, Sarah
Cavanaugh, of MacDougall Biomedical Communications Inc., +1-781-235-3060,
scavanaugh@macbiocom.com, for Surface Logix, Inc.
Web site: http://www.surfacelogix.com/
