Surface Logix Commences Phase 2A Clinical Trial Of SLx-2101 In Hypertension

Main Category: Hypertension
Also Included In: Clinical Trials / Drug Trials
Article Date: 20 Jun 2007 - 0:00 PST

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Surface Logix Inc. today announced the initiation of a Phase 2a clinical trial to test the safety, tolerability and pharmacodynamics of orally administered SLx-2101 in patients with hypertension. SLx-2101 is a novel, long-acting PDE-5 inhibitor that was designed to deliver efficacy in a range of cardiovascular diseases, which were originally viewed as obvious therapeutic targets for PDE-5 inhibition, including hypertension.

"SLx-2101 was designed to have a profile that would deliver efficacy in cardiovascular indications where other PDE-5 inhibitors have failed," said Paul Sweetnam, Ph.D., Chief Scientific Officer of Surface Logix. "The performance of SLx-2101 in preclinical and early clinical studies has differentiated it from previous PDE-5 inhibitors. For example, we confirmed activity 48 hours after a single dose of 10mg, making SLx-2101 the first PDE-5 inhibitor to demonstrate such prolonged duration of activity using an objective measure."

"The early clinical studies have established SLx-2101 as an active once- daily and well tolerated inhibitor of PDE-5," stated William Prince, Ph.D., MB, ChB, FFPM, Chief Development Officer of Surface Logix. "The activity of SLx-2101 on endothelial function and blood pressure combined with once-daily dosing has driven our decision to start clinical development in hypertension. We look forward to further exploring SLx-2101 in indications like hypertension that address large markets not currently addressed by marketed PDE-5 therapies."

The pilot Phase 2a trial is a randomized, double-blind, placebo-controlled crossover study being conducted at two centers in Europe. The trial is expected to enroll 40 patients who will receive 5mg or 10mg oral doses of SLx- 2101 once daily for up to 14 days. The study objectives are to determine the effect of SLx-2101 on placebo-corrected, office-seated peripheral systolic and diastolic blood pressure, as well as on home monitored blood pressure.

Interim data from a Phase 2a study of SLx-2101 in erectile function confirmed its activity 48 hours after a single dose of 10mg, making it the first PDE-5 inhibitor to confirm such prolonged duration of activity using an objective measure. Previous Phase 1 studies of SLx-2101 in healthy male volunteers demonstrated its favorable safety, tolerability, pharmacokinetics and pharmacodynamic activity. Additionally, in preclinical animal models, the candidate was highly potent and selective, induced rapid cellular and tissue response and provided an extended duration of action.

About SLx-2101

SLx-2101 is an oral, potent, selective, fast-onset, long-acting (48 hour) PDE-5 inhibitor designed specifically to expand the therapeutic potential of PDE-5 inhibition beyond erectile dysfunction into larger cardiovascular (CV) markets. SLx-2101 was designed using Surface Logix's proprietary chemistry platform, the Pharmacomer Technology Platform, to have a combination of potency, selectivity, tissue distribution and half-life, which optimizes its potential for once-daily utility in the vascular tissues involved in major cardiovascular diseases. The clinical experience of SLx-2101 to date establishes the PK range of the PDE-5 inhibitor, as well as demonstrates efficacy in established models of endothelial function (peripheral arterial tone and erectile function).

About Surface Logix Inc.

Surface Logix Inc. uses its expertise in biophysical chemistry to create new small molecule drugs that are optimized to meet the challenges of human physiology. The company is advancing multiple internal programs focused primarily on cardiovascular, metabolic, inflammatory and fibrotic diseases. For more information, please visit http://www.surfacelogix.com.

Surface Logix Inc.
http://www.surfacelogix.com

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