BOSTON, -- Surface Logix Inc. today announced the initiation of a Phase 2a clinical trial for SLx-2101 in patients with secondary Raynaud's disease. SLx-2101 is a novel, long-acting PDE-5 inhibitor being developed for the management of diseases associated with vascular dysfunction such as Raynaud's, a vasospastic disorder of small blood vessels leading to a marked reduction of blood flow to areas such as the fingers and toes. Often triggered by exposure to cold, Raynaud's is associated with painful blue or white digits, and in severe cases, may lead to the development of digital ulcers.
"PDE-5 inhibition holds promise in several cardiovascular indications, though many disorders such as Raynaud's are currently not addressed by marketed PDE-5 inhibitors," commented Paul Sweetnam, Ph.D., Chief Scientific Officer of Surface Logix. "We used our novel chemistry platform to design SLx-2101 to have a profile that would deliver fast onset and long duration of therapeutic effects in difficult-to-treat conditions such as Raynaud's, potentially enabling quicker, longer-lasting relief to patients."
"The initiation of this trial is part of Surface Logix's multiple indication development plan for SLx-2101. We believe that it has applicability in cardiovascular indications beyond erectile dysfunction and are therefore pursuing its advancement in specialized indications, such as Raynaud's, as well as in larger cardiovascular markets," said Jim Mahoney, President and Chief Executive Officer of Surface Logix.
The Phase 2a trial is a single European center, randomized, double-blind, placebo-controlled, crossover pilot study that will enroll 20 patients with secondary Raynaud's disease. The trial is designed to examine the safety, tolerability and pharmacodynamic profile of repeat oral doses of SLx-2101 once daily for up to 14 days. The primary objective of this trial is to investigate the severity of secondary Raynaud's disease-related attacks during the dosing period. Secondary objectives include evaluating the frequency and total daily duration of disease-related attacks during the dosing period, the safety and tolerability of SLx-2101, and the effect of the drug on capillary blood flow velocity and vasospastic symptoms.
Surface Logix also initiated a Phase 2a clinical trial to test the safety, tolerability and pharmacodynamics of orally administered SLx-2101 in patients with hypertension in June 2007. 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.
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.
Source: PR Newswire