VBL Therapeutics' VB-201 drug has met the primary endpoint in a Phase 2 study, demonstrating a considerable reduction in vascular inflammation associated with atherosclerotic lesions in patients with moderate to severe psoriasis.
VB-201 is a first-in-class, orally-available, specific innate immunity disease-modifying medicine, in development for the treatment of chronic immuno-inflammatory diseases.
The Phase 2 double-blind randomised dose-ranging placebo-controlled trial involved around 185 patients who received either 20mg or 80mg of VB-201 or placebo once-daily for 12 weeks.
In the overall Phase 2 study, VB-201 showed a safety and tolerability profile with improvements in the psoriasis efficacy endpoints, Physician Global Assessment and Patient Global Assessment.
VBL Therapeutics clinical development vice president Yael Cohen said the data suggested that VB-201 showed control over primary chronic immuno-inflammatory disease as well as the reduction of the elevated cardiovascular risk accompanying the primary disease.
"It's encouraging to see the psoriasis efficacy measures did not plateau at the conclusion of the 12-week trial and, as a result, an additional trial with higher dosage and longer duration is underway," Cohen added.
In the pre-defined cardiovascular sub-study, VB-201 generated dose-responsive mean reduction of 12.7% of the inflammation associated with vascular endothelial lesions over the 12-week dosing period.
Massachusetts General Hospital Massachusetts General Physicians Organization vice president and principal investigator of the study Alexa Boer Kimball said the Phase 2 data is promising and demonstrates an anti-inflammatory effect of VB-201 on psoriasis patients with atherosclerosis within a short time period.
"These data are especially important given the growing evidence linking cardiovascular events and elevated mortality in patients with chronic inflammation, including patients with psoriasis," Kimball added.
"This study serves as a proof of concept for this compound's novel mechanism of action and demonstrates an anti-inflammatory effect on two systemic inflammatory conditions simultaneously; atherosclerosis of the vascular wall and psoriasis."