VBL Therapeutics, a clinical stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced that a Phase 2 sub-study of VB-201 in moderate to severe psoriasis patients with cardiovascular risk has successfully achieved its primary endpoint demonstrating a statistically significant reduction in vascular inflammation associated with atherosclerotic lesions as measured by PET-CT imaging. VB-201 is a first-in-class, oral disease-modifying agent selected from a series of proprietary oxidized phospholipid analogs pioneered by the company in the Lecinoxoid molecular class. The compound is being developed as an oral controller medicine for chronic immuno-inflammatory disease and atherosclerosis inflammation.
The results were presented today at 4:00 p.m. P.S.T during the Late-Breaking Research Symposium at the American Academy of Dermatology 70th Annual Meeting in San Diego. The oral presentation titled "Safety and Efficacy of VB-201, a Novel Immune-modulator, on Inflammation of Atherosclerotic Disease in Patients with Moderate to Severe Plaque Psoriasis: A Phase 2 Randomized Placebo Controlled Trial" was given by Alexa Boer Kimball, M.D., M.P.H., vice chair, department of dermatology; director, clinical unit for research trials in skin; vice president, Massachusetts General Physicians Organization at Massachusetts General Hospital; and principal investigator of the study.
The findings validate the compound's novel mechanism of action for the control and attenuation of chronic immuno-inflammatory diseases via the highly selective modulation of components of the innate immune system. Central to the overall mechanism of action for VB-201 are the targeted antagonism of cell-surface Toll-Like Receptor (TLR)-2 and TLR-4 co-receptor CD-14, and the inhibition of chemokine-mediated migration of monocytes to inflamed tissue. The study data support the growing scientific evidence that these mechanisms are important in regulating inflammation in atherosclerosis. VB-201 is a first-in-class, specific, orally-available innate immunity controller drug.
"The Phase 2 data are promising and demonstrate an anti-inflammatory effect of VB-201 on psoriasis patients with atherosclerosis within a short time period," said Dr. Kimball. "VB-201 is the first drug we aware of to demonstrate a reduction in the inflammation associated with atherosclerosis through this pathway. These data are especially important given the growing evidence linking cardiovascular events and elevated mortality in patients with chronic inflammation, including patients with psoriasis. 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."
In the pre-defined cardiovascular sub-study, PET-CT scans were used to evaluate the effect of VB-201 on the suppression of active inflammation in atherosclerotic lesions. PET-CT has been validated as an imaging tool for measuring vascular inflammation related to atherosclerosis and has been shown to predict cardiovascular events. VB-201 produced a statistically significant, dose-responsive mean reduction of 12.7 percent of the inflammation associated with vascular endothelial lesions (80 mg dose group)
In the overall Phase 2 study, VB-201 demonstrated an excellent safety and tolerability profile. There were no treatment-related serious adverse events observed, and the overall rates of adverse events were similar across the VB-201 drug and placebo dosing arms. Statistically significant improvements in the psoriasis efficacy endpoints, Physician Global Assessment and Patient Global Assessment.
"We are excited to reveal that the favorable experimental data in the atherosclerosis models has translated into proof of concept in humans," said Yael Cohen, M.D., vice president, clinical development at VBL. "We believe that these data suggest that VB-201 is an excellent candidate for both the control of 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."