TEL AVIV, Israel and SAN DIEGO, May 21, 2012 – VBL Therapeutics, a clinical stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced data demonstrating VB-201 was found to be effective in attenuating inflammatory bowel disease (IBD) in preclinical models. VB-201 is a first-in-class, orally available disease-modifying agent selected from a series of proprietary oxidized phospholipid analogs pioneered by VBL in the Lecinoxoid molecular class. The results were presented today during a poster presentation at Digestive Disease Week (DDW) 2012 by Eyal Breitbart, Ph.D., vice president of research at VBL.
IBD is a chronic relapsing inflammatory disorder of the gastrointestinal tract that affects millions of people worldwide. The two most common forms of IBD are Crohn’s disease, which can affect any part of the gastrointestinal tract, and ulcerative colitis, which is restricted to the colon and/or rectum. Evidence suggests that Th1 and Th17 inflammatory cytokines found in the intestinal mucosa are implicated in colitis pathogenesis.1 Recent studies have indicated that oxidized phospholipids can down-regulate the production of pro-inflammatory cytokines.
“There is a significant need for orally available, non-systemic, disease-modifying treatments for the control of chronic inflammatory diseases such as IBD,” said Dr. Breitbart. “These preclinical study findings show that VB-201 possesses anti-inflammatory properties and can effectively reduce the severity of IBD in multiple experimental mouse models. The data are extremely promising and add to the recent positive results from a Phase 2 sub-study of VB-201 in psoriasis patients with atherosclerosis. We look forward to advancing VB-201 into human clinical trials for IBD.”
The study evaluated the efficacy of VB-201 in three mouse models of IBD: trinitrobenzene sulfonic acid (TNBS)-induced colitis, T cell-induced colitis and dextran sulfate sodium (DSS)-induced colitis. The data findings demonstrated that treatment with VB-201 alleviated wasting disease in all three disease models. Additionally, VB-201 restrained gastrointestinal inflammation across models, with efficacy comparable to commonly used potent positive controls.
Current immune-inflammatory treatments are mainly non-oral drugs and while efficacious, they do not successfully treat all patients and can cause significant side effects, making them unsuitable for the patient population affected by mild to moderate forms of the disease. VB-201 has a mechanism of action that works in a targeted, localized way to modulate the immune system, potentially resulting in better patient outcomes with fewer side effects.
VB-201 is a proprietary, first-in-class, orally-available, specific innate immunity disease-modifying medicine in development for the effective treatment of chronic immune-inflammatory diseases. VB-201 offers the potential to deliver long-term control of a spectrum of immune-inflammatory conditions, including psoriasis, rheumatoid arthritis, atherosclerosis and inflammatory bowel disease.
Five Phase 1 clinical trials involving 140 healthy subjects have demonstrated that VB-201 is well tolerated with a favorable safety profile. VBL recently completed a Phase 2 clinical trial for VB-201 in patients with moderate to severe psoriasis. Data from a Phase 2 sub-study of VB-201in psoriasis patients with cardiovascular risk demonstrated a statistically significant reduction in vascular inflammation associated with atherosclerotic lesions as measured by PET-CT imaging. The findings validate the compound’s novel mechanism of action for the control and attenuation of chronic immune-inflammatory diseases via highly selective modulation of components of the innate immune system, and demonstrate an anti-inflammatory effect on two systemic inflammatory conditions simultaneously—atherosclerosis of the vascular wall and psoriasis.