Phase 2 study of VB-201 for the treatment of chronic inflammatory diseases

VBL Therapeutics announced the initiation of a Phase 2 study to evaluate the efficacy and safety of its lead compound, VB-201, among patients with elevated high sensitivity C-reactive protein (hsCRP) who are currently taking statins. The double-blind, randomized, placebo-controlled, multi-site, dose-ranging study will enroll 320 patients, ≥18 years of age who have elevated hsCRP levels and have been taking statins for at least 3 months. Patients will receive one of several doses of VB-201 or a placebo orally once daily for 4 weeks. The study will examine the effect of VB-201 on hsCRP and other inflammatory biomarker levels at a broad range of doses, allowing researchers to evaluate the relationship between dose and anti-inflammatory response.

VB-201, the lead candidate in a novel family of anti-inflammatory compounds called Lecinoxoids, has strong potential as a specific, targeted oral controller medication for inflammatory diseases. VB-201 has a cellular mechanism of action that works in a targeted, localized way to modulate the immune system. Preclinical and Phase 1 studies have suggested that VB-201 has potential utility across multiple, chronic inflammatory diseases, including psoriasis, rheumatoid arthritis and atherosclerosis.

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