Date: 2015-02-17
Type of
information: Results
phase: 2
Announcement: results
Company: VBL Therapeutics (Israel)
Product: VB-201
Action
mechanism:
- lecinoxoid. 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 is a lecinoxoids compound, these compounds are structurally and functionally similar to naturally occurring molecules, known as oxidized phospholipids, which possess immune modulating anti-inflammatory properties, modified to enhance stability and activity. Lecinoxoids mimic the structure of oxidize phospholipid molecules and are synthetically manipulated to increase their stability and ability to target specific receptors. Lecinoxoids have the potential to act on two specific mechanisms: the inhibition of cellular signaling cascades associated with the innate immune system, known as toll-like receptor, or TLR, signaling, and the inhibition of the migration of monocytes toward chemo attractants present in areas of inflammation.
Disease: ulcerative colitis
Therapeutic
area: Autoimmunes diseases - Inflammatory diseases
Country: Bulgaria, Hungary, Poland
Trial
details:
- The Phase 2 clinical study in patients with ulcerative colitis is a randomized, double-blind, placebo-controlled trial with 24 weeks of daily oral administration of 160mg (80mg BID) VB-201. This trial is being conducted at centers in Poland, Bulgaria and Hungary, with central endocopic evaluation by BioClinica Inc. in Newtown, PA, USA. (NCT01839214)
Latest
news:
- • On February 17, 2015, VBL Therapeutics announced that its Phase 2 studies evaluating lead Lecinoxoid compound VB-201 in patients with psoriasis and ulcerative colitis did not meet their primary endpoints. The company does not plan to continue development of VB-201 in these indications. The Phase 2 randomized, double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of VB-201 dosed at 160 mg daily for 24 weeks. The study evaluated 112 patients with mild to moderate ulcerative colitis. The primary endpoint of the study was disease remission at weeks 12 and 24. No statistically significant effect of VB-201 was observed compared to placebo on the primary or secondary endpoints. Remission rate for VB-201 was 10.5% at 12 weeks and 22.8% at 24 weeks, a meaningful improvement over week 12 (p=0.02). However, remission rate for the placebo arm was 15.1% at 12 weeks. The 7.7% difference of VB-201 over placebo was not statistically significant. VB-201 was safe and well-tolerated. There were no drug-related serious adverse events.
- • On June 20, 2014, VBL Therapeutics announced that it has completed enrollment of two Phase 2 studies evaluating the efficacy of lead Lecinoxoid compound VB-201 in psoriasis and ulcerative colitis. A total of 194 patients with psoriasis and of 112 patients with ulcerative colitis were enrolled in the study. The Company expects to report top line results from each of the studies in the first quarter of 2015. The Phase 2 clinical study in patients with ulcerative colitis is a randomized, double-blind, placebo-controlled trial with 24 weeks of daily oral administration of 160mg (80mg BID) VB-201. This trial is being conducted at centers in Poland, Bulgaria and Hungary, with central endocopic evaluation by BioClinica Inc. in Newtown, PA, USA.
Is
general: Yes
