close

Clinical Trials

Date: 2017-04-03

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the H.C. Wainwright 1st Annual NASH Investor Conference,

Company: VBL Therapeutics (Israel)

Product: VB-703

Action mechanism:

  • lecinoxoid. 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: NASH (non-alcoholic steatohepatitis), liver fibrosis

Therapeutic area: Liver diseases - Hepatic diseases

Country:

Trial details:

Latest news:

  • • On April 3, 2017, VBL Therapeutics announced that in a post-hoc, hypothesis-driven analysis of data from completed Phase 2 studies,  VB-201 appears to reduce certain liver enzymes.  The data have been presented at the H.C. Wainwright 1st Annual NASH Investor Conference, at the St. Regis Hotel in New York City. The analysis was conducted following the effect seen with VB-201 in pre-clinical models for non-alcoholic steatohepatitis (NASH) and renal fibrosis, in which VB-201 and VB-703, a next-generation Lecinoxoid drug candidate, reduced inflammation and fibrosis without affecting the lipid profile or steatosis. VBL has studied VB-201 in five Phase 1 studies and three Phase 2 studies, some of which included patient populations known to have high rates of metabolic syndrome (e.g. psoriasis). In a retrospective analysis of liver enzyme tests performed for subjects dosed with VB-201, the company identified a statistically significant time- and dose- dependent reduction of alkaline phosphatase (ALP) blood levels in patients treated orally with VB-201, which was reversed during a 4-week follow-up period after the patients completed the study. A similar but milder reduction was seen with levels of gamma-glutamyltransferase (GGT), an additional enzyme induced in liver damage. In the NASH setting, ALP and GGT may serve as biomarkers and lowering of ALP and GGT levels may indicate improvement in liver fibrosis. The decrease in ALP and GGT levels is in correlation with the Lecinoxoids anti-inflammatory/anti-fibrotic mechanism of action.
  • • On April 19, 2016, VBL Therapeutics reported the publication of results for drug candidates VB-201 and VB-703 for the treatment of non-alcoholic steatohepatitis (NASH) and liver fibrosis in Digestive Diseases and Sciences magazinePrevious studies have demonstrated that Toll-like receptors 2 and 4 (TLR-2 and TLR-4) play a role in nonalcoholic fatty liver disease. VBL has developed the Lecinoxoids, small molecules that antagonize TLR-2- and TLR-4-mediated activation and inhibit monocyte migration. Now VBL's novel findings demonstrate that Lecinoxoids can restrict liver inflammation and ameliorate liver fibrosis in a mouse model. (Treatment with Oxidized Phospholipids Directly Inhibits Nonalcoholic Steatohepatitis and Liver Fibrosis Without Affecting Steatosis).

Is general: Yes