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: psoriasis
Therapeutic
area: Autoimmune diseases - Dermatological diseases
Country: Germany, Poland, Spain, Israel
Trial
details:
- The Phase 2 clinical study in patients with psoriasis is a randomized, double-blind, placebo-controlled study in patients with moderate to severe plaque psoriasis, designed to evaluate the efficacy and safety of VB-201. The trial is being conducted at sites in Germany, Poland, Spain and Israel. (NCT01837420)
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 80 mg or 160 mg daily for 24 weeks. The study evaluated 194 patients with moderate to severe plaque psoriasis. The primary efficacy endpoint of the study was PASI 50, or the proportion of patients who achieve at least 50 percent improvement from baseline PASI score, at weeks 16 and 24. No effect of VB-201 compared to placebo was observed on the primary or secondary endpoints at either dose level tested. The PASI 50 for VB-201 patients was 26.4% at 16 weeks and 34% at 24 weeks, with no significant difference between the 80 mg and 160 mg dose cohorts. The placebo PASI 50 at week 16 was 38%. VB-201 was safe and well-tolerated. There were no drug-related serious adverse events.
- • On June 20, 2014, VBL Therapeutics, a clinical-stage biotechnology company committed to the development of first-in-class treatments for immune-inflammatory diseases and cancer, 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. This is the second Phase 2 trial for VB-201 in psoriasis. VBL recently completed a pilot double-blind, placebo-controlled Phase 2 trial in which VB-201 (administered at daily doses of 20 or 80 mg) was well-tolerated and showed statistically significant improvements across multiple measures of disease severity over a twelve-week period. Disease measures continued to improve throughout the study and did not reach a plateau at the study's conclusion.
Is
general: Yes
