VBL’s oral pill to treat psoriasis VB-201 enters crucial phase of clinical trial

VB-201, an oral immune response modifier pill to treat psoriasis, has entered phase 2 human studies.

A phase 2 study to evaluate efficacy and safety of the lead compound VB-201 for the treatment of patients with psoriasis has been initiated at multiple centers in the United States, Germany and Israel, according to a VBL Therapeutics press release.

VB-201 is poised to be a first-in-class, orally-administered immune response modifier expected to reduce inflammation in a broad range of conditions such as psoriasis.

The Phase 2 double-blind, randomized, dose-ranging, placebo-controlled study will enroll approximately 180 patients with moderate to severe psoriasis.

Patients will receive VB-201 or placebo once-daily for 12 weeks.

The primary endpoint in the VB-201 study is at least 75% improvement in the Psoriasis Area and Severity Index at week 12, or PASI 75.

“The availability of a new oral therapy that is convenient, safe and effective would be an important treatment advance for patients with psoriasis,” said Dror Harats, M.D., chief executive officer of VBL Therapeutics.

VB-201 is a lead oncology drug candidate from VBL Therapeutics.

VB-201 has successfully completed four Phase 1 clinical trials involving 120 subjects.

Preclinical studies indicate that VB-201 has significant potential to treat inflammation in chronic diseases such as psoriasis, rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease, and also found to bring about regression of atherosclerosis.

VB-201 is the first in a new class of drugs and the lead candidate of several proprietary phospholipid analogs from the Lecinoxoid family that were designed to be orally-available, anti-inflammatory medicines.

VB-201 is believed to act by inhibiting the production of the pro-inflammatory cytokines IL-12/23p40 by dendritic cells and macrophages.

VB-201 acts as a counterbalance to the pro-inflammatory immune system activity that occurs in chronic disorders without significantly affecting system-wide immune factors, and is well-positioned to either work as a standalone or a combined therapy.

Atherosclerotic cardiovascular disease has recently been recognized as a major cause of morbidity and mortality in psoriasis patients.

In preclinical studies, VB-201 showed robust anti-atherosclerosis effect; this suggests that VB-201 could provide significant further benefit to psoriasis patients.

A sub-study including several of the participating U.S. sites will be conducted during the Phase 2 psoriasis trial to evaluate the effect of VB-201 on atherosclerosis in psoriasis patients, the VBL Therapeutics release said.

The estimated market for psoriasis biologics is currently valued at more than $2 billion and is projected to rise to more than $3 billion by 2011.

Many of the available psoriasis treatments require subcutaneous injection by patients, often have serious side effects (e.g., infections, malignancies, progressive multifocal leukoencephalopathy), and are cost prohibitive for a number of patients and payers.

Psoriasis is a chronic, progressive autoimmune disease with debilitating physical and quality of life consequences for patients.

There are more than 125 million people suffer from psoriasis worldwide, with more than seven million patients in the United States, according to World Health Organization estimates.

Psoriasis is characterized by inflamed, swollen, scaly patches of skin. It can be limited to a few spots or can involve more extensive areas of the body, appearing most commonly on the scalp, knees, elbows and body. Currently, there is no cure for psoriasis.

VBL Therapeutics develops treatments for immuno-inflammatory diseases and cancer.

VBL has pioneered the Lecinoxoid class of oral anti-inflammatory agents and VB-201 is the lead candidate from this program, which has entered Phase 2 clinical development in patients with psoriasis.

Based in Tel Aviv, Israel, VBL has a proprietary Vascular Targeting System (VTS) technology platform that has yielded VB-111, the first dual-action, anti-angiogenic and vascular disruptive agent (VDA) for cancer, which is expected to enter Phase 2 clinical trials in 2010. VBL has 55 granted patents and more than 115 patents pending.