Phase 2 study evaluating VBL Therapeutics' lead compound VB-201 initiated

VBL Therapeutics today announced the initiation of a Phase 2 efficacy and safety study evaluating lead compound VB-201 for the treatment of patients with psoriasis. 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 availability of a new oral therapy that is convenient, safe and effective would be an important treatment advance for patients with 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 study is at least 75% improvement in the Psoriasis Area and Severity Index at week 12, or PASI 75. The study will be conducted at multiple centers in the United States, Germany and Israel. Detailed information on the clinical trial can be found at www.clinicaltrials.gov.

"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. “Building on the promising results observed preclinically and the success of our four separate Phase 1 clinical studies, we are excited to advance VB-201 into Phase 2 development for psoriasis. We look forward to launching clinical trials in additional indications in the near-term, as well as entering Phase 2 clinical development with VB-111, our lead oncology drug candidate.”

Gerald Krueger, M.D., professor of dermatology at the University of Utah School of Medicine and principal investigator for the study stated, “Psoriasis is a chronic, immune-mediated disease that manifests itself in the skin of patients. Unfortunately, the currently available therapies do not offer a cure for psoriasis and treatment efforts are focused on minimizing the burden of disease and improving its symptoms. While we have made great strides over the last several years in advancing the treatment of psoriasis, our patients remain in need of effective therapeutic options that are safe, well tolerated and easily administered. We look forward to the results from this trial and learning more about the potential role VB-201 may play for patients living with psoriasis.”

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.

VB-201 has successfully completed four Phase 1 clinical trials involving 120 subjects under a U.S. investigational new drug (IND) application. These Phase 1 trials demonstrated that VB-201 was well tolerated with a favorable safety profile. 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.

Importantly, 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.

Based on the encouraging preclinical results, 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. PET-CT scans of the great vessels of the chest and neck will measure the level of inflammation within atherosclerotic plaques, which is known to trigger vessel occlusion.

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. While advances have been made in the treatment of psoriasis over the last decade with the advent of biologics, many of these 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. There remains a significant, unmet need for a safe, effective, oral treatment option for psoriasis.