VBL Therapeutics has initiated Phase 2 efficacy and safety study evaluating lead compound VB-201 for the treatment of patients with psoriasis. VB-201, orally-administered immune response modifier expected to reduce inflammation in a broad range of conditions such as psoriasis.
The Phase 2 double-blind, randomised, dose-ranging, placebo-controlled study is expected to 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.
VB-201 has successfully completed four Phase 1 clinical trials involving 120 subjects under a US investigational new drug (IND) application. These Phase 1 trials demonstrated that VB-201 was well tolerated with a favorable safety profile.
Reportedly, the preclinical studies indicate that VB-201 has 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. In preclinical studies, VB-201 showed robust anti-atherosclerosis effect; this suggests that VB-201 could provide significant further benefit to psoriasis patients.
The company said that based on the positive preclinical results, a sub-study including several of the participating US 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.
Dror Harats, CEO of VBL Therapeutics, said: “The availability of a new oral therapy that is convenient, safe and effective would be an important treatment advance for patients with psoriasis. 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.”