Date: 2013-03-18
Type of information:
phase: 1
Announcement: initiation
Company: Leo Pharma (Denmark) Virobay (USA)
Product: VBY-891
Action mechanism: Cathepsin S is a member of the cysteine protease family of cathepsin inhibitors that catalyzes the final proteolytic step in the processing of invariant chain in specific antigen presenting cells. This step is essential in the maturation and loading of MHC Class II with antigenic peptides and subsequent activation of CD4+ T cells. Continuous presentation of antigenic self-peptides is thought to be involved in the maintenance of chronic disease in autoimmune disorders, including psoriasis. Inhibition of cathepsin S is likely to result in a reduction in antigen presentation without an impact on innate immunity. VBY-891 is a next generation cathepsin S inhibitor. It has picomolar inhibitory potency against the cathepsin S enzyme and nanomolar inhibitory potency in cellular assays. VBY-891 is also highly selective against human cathepsins L, B, F and K. Sustained cathepsin S inhibition after oral dosing has been demonstrated in vivo through the use of a biomarker. VBY-891 shows potent inhibitory activity in models of autoimmunity and neuropathic pain. Therefore, inhibition of cathepsin S may have therapeutic potential across a range of dermatological conditions.
Disease: psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country:
Trial details: The first Phase 1 trial of VBY-891 is a double-blind, randomised, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of VBY-891 in healthy adults.
Latest
news: Virobay and Leo Pharma have announced that their collaboration on the development of an oral treatment for psoriasis has reached an important milestone as Virobay has now initiated a Phase 1 clinical trial of VBY-891 - a selective cathepsin S inhibitor. This double-blind, randomised, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VBY-891 will incorporate the evaluation of several biomarkers, to guide Phase 2 clinical development plans.
This collaboration between Virobay and Leo Pharma was entered in 2012 when the danish dermatology group in-licensed this compound from Virobay. After this phase 1 trial has been completed, the plan is to do testing on psoriasis patients later this year.
