Virobay and LEO Pharma Initiate a Phase 1 Trial of VBY-891, a Compound Intended for Oral Treatment of Psoriasis

MENLO PARK, California and BALLERUP, Denmark, March 18, 2013 /PRNewswire/ --

Virobay, Inc. and LEO Pharma A/S today 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.

(Logo: http://photos.prnewswire.com/prnh/20130221/595427 )

The first Phase 1 trial of VBY-891 is a double-blind, randomized, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of VBY-891 in healthy adults.

"The initiation of this Phase 1 trial represents a significant development objective for Virobay's collaboration with LEO Pharma," stated Robert Booth, Ph.D., Chief Executive Officer of Virobay. "Virobay has plans to initiate clinical studies with additional cathepsin inhibitors during 2013 as we seek to develop new therapies for underserved diseases. Published prelinical data suggest that cathepsin S inhibition may provide a therapeutic benefit in patients with dermatological disorders such as psoriasis. In addition, our own preclinical data with selective cathepsin S inhibitors has demonstrated efficacy in models of both psoriasis and atopic dermatitis," stated Robert Booth. "We look forward to assessing the data from these Phase 1 trials, which will incorporate the evaluation of several biomarkers, to guide our Phase 2 clinical development plans for VBY-891."

"Reaching this important milestone in our collaboration with Virobay brings us one step closer to provide an oral treatment for psoriasis patients. We believe that VBY-891 has the potential to provide an oral treatment that may alleviate symptoms of psoriasis. LEO Pharma strives to constantly expand and improve treatment options for patients and this is an important example of our commitment to meeting patient needs. To the best of our knowledge, the VBY-891 compound has the potential to be the first in class on the market," said Kim Kjller, Senior Vice President, Global Development, LEO Pharma.

Background

About Cathepsin S and VBY-891

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 that is a potent, competitive and reversible inhibitor of purified cathepsin S.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.

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Virobay and LEO Pharma Initiate a Phase 1 Trial of VBY-891, a Compound Intended for Oral Treatment of Psoriasis