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Virobay Inc. Initiates a Phase 1 Trial of VBY-036, a Compound Intended for the Treatment of Neuropathic Pain


5/23/2013 9:53:51 AM

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MENLO PARK, Calif., May 23, 2013 /PRNewswire/ -- Virobay, Inc. today announced that their development of an oral treatment for pain has reached an important milestone, as Virobay has now initiated a Phase 1 clinical trial of VBY-036 - a selective cathepsin S inhibitor.

The first Phase 1 trial of VBY-036 is a double-blind, randomized, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of VBY-036 in healthy adults.

"The initiation of this Phase 1 trial with VBY-036 represents another significant development objective for Virobay," stated Robert Booth, Ph.D., Chief Executive Officer of Virobay. "Published preclinical data suggest that cathepsin S inhibition may provide a therapeutic benefit in patients with a variety of painful disorders, including neuropathic pain. In addition, research carried out by Virobay with selective cathepsin S inhibitors has demonstrated efficacy in preclinical models of both acute and chronic inflammatory pain and neuropathic pain," 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-036. To the best of our knowledge, VBY-036 is first-in-class with this therapeutic approach for the treatment of pain."

"Reaching this important milestone brings us one step closer to providing a new treatment for patients suffering with painful conditions. Virobay is committed to providing novel therapies for unmet medical needs and strives to constantly expand and improve treatment options for patients. Virobay also initiated clinical studies with VBY-891, a selective cathepsin inhibitor in March of this year. VBY-891 is being developed in partnership with LEO Pharma for the therapy of dermatological diseases," said Robert Booth.

Background

About Cathepsin S and VBY-036

Cathepsin S is a member of the cysteine protease family of cathepsin inhibitors that catalyzes proteolytic cleavage of membrane-bound fractalkine from the surface of neurons to release soluble fractalkine. Fractalkine is a potent chemokine that stimulates the recruitment of inflammatory cells to the sites of neuronal damage and activates microglia. Microglia are macrophage-like cells that are implicated as key drivers in the pathogenesis of chronic neuropathic pain syndromes. In model systems, cathepsin S mediated microglial activation is essential in the development of pain. The inhibition of cathepsin S results in a reduction in pain, as well as prevention of pain in preclinical models of chemotherapy-induced neuropathic pain and diabetic neuropathy.

VBY-036 is an optimized cathepsin S inhibitor that is a potent, competitive and reversible inhibitor of cathepsin S. It has picomolar inhibitory potency against the isolated cathepsin S enzyme and nanomolar activity in cellular assays. VBY-036 is also highly selective against related human cathepsins as well as other enzymes, and sustained cathepsin S inhibition after oral dosing has been demonstrated in vivo through the use of a biomarker. The compound has been tested in pre-clinical studies and is now entering the next phase - a phase 1 clinical trial in healthy human volunteers. The VBY-036 program is a novel approach to the treatment of pain and may result in a safe and effective oral therapeutic for an important unmet medical need.

About Virobay, Inc.

Founded in 2006, Virobay is a leader in the design, synthesis and development of small molecule inhibitors of cysteine proteases, a class of enzymes that are key mediators in a variety of diseases, including autoimmunity, neuropathic pain, liver disease, cancer and cardiovascular disorders. Virobay's clinical pipeline currently includes product candidates in dermatological diseases, autoimmune disease, neuropathic pain, and liver fibrosis. For more information, please visit www.virobayinc.com

Contact
Robert Booth, President and CEO, Virobay, +1 650 833 5703
Email: rbooth@virobayinc.com

SOURCE Virobay, Inc.



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