MENLO PARK, California and BALLERUP, Denmark, March 18, 2013 /CNW/ -
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 preclinical 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 Kjøller,
Senior Vice President, Global Development, LEO Pharma.
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.
About the collaboration
The multi-million dollar collaboration between Virobay Inc. and LEO
Pharma A/S was entered in 2012 when LEO Pharma in-licensed the
promising compound from Virobay. The collaboration agreement involves
up-front payment to Virobay of USD 7m, followed by milestone payments
totalling up to USD 300m and tiered to royalties. The compound has been
tested in pre-clinical studies and the project is now entering the next
phase - a phase 1 clinical trial in healthy human volunteers. After
this trial has been completed, the plan is to do testing on psoriasis
patients later this year. If the process proceeds as planned, the
collaboration may result in an oral treatment for psoriasis in 6-7
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 autoimmune disease, neuropathic pain and
liver fibrosis. For more information, please visit http://www.virobayinc.com
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions
to patients in more than 100 countries globally, LEO Pharma supports
people in managing their skin conditions. Founded in 1908 and owned by
the LEO Foundation, the healthcare company has devoted decades of
research and development to delivering products and solutions to people
with skin conditions. LEO Pharma is headquartered in Denmark and
employs approximately 5,000 people worldwide.
For more information, visit http://www.leo-pharma.com.
SOURCE: Virobay, Inc.
For further information:
Contact: Robert Booth, President and CEO, Virobay, +1-650-833-5703; Eva Louise Østergaard, Senior Communications Manager, LEO Pharma, +45-4137-1207, mail: email@example.com