We are a clinical-stage pharmaceutical company utilizing our cysteine cathepsin platform for the development and commercialization of novel drugs. We believe cysteine cathepsins are critically important enzymes in the biology of many diseases. By inhibiting these enzymes we believe we can develop safer and more effective therapies for these diseases. Our current programs are focused on addressing significant unmet medical needs for the treatment of neuropathic pain, autoimmune diseases and fibrosis.
Our most advanced product candidate, VBY-036, is scheduled to enter Phase 2 clinical trials for neuropathic pain in the first half of 2015 and for Crohnís disease in the second half of 2015. We retain worldwide rights to VBY-036 in all indications. VBY-891, which we are developing in partnership with, and have licensed worldwide rights to certain dermatological conditions to, LEO Pharma A/S, or LEO, is scheduled to enter into Phase 2 clinical trials for psoriasis in the first half of 2015. We also have two earlier stage product candidates directed towards fibrotic liver disease, with VBY-376 targeting nonalcoholic steatohepatitis, or NASH, and VBY-825 targeting primary biliary cirrhosis, or PBC.
Cathepsins are enzymes that regulate essential processes in cells by cleaving certain proteins. Over the past 20 years, substantial evidence suggests that in many diseases, the normal function of cathepsins becomes pathological, contributing to or causing disease. Although the long term effects of cathepsin inhibition are unknown, and may include risks such as target-based toxicity, we believe cathepsins are attractive targets for small molecule drug design because of their important roles in disease and well characterized structures. Others have attempted to develop compounds that inhibit cathepsins but have had limited success due to lack of potency and toxicity. One source of toxicity now known in scientific literature is that certain chemical groups used in some cathepsin inhibitors can cause accumulation in an important cellular compartment known as the lysosome. By eliminating these chemical groups from our inhibitors we addressed this specific toxicity issue. Furthermore, we designed and selected our compounds with extremely high potency. Applying our decades of experience in the discovery and development of cathepsin inhibitors, we believe we have potent candidates that do not accumulate in the lysosome. By removing the chemical groups associated with toxicity and by targeting highly potent compounds we believe our compounds have a greater likelihood of success in clinical trials.
We believe our product candidates have one or more of the following attributes that will commercially differentiate them from existing and emerging therapies:
The foundation of our proprietary cathepsin platform and our management team were spun-out from Celera Genomics Corporation, or Celera, which was then a leader in cathepsin research. In the addition to our platform, Celera research produced ibrutinib, the Brutonís tyrosine kinase inhibitor, developed by Pharmacyclics, Inc. for the treatment of patients with mantle cell lymphoma and collaborated on the discovery of odanacatib, a cathepsin K inhibitor being developed by Merck for treatment of osteoporosis.