We are a clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat non-alcoholic steatohepatitis (NASH) and other liver diseases, inflammation, fibrosis and HIV.
Our Product Candidates
Our lead product candidate, cenicriviroc, or CVC, is a first-in-class immunomodulator and dual inhibitor of CCR2 and CCR5 being evaluated for the treatment of NASH, primary sclerosing cholangitis (PSC), and as an adjunctive therapy to standard of care in HIV.
CVC is an oral, once-daily, potent immunomodulator with a high binding affinity that blocks two chemokine receptors, CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways in NASH and PSC that cause liver damage and can lead to cirrhosis, liver cancer or liver failure. We believe this novel approach will establish CVC as both a single-agent and as a cornerstone treatment in future combination regimens for NASH, for which there is currently no approved therapy.
We own world-wide rights to CVC, outside of the Republic of Korea where the company exclusively licensed the compound to Dong-A ST.
Evogliptin is an orally bioavailable, selective dipeptidyl peptidase-4 (DPP-4; CD26 antigen) inhibitor. DPP-4 inhibitors control glucose levels by preventing the breakdown of the incretin hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), which stimulate insulin secretion in response to the increased levels of glucose in the period following meals. In October 2015, evogliptin was approved in the Republic of Korea for blood glucose control in patients with type 2 diabetes mellitus. Evogliptin is not currently approved by the FDA.
We acquired exclusive rights to develop and market evogliptin in combination with CVC and as a single agent in the United States, Canada, Europe and Australia for all therapeutic indications from Dong-A ST.
Our goal is to become a leading biopharmaceutical company developing and commercializing innovative immunomodulatory therapies for NASH, liver disease, fibrosis and inflammation. A key element is building a multi-therapy NASH-focused company. To achieve this, we are planning to:
- Complete clinical development and seek regulatory approval of CVC in NASH. NASH is a disease driven by the growing epidemic of obesity, with a significant unmet need for approved therapies that are effective and well tolerated. CVC is an excellent candidate for the chronic treatment of NASH due to its safety profile and first-in-class dual mechanism of action targeting CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways that cause liver damage and often lead to cirrhosis, liver cancer or liver failure in NASH.
- Establish commercial capabilities to market CVC as a leading treatment for NASH. If approved, the company intends to establish a specialty sales force and develop targeted commercial capabilities in key geographies to promote CVC to liver specialists and other physicians treating this disease. Patients with NASH are primarily managed by a concentrated group of liver specialists in the United States and Europe.
- Advance the company's leadership position in NASH through development of combination regimens. NASH will ultimately be a disease best treated through combination regimens. CVC has an attractive profile as a cornerstone therapy for combination regimens we plan to pursue development of CVC in combination with eveogliptin and potentially other agents for NASH through collaboration, in-licensing or acquisition of additional product candidates for NASH.
- Grow the pipeline through additional indications for CVC including orphan indications. CVC has the potential to be an effective immunomodulatory treatment for other CCR2 and CCR5 mediated inflammatory and fibrotic driven diseases such as PSC, a rare liver disease. We initiated a proof of concept Phase 2 study of CVC in PSC in the first quarter of 2016. We are also evaluating CVC in HIV as a potential adjunctive treatment for patients on anti-retroviral regimens through investigator-sponsored studies and will continue to seek collaborators or non-dilutive financing for HIV studies.