ChemoCentryx, Inc. (CCXI) reported positive top-line results from the first two steps of the phase II CLEAR (C5aR inhibitor on Leukocytes Exploratory ANCA-associated Renal Vasculitis) study on its candidate, CCX168. A C5aR (chemoattractant receptor) inhibitor, CCX168 is being developed for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated renal vasculitis (AARV).
Results from the study revealed that CCX168 was generally safe and well tolerated. The candidate was also successful in the reduction and elimination of high-dose corticosteroids, a part of standard of care for patients suffering from AARV. Moreover, the efficacy or safety profile of the candidate was not hampered during the reduction and elimination of high-dose corticosteroids.
ChemoCentryx also reported improvements in a number of renal health parameters like renal remission, albuminuria and Birmingham vasculitis activity score (BVAS), in patients under CCX168 compared to those under standard of care treatment. No unexpected serious adverse events were observed in patients under CCX168 during the study.
We note that in Aug 2006, ChemoCentryx had entered into a worldwide strategic agreement with GlaxoSmithKline (GSK) for CCX168. Two other candidates, vercirnon (Crohn’s disease) and CCX354 (rheumatoid arthritis), were also part of the agreement. ChemoCentryx stated in its press release that Glaxo has rejected its option to license CCX168.
As a result, ChemoCentryx regained full development and commercial rights of CCX168. In Sep 2013, Glaxo returned all rights to vercirnon and ChemoCentryx became solely responsible for developing vercirnon for all indications including inflammatory bowel disease and Crohn's disease.
Glaxo took this decision after vercirnon failed to meet both the primary and the key secondary endpoint in the SHIELD-1 phase III study (first of four phase III studies) in Aug 2013. Glaxo was evaluating the use of vercirnon in adults suffering from moderately-to-severely active Crohn’s disease.
ChemoCentryx presently carries a Zacks Rank #3 (Hold). Some better ranked stocks include Actelion Ltd. (ALIOF) and AMAG Pharmaceuticals, Inc. (AMAG). Both stocks carry a Zacks Rank #1 (Strong Buy).
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