ChemoCentryx, Inc. (CCXI) recently announced that partner GlaxoSmithKline (GSK) has returned all rights to the former’s pipeline candidate vercirnon. ChemoCentryx will now be responsible for developing vercirnon for all indications including inflammatory bowel disease and Crohn's disease.
We note that in Aug 06, ChemoCentryx entered into a worldwide strategic agreement with Glaxo for vercirnon. Two other candidates, CCX354 (rheumatoid arthritis) and CCX168 (ANCA vasculitis), were also part of the agreement.
We remind investors that last month, 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). Glaxo was evaluating the use of vercirnon in adults suffering from moderately-to-severely active Crohn’s disease.
The randomized, double-blind, placebo-controlled, 12-week study evaluated vercirnon in two doses (500 mg once daily and 500 mg twice daily) versus placebo in Crohn’s disease patients. Not only did vercirnon fail to show significant clinical response and clinical remission (reduction or disappearance of symptoms) at 12 weeks, a direct correlation was found between dosage strength of vercirnon and overall adverse event rates. Adverse events and withdrawals of patients receiving vercirnon were similar to that in the placebo arm.
The phase III development program includes four studies (SHIELD-1, SHIELD-2, SHIELD-3 and SHIELD-4), aimed to evaluated the safety and efficacy of vercirnon in more than 2,500 moderately-to-severely active Crohn’s disease patients.
ChemoCentryx will now get all data from the SHIELD studies from Glaxo to further asses the candidate.
ChemoCentryx presently carries a Zacks Rank #3 (Hold). Meanwhile, companies such as Actelion Ltd. (ALIOF) and Biogen Idec Inc. (BIIB) look better positioned with a Zacks Rank #1 (Strong Buy).
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