Pfizer abandons cholesterol busting mAb and cancels trials being run by Icon

By Gareth Macdonald

- Last updated on GMT

iStock/Ugreen
iStock/Ugreen

Related tags Clinical trial

Pfizer has said it will stop working on bococizumab and cease late phase trials of the monoclonal antibody (mAb) cholesterol buster being run by Ireland-based CRO, Icon.

The US drug company announced it had halted development of bococizumab on Tuesday. It explained that available clinical data indicate the drug becomes less effective over time and is associated with more injection site reactions than rival drugs.

Pfizer said: “The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide value to patients, physicians, or shareholders​.”

Clinical programme

Bococizumab’s ability to lower LDL-C has been examined in several Phase III clinical studies, all of which were completed in the past six months. The drug’s impact on cardiovascular outcomes is also being examined in two trials, SPIRE 1​ and 2​.

Pfizer said it will halt the cardiovascular outcome studies and right off development costs as an R&D charge on the fourth quarter.

All the trials were run by Ireland-based contract research organisation Icon​, under a strategic agreement signed in 2011​. According to Clinicaltrials.gov, more than 27,000 subjects had been involved in the bococizumab at 3,000 plus sites.

Icon declined to comment when contacted by this publication.

Analysts view

Jefferies analyst David Windley predicted that Pfizer’s decision, particularly the discontinuation of the outcomes studies, will have a significant impact on the CROs financial performance.

He predicted in a note to investors that: “We believe bococizumab accounted for as much as 1/3 of ICLR's 2015 PFE revenue when all Phase III and CVO studies were active.

With only the CVO studies remaining, ICLR's overall exposure to bococizumab has been reduced, but the size of the CVO studies still will cause a material decline in FY17 revenue​” he added.

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