May 6, 2013

Another one bites the dust

Bad news for Bayer this week. The company has just announced the discontinuation of a Phase II/III trial evaluating the efficacy and safety of BAY 86-6150 in people with hemophilia A and hemophilia B with inhibitors.

It was hoped that the product, a recombinant factor VIIa (rFVIIa) protein, would reduce the dosing frequency as compared to the currently available recombinant bypassing agent as a result of minor modifications in the amino acid composition that would increase the circulating half-life and alter its affinity to activated platelets.

A Phase I multicenter, randomized, double-blind, placebo-controlled, single-dose escalation study on BAY86-6150 had been successfully completed and the Phase II/III TRUST (TReatment with Unique recombinant FVII STudy) study had recruited its first cohort.

Sadly, a company statement on Friday indicated this had now been discontinued "due to the detection of a neutralizing antibody in the trial."