BAY 866150 / Bayer - LARVOL DELTA

A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150 (clinicaltrials.gov) - P2/3; N=10; Terminated; Sponsor: Bayer; Completed -> Terminated

Trial termination • Biosimilar • Hematological Malignancies • Hemophilia

Predicting dosing advantages of factor VIIa variants with altered tissue factor and lipid-dependent activities (J Thromb Haemost) - "The PK/PD simulations agreed with published ex vivo TG data for rFVIIa and BAY 86-6150 variant and explained the similar efficacy of a single dose of 270 μg/kg (as reported in the literature) and repeated doses of 90 μg/kg of unmodified rFVIIa. The duration of the simulated hemostatic effect after a single optimal dose was prolonged in rFVIIa variants with increased TF affinity or extended half-life, but not for those with modulated PL activity."

PK/PD data • Hemophilia

New York Management Meet (Bayer) - Anticipated initiation of P2/P3 study for hemophilia in 2012

Anticipated P2/3 trial initiation • Hemophilia

Bayer provides update on phase II/III trial of BAY 86-6150 (Bayer) - "Bayer...announced that a Phase II/III trial evaluating the efficacy and safety of BAY 86-6150 in people with hemophilia A and hemophilia B with inhibitors has been discontinued. Due to safety concerns, we are discontinuing the BAY 86-6150 trial as a precautionary measure."

Trial termination • Hemophilia

Deutsche Bank Healthcare Conference (Bayer) - Anticipated initiation of combined P2/3 trial for hemophilia in 2012

Anticipated trial initiation date • Hemophilia

A phase 2/ 3 trial to evaluate the efficacy and safety of BAY86-6150 (clinicaltrials.gov) - P2/3, N=65; Not yet recruiting; New P2/3 trial

New P2/3 trial • Pipeline shift • Hemophilia