befovacimab (BAY 1093884) / Bayer, Novartis - LARVOL DELTA

Befovacimab, an anti-tissue factor pathway inhibitor antibody: Early termination of the multiple-dose, dose-escalating Phase 2 study due to thrombosis. (PubMed, Haemophilia) - P2 | "Despite favourable initial results from preclinical and clinical studies, a positive safety profile of befovacimab was not confirmed. The lack of SAE-related laboratory abnormalities or differentiating PK/PD characteristics in participants experiencing SAEs raises concerns about the predictability of thrombosis following befovacimab treatment and emphasises the need for further investigation into the therapeutic window of anti-TFPI treatment."

Journal • P2 data • Cardiovascular • Hematological Disorders • Hemophilia • Rare Diseases • Thrombosis

Progress in the Development of Anti-tissue Factor Pathway Inhibitors for Haemophilia Management. (PubMed, Front Med (Lausanne)) - "The anti-TFPIs have several advantages, including their bioavailability when administered subcutaneously, their stable pharmacokinetics and their ability to prevent bleeds in haemophilia A or B patients with and without inhibitors. Whether these advantages can be realized will depend on the outcome of the currently ongoing studies."

Journal • Review • Cardiovascular • Hematological Disorders • Hemophilia • Rare Diseases • Thrombosis

An in vitro pharmacodynamic spiking study of befovacimab, a tissue factor pathway inhibitor monoclonal antibody, in blood samples from patients with severe FVIII deficiency. (PubMed, Haemophilia) - "Befovacimab has modest dose-response effects from 0.5 to 10 nM with minimal improvement with higher concentrations. In vitro befovacimab blood concentrations of 5 to 10 nM had pro-coagulant effects similar to blood supplemented with rFVIII 10- to 40%."

Journal • PK/PD data • Preclinical • Hematological Disorders • Hemophilia • Rare Diseases • Thrombosis

[VIRTUAL] ANTI-TFPI ANTIBODY BAY 1093884: EARLY TERMINATION OF PHASE II STUDY DUE TO THROMBOSIS (THSNA 2020) - No abstract available

P2 data • Cardiovascular • Hematological Disorders • Thrombosis

A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Bayer; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Gene Therapies • Genetic Disorders • Hematological Disorders • Hemophilia

Anti‐TFPI antibody bay 1093884: Early termination of phase II dose escalation study due to thrombosis (EAHAD 2020) - P2; "Despite the lack of safety concerns in two previous single-dose studies, a positive safety profile of BAY 1093884 could not be confirmed with this escalating dose study design. The absence of specific laboratory findings or any differentiating PK/PD characteristics in the patients experiencing the SAEs raises concerns about the predictability of thrombosis during treatment with BAY 1093884."

P2 data • F2

Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors (clinicaltrials.gov) - P2; N=24; Terminated; Sponsor: Bayer; Active, not recruiting ➔ Terminated; Due to thrombosis

Clinical • Trial termination

Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Bayer; N=30 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal

Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors (clinicaltrials.gov) - P2; N=24; Active, not recruiting; Sponsor: Bayer; Trial completion date: Dec 2023 ➔ Oct 2019

Clinical • Trial completion date

Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors (clinicaltrials.gov) - P2; N=24; Active, not recruiting; Sponsor: Bayer; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Bayer

Clinical • New P1 trial

Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors (clinicaltrials.gov) - P2; N=28; Recruiting; Sponsor: Bayer; Trial completion date: May 2020 ➔ Dec 2023

Clinical • Trial completion date

A Study to Assess Pharmacokinetics and Pharmacodynamics Following Administration of BAY1093884 in Patients With Severe Hemophilia (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Bayer; Active, not recruiting ➔ Completed

Clinical • Trial completion