Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1093884 · 2 trials · 3 indications
Area under the concentration vs. time curve from time 0 to the last data point \> LLOQ
AUC(0-tlast) divided by dose
Maximum observed drug concentration in measured matrix after single dose administration
Cmax divided by dose
Adverse events including abnormal laboratory findings and local injection site reactions
AUC from time 0 to the last data point \> LLOQ (lower limit of quantitation)
AUC(0-last) divided by dose
Maximum observed drug concentration in measured matrix after single dose administration
Cmax divided by dose
| Arm | Type | Description |
|---|---|---|
| BAY1093884 in subjects with Hemophilia | EXPERIMENTAL | Single dose of BAY1093884 over 30 minutes administered in subjects with severe congenital Hemophilia A or B, with inhibitors or without inhibitors |
| Without inhibitors | EXPERIMENTAL | Dose escalation steps for participants without inhibitors - intravenous infusion and subcutaneous injection |
| With inhibitors | EXPERIMENTAL | Dose escalation steps for participants with inhibitors - intravenous infusion and subcutaneous injection |
| Without inhibitors_multiple dose | EXPERIMENTAL | Multiple dose cohort for participants without inhibitors - a single subcutaneous injection once a week for 6 weeks |
| Name | Type | Description |
|---|---|---|
| BAY1093884 | DRUG | 0.3 mg/kg given intravenously |
Inclusion Criteria: * Males with severe congenital hemophilia A or B defined as \<1% FVIII or \<2% FIX concentration by measurement at the time of screening or from reliable prior documentation (e.g., measurement in other clinical Bayer trials, or diagnostic genetic testing) * Male with any inhibit...
Top 8 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 15 | PHASE3 | Concizumab, Mim8, Denecimig, NNC0442-0344 A, turoctocog alfa pegol |
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Fitusiran, efanesoctocog alfa |
| Pfizer Inc. | PFE | 8 | PHASE3 | Fidanacogene elaparvovec, Marstacimab |
| BioMarin Pharmaceutical Inc. | BMRN | 2 | PHASE3 | Valoctocogene roxaparvovec |
| Hoffmann-La Roche | RHHBY | 8 | PHASE3 | Emicizumab, NXT007, SPK-8011QQ, SPK-8011, SPK-8016 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | REGV131, LNP1265 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE1 | AskBio009 |
| Bayer | BAYRY | 6 | - | Damoctocog-alfa-pegol |
BAY1093884 is an investigational therapy being developed for the treatment of hemophilia A and hemophilia B. It is designed to address bleeding in patients with severe forms of these inherited bleeding disorders. It has not been approved for any indication and remains in clinical development.
BAY1093884 targets tissue factor pathway inhibitor, or TFPI. It acts as an inhibitor of TFPI. By inhibiting TFPI, the drug is intended to enhance thrombin generation and promote blood clotting in patients with hemophilia A or B.
BAY1093884 is being developed by Bayer AG. Bayer's American Depositary Receipts trade on the OTC market under the ticker BAYRY. The company has conducted Phase 1 clinical trials of the drug in patients with severe hemophilia.
BAY1093884 is in Phase 1 clinical development. It has not been approved by the FDA or any regulatory authority. The completed Phase 1 program evaluated the drug's pharmacokinetics, pharmacodynamics, and safety in patients with severe hemophilia A or B.
BAY1093884 has been studied in two completed Phase 1 trials: NCT02571569, which evaluated single and multiple escalating doses in patients with severe hemophilia A or B, and NCT03481946, which assessed pharmacokinetics and pharmacodynamics in patients with severe hemophilia. Both trials have been completed.