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Also known as BAY94-9027
BAY94-9027+ Recombinant Factor VIII · 3 trials · 1 indication
Pharmacokinetics profile includes maximum concentration (Cmax), half-life (t1/2), area under the concentration versus time curve (AUC), mean residence time (MRT), volume of distribution at steady state (Vss), and clearance (CL)
Annualized number of total bleeds was defined as the annualized sum of spontaneous bleeds and trauma bleeds. A participant who had the one-time increase in dose frequency was regarded as rescued. A rescue bleed was a bleed that occured after the dose frequency was increased. Rescue bleeds and periods were not considered for the annualized bleeding rate (ABR).
Antibodies to FVIII, polyethylene glycol (PEG) and BAY94-9027
Total body clearance of drug from plasma (volume/time) or (volume/time/body weight) or ((volume/time)\*(1.73/body surface area)) calculated after intravenous administration
Based on the chromogenic, one-stage and PEG capture assays
Recovery was assessed using two different assays (chromogenic and one-stage assay)
| Arm | Type | Description |
|---|---|---|
| Main study | EXPERIMENTAL | Participants were treated and prophylaxis administered with BAY94-9027 at a dose of 25-60 international units/kilogram (IU/kg) twice per week or 45-60 IU/kg every 5 days or 60 IU/kg every 7 days as an intravenous (IV) infusion as per clinical needs of each subject up to at least 50 exposure days (EDs) and a minimum of at least 6 months. |
| Part 2 (Expansion group) | EXPERIMENTAL | Participants were administered with BAY94-9027 at a dose of 25-60 IU/kg twice per week for prophylaxis for 12 weeks. |
| Extension study | EXPERIMENTAL | Participants were treated and prophylaxis administered with BAY94-9027 at a dose of 25- 60 IU/kg twice per week or 45-60 IU/kg every 5 days or 60 IU/kg every 7 days as an IV infusion as per clinical needs of each subject for at least 50 EDs or until marketing authorization of the drug. |
| Arm 1 | EXPERIMENTAL | On-demand treatment of BAY94-9027 at individual dose and number of infusions based upon location and severity of bleeds |
| Arm 2 | EXPERIMENTAL | Prophylaxis treatment of BAY94-9027; 2 infusions per week over 10 weeks followed by 2 infusions per week over 26 weeks in the main trial; and at least 1 day per week in the extension for at least 100 ED |
| Arm 3 | EXPERIMENTAL | Prophylaxis treatment of BAY94-9027; 2 infusions per week over 10 weeks followed by infusion every 5 days over 26 weeks in the main trial; and at least 1 day per week in the extension for at least 100 ED |
| Arm 4 | EXPERIMENTAL | Prophylaxis treatment of BAY94-9027; 2 infusions per week over 10 weeks followed by infusion every 7 days over 26 weeks in the main trial; and at least 1 day per week in the extension for at least 100 ED |
| Name | Type | Description |
|---|---|---|
| BAY94-9027 | BIOLOGICAL | Study drug dosing was adjusted to the clinical needs of each subject in the range of 25-60 IU/kg/administration, intravenous infusion, at least 50 EDs and a minimum of at least 6 months |
| BAY94-9027 + Recombinant Factor VIII (Kogenate FS, BAY14-2222) | BIOLOGICAL | Single dose of Kogenate FS and 16 doses of BAY94-9027 given 2 times a week for 8 weeks. Both drugs to be given intravenously. |
| BAY94-9027 + Recombinant Factor VIII (Kogenate FS, BAY14-2222)) | BIOLOGICAL | Single dose of Kogenate FS and 9 doses of BAY94-9027 given once a week for 8 weeks. Both drugs to be given intravenously. |
Inclusion Criteria: * Males \< 12 years of age * Subjects with severe hemophilia A * Previously treated with FVIII for \> 50 exposure days Exclusion Criteria: * Subjects with current evidence of or history of inhibitors to FVIII * Any other inherited or acquired bleeding disorder * Platelet count...
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 |
BAY94-9027 is being developed for the treatment of hemophilia A, a bleeding disorder. It is a recombinant factor VIII product studied in previously treated male patients with hemophilia A, including children and adults. All three of its clinical trials enrolled patients with hemophilia A.
BAY94-9027 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating the recombinant factor VIII product in hemophilia A.
BAY94-9027 has completed Phase 3 clinical development. Its Phase 3 trial, NCT01775618, evaluated safety and efficacy in previously treated male children with hemophilia A. The program also includes a completed Phase 2 trial, NCT01580293, and a completed Phase 1 trial, NCT01184820.
BAY94-9027 has been studied in three completed trials: NCT01775618, a Phase 3 trial in previously treated male children with hemophilia A; NCT01580293, a Phase 2 trial in severe hemophilia A; and NCT01184820, a Phase 1 pharmacokinetics and safety trial. Total enrollment across the program was 232 patients.
BAY94-9027 is also known as BAY94-9027 plus recombinant factor VIII, and it has been referenced alongside Kogenate FS and BAY14-2222. These names appear in connection with the same Bayer recombinant factor VIII hemophilia A development program.
The BAY94-9027 clinical program enrolled 232 patients in total across three completed trials. The Phase 3 trial NCT01775618 enrolled 73 children, the Phase 2 trial NCT01580293 enrolled 145 patients aged 12 years and older, and the Phase 1 trial NCT01184820 enrolled 14 adults.