Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAX 826 · 1 trial · 1 indication
Serious Adverse Events and non-serious Adverse Events the occurred after infusion with BAX 826.
Clinically significant results after treatment with investigational product that constitute an AE are counted. Vital signs include body temperature, respiratory rate, pulse rate, and blood pressure. Clinical laboratory results include: Hematology (hemoglobin, hematocrit, red blood cell count, white blood cell count with differential (i.e. basophils, eosinophils, lymphocytes, monocytes and neutrophils), international normalized ratio (INR), mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), platelet count. Clinical Chemistry: sodium, potassium, chloride, bicarbonate, total protein, albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase, gamma-glutamyltransferase (GGT), blood urea nitrogen (BUN), creatinine, glucose. Lipid panel: cholesterol, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides
Inhibition of FVIII activity by antibodies binding to FVIII were measured using the Nijmegen modification of the Bethesda inhibitor assay.
Binding antibodies to PSA FVIII (ie BAX 826) IgG and IgM
Binding antibodies to FVIII IgG and IgM
Binding antibodies to PSA (IgG and IgM)
Binding antibodies to CHO
Binding antibodies HAMA (IgG)
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - Low dose | EXPERIMENTAL | The study is comprised of 3 dose cohorts and two dose escalation steps \[Cohort 1: 10 evaluable participants; Cohort 2: 10 evaluable participants; Cohort 3: 10 evaluable participants\]. Participants will be recruited to the next dose level only after short-term safety has been reviewed and subject to approval by a Safety Review Committee at the preceding dose level. |
| Cohort 2 - Medium dose | EXPERIMENTAL | The study is comprised of 3 dose cohorts and two dose escalation steps \[Cohort 1: 10 evaluable participants; Cohort 2: 10 evaluable participants; Cohort 3: 10 evaluable participants\]. Participants will be recruited to the next dose level only after short-term safety has been reviewed and subject to approval by a Safety Review Committee at the preceding dose level. |
| Cohort 3 - High dose | EXPERIMENTAL | The study is comprised of 3 dose cohorts and two dose escalation steps \[Cohort 1: 10 evaluable participants; Cohort 2: 10 evaluable participants; Cohort 3: 10 evaluable participants\]. Participants will be recruited to the next dose level only after short-term safety has been reviewed and subject to approval by a Safety Review Committee at the preceding dose level. |
| Name | Type | Description |
|---|---|---|
| BAX 826 | BIOLOGICAL | - |
| Octocog alfa | BIOLOGICAL | - |
Inclusion Criteria: 1. Previously treated male participants aged 18 to 65 years (inclusive) at the time of screening 2. Diagnosis of severe hemophilia A (Factor VIII level \<1%) 3. Previously treated with FVIII concentrates for ≥150 documented Exposure Days (EDs) 4. Karnofsky performance score of ≥...
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 |
BAX 826 is an investigational monoclonal antibody being developed for the treatment of hemophilia A, a bleeding disorder. It is in Phase 1 clinical development and is not approved for any use. Takeda Pharmaceutical Company Limited is the developer.
BAX 826 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is the sponsor of the clinical program evaluating the monoclonal antibody in hemophilia A.
BAX 826 is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA or any other regulatory agency. One Phase 1 trial has been completed, and no trials are currently active.
BAX 826 has been studied in one Phase 1 trial, NCT02716194, titled the BAX 826 Dose-Escalation Safety Study. The trial enrolled 40 male participants aged 18 years and older with hemophilia A across sites in Bulgaria, Germany, Hungary, Italy, Netherlands, Poland, Russia, Spain, and the United Kingdom. It is completed.
BAX 826 is a monoclonal antibody. It is being developed as an investigational therapy for hemophilia A, a condition in which blood does not clot properly. The clinical program evaluated dose escalation for safety in adult male participants with hemophilia A.
No. BAX 826 is an investigational monoclonal antibody in Phase 1 development for hemophilia A and is not approved for marketing. Its only recorded clinical trial, NCT02716194, was a completed Phase 1 dose-escalation safety study that enrolled 40 participants.