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Also known as BAX 335
AskBio009 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| AskBio009 Dose Escalation | EXPERIMENTAL | Single Dose of a Self-Complementing Optimized Adeno-associated Virus (AAV) Serotype 8 Factor IX Gene Therapy |
| Name | Type | Description |
|---|---|---|
| AskBio009 | BIOLOGICAL | Single dose IV injection |
Inclusion Criteria: * Males age 18-75 years, inclusive * Established hemophilia B with ≥3 hemorrhages per year requiring treatment with exogenous FIX OR use of FIX prophylaxis because of history of frequent bleeding episodes * Plasma FIX activity ≤2% (\<1% for first cohort; then per protocol) * Neg...
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 |
AskBio009 is an investigational monoclonal antibody being developed by Takeda Pharmaceutical Company Limited for the treatment of Hemophilia B. It is in Phase 1 clinical development and is designed to target factor IX (FIX). It has not been approved by the FDA and remains an experimental therapy under study.
AskBio009 is being studied for use in Hemophilia B, a bleeding disorder. The single Phase 1 trial enrolled 30 adult male participants with Hemophilia B in the United States. Because the trial is an open-label, single ascending dose study, AskBio009 is still investigational and is not an approved treatment for Hemophilia B.
AskBio009 targets factor IX, also known as FIX. Factor IX is a clotting protein that is deficient or defective in people with Hemophilia B. By binding to FIX, the monoclonal antibody is intended to interact with this component of the coagulation pathway, though the clinical significance of this targeting is still being evaluated in Phase 1 testing.
AskBio009 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the Phase 1 clinical program evaluating the monoclonal antibody in adults with Hemophilia B. The company holds the development rights for this investigational asset.
AskBio009 is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The Phase 1 program is designed to assess the drug in adults with Hemophilia B, and further development would depend on the results of this early-stage study.
AskBio009 is being evaluated in one clinical trial, NCT01687608, titled Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia B. The trial is Phase 1, active but not recruiting, and enrolled 30 adult male participants with Hemophilia B in the United States.