Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SEPO · 1 trial · 1 indication
Hb levels measured from Weeks 9 through 13 will be averaged in order to provide a single measure for comparison to the baseline Hb levels.
| Arm | Type | Description |
|---|---|---|
| Roxadustat | EXPERIMENTAL | Participants will receive roxadustat, administered orally 3 times per week (TIW) for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be based on the participant's weight group. The maximum dose for individual participants may not exceed 3.5 milligrams (mg)/kilogram (kg) or 400 mg TIW whichever is lower. |
| SEPO® | ACTIVE_COMPARATOR | Participants will receive SEPO®, injected subcutaneously TIW for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be 150 international units (IU)/kg subcutaneously TIW. |
| Name | Type | Description |
|---|---|---|
| SEPO® | DRUG | SEPO® will be administered per dose and schedule specified in the arm description. |
| Roxadustat | DRUG | Roxadustat will be administered per dose and schedule specified in the arm description. |
Key Inclusion Criteria: * Diagnosis of non-myeloid malignancy, by histological or cytological confirmation. * Anemia related to myelosuppressive chemotherapy, defined as Hb ≤100 g/L at screening with documented participant's Hb level decrease ≥10 g/L after the initiation of chemotherapy as judged b...
SEPO is an investigational small molecule being developed for the treatment of chemotherapy induced anemia, a condition of low red blood cell counts that can occur in patients receiving chemotherapy. It is currently in Phase 3 clinical development.
SEPO is being developed by Kyntra Bio, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol KYNB.
SEPO is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 clinical trial evaluating SEPO for chemotherapy induced anemia has been completed.
SEPO has been studied in a Phase 3 clinical trial registered as NCT05301715. This trial evaluated the efficacy and safety of SEPO for the treatment of anemia in participants receiving chemotherapy for non-myeloid malignancies. The trial enrolled 159 participants in China and has been completed.
SEPO is the drug name used by Kyntra Bio, Inc. for the investigational treatment. In the clinical trial NCT05301715, the study title refers to roxadustat, which is the active pharmaceutical ingredient being evaluated for chemotherapy induced anemia.