Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Recombinant human erythropoietin-α [rHuEPO-α]
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 developed by Kyntra Bio, Inc. for chemotherapy induced anemia in patients with non-myeloid malignancies. It is being studied in a Phase 3 clinical program and has not been approved by the FDA. SEPO is also written as SEPO®.
SEPO is being developed for the treatment of chemotherapy induced anemia in patients receiving chemotherapy for non-myeloid malignancies. The condition involves low red blood cell counts caused by chemotherapy. SEPO is investigational and is not approved for this or any other use.
SEPO is developed by Kyntra Bio, Inc., which trades under the ticker KYNB. The company is the sponsor of the clinical program evaluating SEPO in chemotherapy induced anemia. Kyntra Bio is studying SEPO as a small molecule therapy in the hematology therapeutic area.
SEPO is in Phase 3 clinical development. Its single registered trial, NCT05301517, is a completed Phase 3 study. SEPO is investigational and has not received FDA approval. No active trials of SEPO are currently listed.
SEPO has been evaluated in one clinical trial, NCT05301517, titled A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies. The Phase 3 trial enrolled 159 participants in China, was active controlled and randomized, and is now completed.
Yes, SEPO and SEPO® refer to the same investigational drug candidate from Kyntra Bio, Inc. SEPO® is the registered name styling of SEPO. Both names point to the same small molecule being studied in Phase 3 for chemotherapy induced anemia.