Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EryDex System
DSP loaded RBC using EryDex System · 1 trial · 1 indication
The 24-hour recovery of autologous RBCs loaded with DSP or sham using the EDS will be greater than 75% with 95% confidence. For RBC kinetics and recovery will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.
For RBC T50 will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.
| Arm | Type | Description |
|---|---|---|
| DSP loaded RBC using EryDex System | ACTIVE_COMPARATOR | Autologous RBC loaded with DSP using the EDS process, and treated RBC are infused to the subject. |
| Sham treated RBC using the EryDex System | SHAM_COMPARATOR | Autologous RBC are treated with buffer using the EDS process, and treated RBC are infused to the subject. |
| Name | Type | Description |
|---|---|---|
| DSP loaded RBC using EryDex System | DRUG | Intravenous infusion of 10 mg DSP encapsulated in autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC. |
| Sham treated RBC using the EryDex System | DRUG | Intravenous infusion of sham treated autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC. |
Inclusion Criteria: * If female of childbearing potential\*, the subject agrees not to donate ova and to use one of 4 methods of contraception from the time of signing the informed consent until 2 months after infusion * If male, the subject agrees to not donate sperm and to use barrier contracepti...
DSP loaded RBC using EryDex System is an investigational small molecule therapy developed by Quince Therapeutics, Inc. (ticker QNCX). It combines dexamethasone sodium phosphate (DSP) with red blood cells using the company's EryDex delivery system. The product is in Phase 1 clinical development, and its specific therapeutic indication has not been disclosed.
DSP loaded RBC using EryDex System is being developed by Quince Therapeutics, Inc., which trades under the ticker QNCX. Quince Therapeutics is the company responsible for the EryDex System technology used to load dexamethasone sodium phosphate into red blood cells.
DSP loaded RBC using EryDex System is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
DSP loaded RBC using EryDex System has been evaluated in one completed Phase 1 trial, NCT02380924, titled Recovery and Survival of EryDex in Non-patient Volunteers. The trial enrolled 10 healthy adult volunteers in the United States, was randomized and active-controlled, and did not use double blinding.
The therapeutic indication for DSP loaded RBC using EryDex System has not been disclosed. The only completed clinical trial, NCT02380924, studied the recovery and survival of EryDex in healthy non-patient volunteers rather than in a patient population, so no disease indication has been publicly specified for this asset.