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Also known as Dexamethasone 21-phosphate
Dex 21-P · 1 trial · 1 indication
Patients were considered responder if, at the EoS, one of the following occurred: * Disease remission (Powell Tuck index ≤ 3 or CDAI \< 150) and withdrawal of oral steroids therapy from at least the second treatment procedure; * Disease marked improvement vs basal conditions (at least 5 point decrease in Powell Tuck or 150 point decrease in CDAI score) and withdrawal of oral steroids therapy from at least the second treatment procedure. The Powell-Tuck index was calculated by adding the subscores given by 7 items. A total score \< 10 indicated a mild activity of the UC, and a total score \>14 a severe one. The higher the score the worse the outcome. Crohn Disease Activity Index (CDAI) was a tool that combines subjective parameters, with objectives parameters. The score given to each parameter was inserted in an algorithm which provided the final Index value. A moderate CD showed a CDAI score between 220 and 450, while a CDAI \> 450 was an activity index indicating a severe disease.
| Arm | Type | Description |
|---|---|---|
| Dex 21-P | EXPERIMENTAL | In this arm a dose of 20 ml of Dex 2-P solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously loaded with Dex 21-P. |
| Placebo | PLACEBO_COMPARATOR | In this arm placebo solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously NOT loaded with Dex21-P. |
| Name | Type | Description |
|---|---|---|
| Dex 21-P | DRUG | At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter. |
| Placebo | DRUG | Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P |
Inclusion Criteria: 1. More than 18 years of age 2. Patients suffering from one of the following chronic inflammatory intestinal disease: * Steroid-dependent Chron's Disease or Ulcerative Colitis following ECCO definition or mild-moderate active UC ( Powell Tuck between 3 and 14- an index of 14...
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Dex 21-P is an investigational small molecule being developed for the treatment of ulcerative colitis, a form of inflammatory bowel disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Dex 21-P is a small molecule that delivers dexamethasone 21-phosphate, a corticosteroid, using erythrocyte-mediated delivery. This approach aims to target the drug to inflamed tissues in the gastrointestinal tract, potentially reducing systemic side effects compared to standard corticosteroids.
Dex 21-P is being developed by Quince Therapeutics, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol QNCX. The company is advancing the drug through clinical trials for ulcerative colitis.
Dex 21-P is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug, meaning it has not yet been approved for commercial use.
Dex 21-P has been studied in a completed Phase 2 trial with the identifier NCT01171807, titled "Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis." The trial enrolled 33 participants in Italy and was placebo-controlled.
Dex 21-P is a formulation of dexamethasone 21-phosphate, a corticosteroid, delivered via erythrocyte-mediated technology. The drug name Dex 21-P refers to this specific delivery approach, which is designed to enhance the drug's targeting to inflamed tissues in ulcerative colitis.