Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DUR-928 Topical Solution
DUR-928 · 3 trials · 2 indications
The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe
The Lille score predicts response of AH subjects to treatment with glucocorticoids, such as prednisolone. This score is based on age, serum albumin, creatinine, PT, and the difference in bilirubin between pre-treatment and Day 7 post-treatment. The Lille score ranges from 0.01 to 1.00. A score \>0.45 predicts a higher risk of death and the recommendation to stop steroid administration. Lille Score = Exp(-R)/(1 + Exp(-R)) Where: R = \[3.19 - (0.101 x Age in years)\] + (1.47 x Albumin in g/dL) + \[0.28215 x (Bilirubin initial - Bilirubin day 7 in mg/dL)\] - (0.206 x Creatinine in mg/dL) - (0.11115 x Bilirubin initial in mg/dL) - (0.0096 x PT in seconds) NOTE: When calculating Lille, use "baseline" values for ALL parameters EXCEPT bilirubin at Day 7. Baseline would be the Day 1 Pre-dose sample result, if available. If not available, then use the Screening sample result.
The MELD score at enrollment is a good predictor for AH patient prognosis. Laboratory values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. The MELD score ranges from 6.0 to 40.0 (capped) with a higher score predicting a higher risk of death. A sequentially improving MELD score is associated with a better chance of recovery. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1.
The MELD Score %change from baseline is a %change between 2 time points, baseline and value at a specific time point (Day 7 or Day 28). MELD score is a good predictor of outcome. A declining MELD score suggests disease improvement. Lab values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1.
| Arm | Type | Description |
|---|---|---|
| DUR-928 (larsucosterol, 30 mg) | EXPERIMENTAL | - |
| DUR-928 (larsucosterol, 90 mg) | EXPERIMENTAL | - |
| (Placebo) Sterile Water for Injection | PLACEBO_COMPARATOR | - |
| DUR-928 Topical Solution | EXPERIMENTAL | DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. |
| Vehicle Topical Solution | PLACEBO_COMPARATOR | Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. |
| Part A (Moderate AH) DUR-928 30 mg | EXPERIMENTAL | Lowest dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg |
| Part A (Moderate AH) DUR-928 90 mg | EXPERIMENTAL | Middle dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg |
| Part A (Moderate AH) DUR-928 150 mg | EXPERIMENTAL | Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg |
| Part B (Severe AH) DUR-928 30 mg | EXPERIMENTAL | Lowest dose of dose escalation arms: 30mg, 90 mg and 150 mg |
| Part B (Severe AH) DUR-928 90 mg | EXPERIMENTAL | Middle dose of dose escalation arms: 30mg, 90 mg and 150 mg |
| Part B (Severe AH) DUR-928 150 mg | EXPERIMENTAL | Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg |
| Name | Type | Description |
|---|---|---|
| DUR-928 30 mg | DRUG | IV infusion |
| DUR-928 90 mg | DRUG | IV infusion |
| Placebo+ Standard of Care (SOC) | DRUG | IV infusion |
| DUR-928 Topical Solution | DRUG | Topical solution containing active drug |
| Vehicle Topical Solution | DRUG | Topical solution containing no active drug |
| DUR-928 150 mg | DRUG | Highest dose of 3 dose escalation arms. |
Inclusion Criteria: 1. Able to provide written informed consent (either from subject or subject's legally acceptable representative). 2. Onset of jaundice within prior 8 weeks. 3. Average daily consumption of \>40 (females) or \>60 (males) grams of alcohol for 6 months or longer, with \< 8 weeks of...
DUR-928 is an investigational small molecule developed by DURECT Corporation for the treatment of alcoholic hepatitis and plaque psoriasis. It is a Phase 2 clinical-stage candidate that has been studied in randomized, double-blind, placebo-controlled trials. DUR-928 is also known as DUR-928 30 mg and DUR-928 Topical Solution.
DUR-928 is being developed for two indications: alcoholic hepatitis and plaque psoriasis. The alcoholic hepatitis program has been studied in Phase 2 trials, including a Phase 2b study, while the plaque psoriasis program has been evaluated with a topical solution formulation in a Phase 2 trial.
DUR-928 targets DNA methyltransferases, a class of enzymes. By acting on these enzymes, DUR-928 is designed to modulate epigenetic regulation. This mechanism distinguishes it from conventional therapies and supports its investigation in both liver and skin conditions.
DUR-928 is developed by DURECT Corporation, which trades on the Nasdaq under the ticker DRRX. The company is responsible for the clinical development of DUR-928 across its alcoholic hepatitis and plaque psoriasis programs.
DUR-928 is in Phase 2 clinical development. It has completed Phase 2 trials in alcoholic hepatitis and plaque psoriasis, including a Phase 2b study in alcoholic hepatitis. DUR-928 is investigational and has not been approved by the FDA for any indication.
DUR-928 has been studied in completed Phase 2 trials. These include NCT04563026, a Phase 2b study in alcoholic hepatitis with 307 participants, NCT03837743, a Phase 2 trial in plaque psoriasis with 25 participants, and NCT03432260, a Phase 2 study in alcoholic hepatitis with 19 participants.