Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as No other names
AUR101 · 2 trials · 2 indications
PASI-75; A higher proportion of patients reaching PASI-75 means betterment in higher proportion of patients
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% reduction from baseline PASI score). (Scores range from 0 (minimum) to 30 (maximum)); The PASI is a scoring system to evaluate the baseline and response of therapy in psoriasis. Regulators commonly accept PASI 75 for measuring primary response of psoriasis in patients with Psoriasis. PASI 75 is a binary outcome that indicates a 75% or greater improvement in PASI from baseline
| Arm | Type | Description |
|---|---|---|
| AUR101 400 mg PO BID | EXPERIMENTAL | Patients will receive AUR101 / placebo in double blind, double dummy manner |
| AUR101 200 mg PO BID | EXPERIMENTAL | Patients will receive AUR101 / placebo in double blind, double dummy manner |
| AUR101 400 mg PO QD | EXPERIMENTAL | Patients will receive AUR101 / placebo in double blind, double dummy manner |
| Placebo | PLACEBO_COMPARATOR | Patients will receive AUR101 / placebo in double blind, double dummy manner |
| Arm-1 400 mg BID | EXPERIMENTAL | 400 mg AUR101 twice daily |
| Arm-2 600 mg BID | EXPERIMENTAL | 600 mg AUR101 twice daily |
| Arm-3 - Matching Placebo BID | PLACEBO_COMPARATOR | Matching Placebo twice daily |
| Name | Type | Description |
|---|---|---|
| AUR101 | DRUG | Oral ROR-gamma inverse agonist |
| Placebo | DRUG | Placebo |
| Matching Placebo | DRUG | Drug-Placebo of AUR101 tablet |
Inclusion Criteria: 1. Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months before screening 2. Psoriasis of at least moderate severity, defined as PASI≥12 and involved BSA≥10 % at screening and Day 1 3. Static 5-point IGA modified \[mod\] 2011 scale of 3 or higher at s...
AUR101 is an investigational small molecule being developed for the treatment of chronic plaque-type psoriasis and plaque psoriasis. It is currently in Phase 2 clinical development and has been studied in patients with moderate-to-severe psoriasis.
AUR101 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with psoriasis.
AUR101 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed to evaluate its efficacy and safety in patients with psoriasis.
AUR101 has been studied in two completed Phase 2 clinical trials. The first trial, NCT04207801, enrolled 90 patients with chronic plaque-type psoriasis in India. The second trial, NCT04855721, enrolled 141 patients with plaque psoriasis in the United States.
AUR101 is a distinct investigational small molecule being developed by Dr. Reddy's Laboratories. It is not known to be the same as any other marketed drug. Its mechanism of action has not been publicly disclosed in the available clinical trial information.