Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADX-629 · 7 trials · 7 indications
Incidence and severity of treatment-emergent adverse events
Incidence and severity of AEs
Safety was assessed through serious adverse event collection.
The change from baseline for PASI score was assessed on a 0 to 72 scale (0 = none, 72 = maximum severity). Mixed model for repeated measures (MMRM) analysis was performed using change from baseline as the dependent variable, baseline as a covariate, and visit as a factor.
| Arm | Type | Description |
|---|---|---|
| ADX-629 (125 mg twice daily) | EXPERIMENTAL | - |
| ADX-629 (250 mg twice daily) | EXPERIMENTAL | - |
| ADX-629 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days. |
| ADX-629 250 mg administered orally twice daily (BID) for approximately 12 weeks. | EXPERIMENTAL | - |
| ADX-629 300 mg administered orally twice daily (BID) for up to 28 days. | EXPERIMENTAL | - |
| Placebo administered orally BID for up to 28 days. | PLACEBO_COMPARATOR | - |
| ADX-629, 600 mg administered orally twice daily (PO bid) for a minimum of 1 week | EXPERIMENTAL | - |
| Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week | PLACEBO_COMPARATOR | - |
| ADX-629 Oral Tablets | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ADX-629 | DRUG | 125 mg twice daily for 28 days |
| ADX-629 (Open-label) | DRUG | ADX-629 (250 mg) administered twice daily for 90 days |
| Placebo | DRUG | Subjects will be randomized to receive both ADX-629 and placebo in one of two treatment sequences: One group of subjects will receive ADX-629 during the 1st treatment period and matching placebo during the 2nd Treatment while subjects the other sequence/group will receive the matching placebo in the 1st treatment period and ADX-629 in the 2nd treatment period. |
Inclusion Criteria: * Adult ≥ 21 years old on the day of signing the informed consent form; * Clinical diagnosis of alcoholic hepatitis, based on clinical features and laboratory testing, confirmed by the Investigator at screening * Agreement to abstain from alcohol and utilize resources to cease a...
ADX-629 is an investigational small molecule being studied for multiple conditions, including ethanol intoxication, COVID-19, atopic dermatitis, chronic cough, atopic asthma, and alcohol hepatitis. It is developed by Aldeyra Therapeutics and is currently in Phase 2 clinical development.
ADX-629 is a small molecule, but its specific molecular target has not been disclosed. It is being evaluated for its safety and efficacy in several inflammatory and metabolic conditions, including chronic cough and atopic dermatitis.
ADX-629 is developed by Aldeyra Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALDX. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
ADX-629 is in Phase 2 clinical development. It has completed several trials, including a Phase 2 study for chronic cough and a Phase 1 study for ethanol intoxication. It is not yet approved by the FDA and remains investigational.
ADX-629 has completed four clinical trials: NCT04847544 for COVID-19 (Phase 2, 11 participants), NCT05392192 for chronic cough (Phase 2, 51 participants), NCT05487404 for ethanol intoxication (Phase 1, 26 participants), and NCT05717920 for atopic dermatitis (Phase 2, 8 participants). All trials were conducted in the United States.
No alternative names for ADX-629 have been reported. It is identified solely by its code name ADX-629 in clinical trials and by its developer, Aldeyra Therapeutics.