Approval Probability
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ML Risk
Also known as ADX-629 (Open-label)
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 developed by Aldeyra Therapeutics, Inc. (ticker ALDX). It is being studied in several conditions, including alcohol associated hepatitis, atopic asthma, atopic dermatitis, chronic cough, COVID-19, and ethanol intoxication. It is a Phase 2 clinical-stage candidate and has not been approved by the FDA.
ADX-629 is being studied as a treatment for alcohol associated hepatitis. A completed Phase 2 trial, NCT06685692, evaluated the safety and efficacy of ADX-629 in subjects with alcohol associated hepatitis in the United States. The trial enrolled 4 participants aged 21 years and older and was conducted in the United States.
ADX-629 is developed by Aldeyra Therapeutics, Inc., which trades on the Nasdaq under the ticker ALDX. The company is the sponsor of the clinical program studying ADX-629 across multiple inflammatory and immune-related conditions, including alcohol associated hepatitis, atopic dermatitis, chronic cough, and ethanol intoxication.
ADX-629 is in Phase 2 clinical development. It is an investigational small molecule and has not been approved by the FDA. Completed studies include Phase 2 trials in alcohol associated hepatitis, atopic dermatitis, and chronic cough, as well as a Phase 1 trial in subjects with elevated ethanol levels.
ADX-629 has been studied in completed trials including NCT06685692 in alcohol associated hepatitis, NCT05717920 in atopic dermatitis, NCT05487404 in ethanol intoxication, and NCT05392192 in chronic cough. These trials were conducted in the United States. The chronic cough trial, NCT05392192, enrolled 51 participants, the largest of the group.
Yes, ADX-629 (Open-label) refers to the same investigational small molecule, ADX-629, developed by Aldeyra Therapeutics, Inc. (ticker ALDX). The open-label designation describes the trial design used in some of the completed studies, not a different drug candidate. Both names refer to the same Phase 2 asset.