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Also known as ATH434 dose level 1
ATH434 · 3 trials · 1 indication
All AEs will be reviewed at every participant contact and documented in the CRF. All SAEs will be reported within 24 hours of awareness in accordance with local regulatory requirements.
Clinical laboratory parameters include hematology and blood chemistry panels.
Vital signs include blood pressure, pulse, temperature, and respiration rate.
Total duration of treatment with investigational product per participant.
Total cumulative dose of investigational product administered per participant.
| Arm | Type | Description |
|---|---|---|
| ATH434 75mg BID | EXPERIMENTAL | Participants who completed the prior ATH434-201 Phase 2 trial will receive ATH434 75 mg orally twice daily (BID). Treatment consists of an initial 12-month treatment phase, followed by an ongoing extension phase based on investigator assessment of continued clinical benefit, safety, and tolerability |
| ATH434 | EXPERIMENTAL | - |
| ATH434 Arm 1 | EXPERIMENTAL | - |
| ATH434 Arm 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ATH434 | DRUG | ATH434 75 mg tablets administered orally twice daily (BID). |
| ATH434 dose level 1 | DRUG | ATH434 taken BID |
| ATH434 dose level 2 | DRUG | ATH434 taken BID |
| Placebo | DRUG | Placebo taken BID |
Inclusion Criteria: * Completed Alterity protocol ATH434-201. * Expected to benefit from treatment from treatment with ATH434, in the opinion of the Investigator. Exclusion Criteria: * Discontinued prior ATH434 treatment (ATH434-201) for any reason. * Significant medical or psychiatric condition ...
ATH434 is an investigational small molecule being developed for the treatment of Multiple System Atrophy (MSA), a rare neurodegenerative disorder. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug has received Orphan Drug and Fast Track designations from the FDA.
ATH434 is a small molecule designed to target pathological processes in Multiple System Atrophy (MSA). While the specific molecular target is not disclosed in available information, it is being studied for its potential to modify the disease course. The drug is in Phase 2 clinical trials for MSA.
ATH434 is being developed by Alterity Therapeutics Limited, a biopharmaceutical company listed on the NASDAQ under the ticker symbol ATHE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Multiple System Atrophy (MSA).
ATH434 is currently in Phase 2 clinical development for Multiple System Atrophy (MSA). It is an investigational drug that has not been approved by regulatory authorities. The FDA has granted it Orphan Drug and Fast Track designations, reflecting the serious nature of the condition it targets.
ATH434 has been studied in two clinical trials. The first, NCT05864365, was a completed Phase 2 biomarker study in 10 participants with Multiple System Atrophy (MSA) in the United States. The second, NCT07729852, is a Phase 2 open-label access study for patients who completed the first trial, enrolling 5 participants in France.
ATH434 is the primary name for this investigational drug. No alternative names have been reported in the available clinical trial information. It is being developed by Alterity Therapeutics Limited for the treatment of Multiple System Atrophy (MSA) and is currently in Phase 2 trials.