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Also known as ATH434 dose level 1, PBT434
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 being developed for the treatment of Multiple System Atrophy, a rare neurological disorder. It is an investigational small molecule and has not been approved for any indication. Development is focused on the Multiple System Atrophy patient population, and the program holds Orphan Drug and Fast Track designations from the FDA.
ATH434 is developed by Alterity Therapeutics Limited, which trades under the ticker ATHE. The company is the sponsor of the clinical program evaluating ATH434 in Multiple System Atrophy, including the Phase 2 studies conducted across the United States, Australia, France, Italy, New Zealand, and the United Kingdom.
ATH434 is in Phase 2 clinical development for Multiple System Atrophy. Three Phase 2 trials have been conducted or are ongoing, with two completed and one currently enrolling by invitation. The program has enrolled a total of 94 participants across these studies and remains investigational.
ATH434 has been studied in three Phase 2 trials. NCT05109091 was a placebo-controlled study of ATH434 in participants with Multiple System Atrophy that enrolled 77 patients. NCT05864365 was a biomarker study in 10 participants, and NCT07729852 is an open-label access study in France for patients who completed ATH434-201.
ATH434 dose level 1 refers to a specific dose level within the ATH434 clinical program rather than a separate drug. ATH434 is the compound itself, a small molecule being developed by Alterity Therapeutics for Multiple System Atrophy, and dose level 1 is one of the doses evaluated in its Phase 2 trials.
ATH434 has received both Orphan Drug and Fast Track designations from the FDA for its development in Multiple System Atrophy. These designations support the ongoing Phase 2 program, which includes randomized, double-blind, placebo-controlled trials. ATH434 remains an investigational therapy and is not approved for commercial use.