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FDA provides development pathway for ATH434

NASDAQ:ATHE   ALTERITY THERAPEUTICS LIMITED
Alterity Therapeutics meeting with US FDA provides development pathway for ATH434

announce that it has received guidance from the US Food and Drug Administration (FDA) in relation to the development pathway for ATH434 (previously PBT434), the company's lead compound for the treatment of Multiple System Atrophy ( MSA ), a Parkinsonian disorder.

The company recently met with the FDA following the successful completion of its Phase 1 clinical trial last year and further data analysis. The pre-IND (Investigational New Drug) meeting was to obtain input on the clinical development plan for ATH434, including feedback on the Phase 2 study design.

Alterity reached agreement with the FDA on the non-clinical investigations required to support the Phase 2 study. In addition, the FDA agreed to key aspects of the Company's Phase 2 study design including the proposed patient population, safety monitoring plan, and strategy for evaluating drug exposure during the study.

Alterity reached agreement with the FDA on the non-clinical investigations required to support the Phase 2 study. In addition, the FDA agreed to key aspects of the Company's Phase 2 study design including the proposed patient population, safety monitoring plan, and strategy for evaluating drug exposure during the study.

https://www.benzinga.com/news/20/06/1645...

Alterity Therapeutics (NASDAQ:ATHE) is up 71% premarket after receiving FDA guidance on a development pathway for ATH434 (previously PBT434), the company's lead compound for the treatment of Multiple System Atrophy ( MSA ), a Parkinsonian disorder, including feedback on the design of a Phase 2 trial.

Alterity reached agreement with the agency on the non-clinical investigations required to support the mid-stage study, along with patient population, safety monitoring plan, and strategy for evaluating drug exposure during the trial.

The agency and Alterity will work together to develop an endpoint that is best suited for the MSA patients.

The company is also pursuing approvals in Europe and Australia.

https://seekingalpha.com/news/3587207-al...

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