Alterity Therapeutics Ltd. (NASDAQ: ATHE) says it has received an update from the U.S. Food and Drug Administration (FDA) regarding its Parkinson’s treatment. Shareholders were happy, as the stock more than doubled in Tuesday’s session.
The FDA gave guidance on the development pathway for ATH434 (previously PBT434), the company’s lead compound for the treatment of multiple system atrophy (MSA), a Parkinsonian disorder.
Alterity 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.
Ultimately, the company reached an agreement with the FDA on the nonclinical investigations required to support the Phase 2 study. Additionally, the FDA agreed to key aspects of the Phase 2 study design, including the proposed patient population, safety monitoring plan and strategy for evaluating drug exposure during the study.
Currently there are no approved treatments for MSA. As a result, there is no regulatory precedent regarding accepted efficacy endpoints. So, the FDA and Alterity will work together to develop an endpoint that is best suited for the MSA patients to be studied.
Separate from Alterity’s U.S. strategy, the company also is pursuing a regulatory pathway in Europe and Australia.
Alterity stock traded up about 118% to $1.27 on Tuesday, in a 52-week range of $0.28 to $1.63.
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