Alterity Therapeutics (ASX:ATH) granted FDA approval for MSA treatment drug

• Alterity Therapeutics (ATH) granted approval for its treatment for multiple system atrophy
• The approval will allow the company to evaluate its drug in individuals with the rare and highly debilitating Parkinsonian disorder via a phase two clinical trial in the US
• The company is expecting to enrol 60 adult patients, who will each receive one of two dose levels of ATH434 or placebo
• Patients will receive treatment for 12 months, which will provide an opportunity to detect changes in efficacy endpoints to optimise design of a definitive Phase 3 study
• Alterity Therapeutics is up 12.5 per cent, trading at 1.8 cents at 10:57 am AEST

Alterity Therapeutics (ATH) has received FDA approval for its treatment for multiple system atrophy (MSA).

The biotechnology company received approval of its investigational new drug application by the US Food and Drug Administration (FDA) to allow evaluation of ATH434 in individuals with the rare and highly debilitating Parkinsonian disorder.

The approval authorizes Alterity to conducts its phase two clinical trial in the United States.

The phase two clinical trial is a placebo-controlled investigation of ATH434 in patients with early-stage MSA.

Patients will be connected to sensors that will evaluate motor parameters that are important in patients with MSA.  

The company is expecting to enrol 60 adult patients to receive one of two dose levels of ATH434 or placebo. Patients will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimise design of a definitive Phase 3 study.

“The FDA’s acceptance of our IND to study ATH434 in individuals with MSA is another important milestone in the development of a much-needed treatment for this devastating condition,” CEO David Stamler said.

“We have been working closely with leading MSA physicians in the US and expect to open our first clinical trial site for enrolment in the fourth quarter of this year.”

“This complements our ongoing progress in other regions around the world.”

Alterity Therapeutics was up 12.5 per cent, trading at 1.8 cents at 10:57 am AEST.