Alterity Therapeutics Ltd ATHE shares are trading sharply lower by 14.29% to $0.48, reversing following earlier strength, after the company announced the approval of its Investigational New Drug application by the FDA to allow evaluation of ATH434 in individuals with Multiple System Atrophy.
Alterity Therapeutics says the Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA.
The study will explore the effect of ATH434 treatment on neuroimaging and protein biomarkers, such as excess brain iron and aggregating α-synuclein, which are important contributors to MSA pathology.
Why it Matters
"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," said David Stamler, M.D., Chief Executive Officer, Alterity.
"We have been working closely with leading MSA physicians in the U.S. 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."
According to data from Benzinga Pro, Alterity Therapeutics has a 52-week high of $1.39 and a 52-week low of $0.42.
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