ATHE - Alterity wins Italian nod to study lead asset in Parkinsonian disorder
Australian biotech Alterity Therapeutics (NASDAQ:ATHE) announced on Thursday that the authorities in Italy cleared a Phase 2 trial for its lead drug candidate ATH434 in multiple system atrophy (MSA), a rare Parkinsonian disorder. The randomized, double-blind study will be designed to evaluate one of two doses of ATH434 or placebo in patients with early-stage MSA. The trial is expected to recruit approximately 60 adult patients, and after 12 months of treatment, the company expects to detect changes in efficacy endpoints to develop a study protocol for a definitive Phase 3 study. “With our trial now open for enrolment in New Zealand and regulatory authorizations in the UK and Italy, we are focused on opening study sites in these regions and expanding access to other countries throughout the year," Chief Executive David Stamler said. In November, Alterity (ATHE) shares surged in reaction to publication of preclinical data indicating the potential of
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Alterity wins Italian nod to study lead asset in Parkinsonian disorder