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Eidos Therapeutics Initiates ATTRibute-CM, a Phase 3 Study of AG10 in ATTR-CM with Registrational 12-month Endpoint
Eidos Therapeutics, Inc., today announced the initiation and design of its pivotal global Phase 3 trial (ATTRibute-CM) of AG10 in patients with Transthyretin (TTR) Amyloid Cardiomyopathy (ATTR-CM). The design of the ATTRibute-CM study, which incorporates feedback from FDA, includes two potentially registrational endpoints. In Part A, benefit in change from baseline in 6-minute walk distance (6MWD) will be evaluated at 12 months, potentially accelerating the time to registration. In Part B, reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations will be evaluated at 30 months.
“ATTRibute-CM aims to generate registrational evidence that AG10 provides meaningful benefit to ATTR-CM patients. The trial is designed to evaluate preservation of function and quality of life on an accelerated timeframe in addition to evaluating longer-term benefit on mortality and cardiovascular-related hospitalizations,” said Jonathan Fox, MD, PhD, president and chief medical officer of Eidos.
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