Alternative Endpoints in Phase III Trials Don’t Always Mean Boosts to OS, QOL
CHICAGO — Late-phase trials that showed superiority for an experimental intervention on a surrogate endpoint did not necessarily lead to improvements in overall survival (OS) or quality of life (QOL), according to a meta-epidemiologic analysis. Alexander Dean Sherry, MD of the MD Anderson Cancer Center in Houston, and colleagues evaluated 791 randomized controlled trials (RCTs) […]
NASH Drug Candidate Comes With ‘Serious Risks,’ Says FDA Staff
While citing obeticholic acid’s (Ocaliva) modest effect on a single surrogate endpoint for nonalcoholic steatohepatitis (NASH), FDA staff members raised “substantial concerns” over the frequency of drug-induced liver injury, along with a litany of other safety concerns. The assessment dims the prospect of regulatory approval as the oral drug makes an iffy second bid to […]
Want Us to Find the Fountain of Youth? Give Us Endpoints, Scientists Say
WASHINGTON — Better surrogate endpoints are needed to help patients benefit from anti-aging therapies, experts told a House committee Thursday. “It would be important to develop different metrics of measuring success,” said Steve Horvath, PhD, principal investigator at Altos Labs, a San Francisco-based biotechnology company focused on cellular rejuvenation programming. “Imagine that you have a […]