While keep­ing eye on snap NASH OK, In­ven­ti­va tests out al­ter­na­tive PhI­II path

As promis­ing late-stage da­ta rein­vig­o­rate the en­thu­si­asm for NASH drugs af­ter years of set­backs, one play­er is chang­ing up its Phase III plans to cap­i­tal­ize on what it sees as a new reg­u­la­to­ry ap­proach at the FDA.

In­ven­ti­va, which kicked off its Phase III NA­TiV3 study for lan­i­fi­bra­nor in 2021, had orig­i­nal­ly de­signed a two-part study where part one would sup­port ac­cel­er­at­ed ap­proval with da­ta from 900 pa­tients and part two would fol­low 2,000 pa­tients for up to sev­en years. While part one will con­tin­ue as planned, In­ven­ti­va is now re­plac­ing part two with a new, sep­a­rate Phase III tri­al that will en­roll around 800 pa­tients and last for about three years.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER