Development

REDNVIA terminates Phase II/III trial of DPP-4 inhibitor evogliptin in aortic stenosis

A randomized, placebo-controlled trial evaluating the DPP-4 inhibitor evogliptin (DA-1229) as a potential therapy for calcific aortic valve disease has been...

REDNVIA terminates Phase II/III trial of DPP-4 inhibitor evogliptin in aortic stenosis

A randomized Phase II/III trial evaluating evogliptin (DA-1229) as a potential treatment for calcific aortic valve disease has been terminated after enrolling 486 patients, according to an update to ClinicalTrials.gov. The registry states that sponsor REDNVIA Co., Ltd. terminated the EVOID-AS study due to a business decision and explicitly notes that no safety issues influenced the decision. No separate public announcement explaining the termination was identified.

EVOID-AS (NCT05143177) was an adaptive, randomized, double-blind, placebo-controlled Phase II/III study evaluating whether evogliptin could slow disease progression in patients with mild to moderate aortic stenosis. The trial had reached an actual enrollment of 486 patients before termination. Evogliptin is a DPP-4 inhibitor originally developed by Dong-A ST and marketed as Suganon for type 2 diabetes in South Korea and other markets.

The study was investigating whether DPP-4 inhibition could be repurposed to modify the progression of calcific aortic valve disease, for which no drug therapy has been established to prevent or slow progression. Patients with severe symptomatic disease are instead treated with surgical or transcatheter aortic valve replacement, making pharmacological intervention earlier in the disease course a longstanding development goal.

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The registry does not provide further detail on the business considerations behind the termination or indicate whether development of evogliptin in aortic stenosis will continue through another study. No other active ClinicalTrials.gov studies evaluating evogliptin in calcific aortic valve disease were identified.


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