The findings indicated that its PreciSION CF Phase 2a trial assessing SION-719 missed its key primary activity target, leading the company to halt further advancement of SION-719 as an add-on therapy.
SION-719 Fails Primary Endpoint In Phase 2a Trial
In the PreciSION CF Phase 2a proof-of-concept study, SION-719 was evaluated in combination with Trikafta (elexacaftor/tezacaftor/ivacaftor) among CF participants.
The trial yielded a -1.0 mmol/L mean placebo-adjusted change in sweat chloride (p=0.7), falling short of its activity target.
Sionna highlighted potential confounders, such as unexpected variability in individual sweat chloride levels and differences in Trikafta exposure across the SION-719 and placebo periods.
