BridgeBio Pharma (BBIO) said Monday that new exploratory cardiac data from the 12-month interim analysis of Fortify phase 3 study of oral BBP-418 showed individuals with limb-girdle muscular dystrophy type 2I/R9 reaching normal or near-normal levels on disease markers.

Data demonstrated that all participants treated with BBP-418 returned to the normal range for HS troponin l, a blood test used to detect injury to heart muscle, by month 12, compared with 40% for the placebo arm, the company said.

Additionally, 54% of participants treated with BBP-418 had stable or improved left ventricular ejection fraction, a measure of how much blood is being pushed out by the heart's main chamber with each beat, at month 12 versus 25% for those on placebo, BridgeBio Pharma said.

BBP-418 is currently under the US Food and Drug Administration's priority review with a Prescription Drug User Fee Act target action date of Nov. 27, according to a statement.