BridgeBio Pharma (BBIO) on Monday reported data from its phase 3 ATTRibute-CM trial showing that an early, sustained increase in serum transthyretin levels is linked to improved survival in patients treated with acoramidis for transthyretin amyloid cardiomyopathy.

According to the data, patients treated with acoramidis saw an average increase of 9.1 milligrams per deciliter in serum TTR levels within 28 days, a rise that was maintained over the 30-month study period. Statistical models predicted that for every 5-mg/dL increase in TTR, the risk of mortality dropped by up to 31.6%, the biopharmaceutical company said.

The study found that an early increase in serum TTR levels was independently linked to reduced all-cause mortality, regardless of baseline characteristics, while no comparable response was observed in patients receiving placebo, the company said.

A causal mediation analysis further suggested that the survival benefit of acoramidis was fully explained by this TTR increase, reinforcing the biomarker's role as a key indicator of treatment success.

Acoramidis is approved under the name Attruby by the FDA and as BEYONTTRA by regulatory agencies in Europe, Japan, and the UK, with all approvals highlighting its ability to nearly completely stabilize TTR, the company said.

Shares of BridgeBio Pharma were down more than 2% in recent Monday trading.

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