On Friday, BridgeBio Pharma, Inc. ( BBIO )  presented a post-hoc analysis evaluating the effect of acoramidis on the composite endpoint of all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVH) events in its Phase 3 ATTRibute-CM study in ATTR-CM.

The data were shared at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2024.

Also Read: BridgeBio Pharma Seeks Partner To Develop Gene Therapy For Inherited Condition.

ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis.

The analysis included:

A 42% reduction in composite ACM and recurrent CVH events at 30 months was observed with acoramidis treatment compared to placebo by applying a negative binomial regression model (post-hoc) (p=0.0005).

A 42% reduction in ACM and recurrent CVH events per patient was observed over 30 months with acoramidis treatment compared to placebo.

A 30.5% hazard reduction in ACM and recurrent CVH events at 30 months was observed with acoramidis treatment compared to placebo by applying the Andersen-Gill model (post-hoc) (p=0.0008).

“This post-hoc analysis provides further evidence that near-complete TTR stabilization with acoramidis can improve clinical outcomes for patients with ATTR-CM. The reduction of hospitalizations and all-cause mortality seen in ATTRibute-CM heightens the case for acoramidis as a first-line therapy, given its potential to improve the overall quality of life for patients,” said Daniel Judge, M.D., professor of medicine and cardiology at the Medical University of South Carolina.

Transthyretin amyloidosis (ATTR-CM) occurs when the liver produces faulty transthyretin (TTR) proteins. Clumps of these abnormal proteins (fibrils) build up in the heart’s main pumping chamber.

Based on the results from ATTRibute-CM, BridgeBio submitted an FDA marketing application, which has been accepted with a PDUFA action date of November 29, 2024, and a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025.

In August, BridgeBio Pharma ( BBIO ) presented additional data from an analysis of its Phase 3 ATTRibute-CM and open-label extension study of acoramidis in ATTR-CM at the European Society of Cardiology 2024.

Price Action: BBIO stock is up 2.39% at $25.54 at last check Monday.

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