BridgeBio Pharma's Acoramidis Shows Competitive Edge Against Pfizer's Tafamidisa In Lucrative But Competitive ATTR-CM Market

On Monday, BridgeBio Pharma, Inc. BBIO presented initial outcomes from the ATTRibute-CM open-label extension (OLE) study of acoramidis in ATTR-CM at the American Heart Association Scientific Sessions.

ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis, an investigational small-molecule stabilizer of transthyretin (TTR) gene.

Also Read: BridgeBio Pharma’s Lead Candidate Cuts Mortality, Related Hospitalizations In Patients With Certain Type Of Heart Disease

The OLE study involves 330 participants who completed the 30-month ATTRibute-CM Phase 3 study.

Key initial results from the OLE study show that continuous treatment with acoramidis led to:

• A confirmed sustained improvement relative to placebo in time to the first event ( cardiovascular-related hospitalizations (CVH) or All-Cause Mortality (ACM)) starting at Month 3 in ATTRibute-CM
• A statistically significant reduction in ACM alone of 36% by Month 36 (p=0.009) and 34% by Month 42 (p=0.006).
• A significant reduction of composite ACM and CVH by 46% at Month 36 and 48% at Month 42, building upon the previously presented 42% reduction at Month 30 in ATTRibute-CM.
• Acoramidis continues to be well tolerated, with no new clinically significant safety signals identified in this long-term evaluation.

The OLE data build on previously reported results from ATTRibute-CM in which acoramidis demonstrated clinically important treatment effects on mortality, CVH, and quality of life, further supporting that greater transthyretin (TTR) stabilization can improve clinical outcomes for patients.

This included a 50% reduction in the cumulative frequency of CVH relative to placebo at Month 30.

BridgeBio’s marketing application is under FDA review, with a PDUFA action date of November 29, 2024. It also has a marketing application to the European Medicines Agency, with a decision expected in 2025.

BridgeBio has granted Bayer AG BAYRY exclusive rights to commercialize ceramides for ATTR-CM in Europe.

William Blair writes that reducing overall mortality is crucial for competing in the ATTR-CM market against Pfizer Inc’s PFE tafamidis, which already includes proven mortality benefits on its label from the ATTR-ACT trial.

The analyst writes, “While Bridge Bio continues to publish analyses of acoramidis demonstrating the TTR stabilizer is safe and efficacious, we deem an on-label claim to all-cause mortality benefit as an important factor for market share in the lucrative, but competitive, ATTR-CM space.”

Price Action: BBIO stock is up 0.85% at $22.54 at the last check on Tuesday.

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