Rob Dillard

DocwireNews

Bridge Bio Pharma presented results from a post-hoc analysis which demonstrated the efficacy of acoramidis on the composite end point of reducing all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVHs) in patients with <span class="c5aZPb" tabindex="0" role="button" data-enable-toggle-animation="true" data-extra-container-classes="ZLo7Eb" data-hover-hide-delay="1000" data-hover-open-delay="500" data-send-open-event="true" data-theme="0" data-width="250" data-ved="2ahUKEwielq6cq-uIAxVsFlkFHSwvLmcQmpgGegQILBAD">transthyretin amyloid cardiomyopathy (ATTR-CM). The findings were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2024.
“We are proud to share the results of this post-hoc analysis demonstrating a highly significant reduction in all-cause mortality and the sum of recurrent CV-related hospitalizations in patients with ATTR-CM at 30 Months in the ATTRibute-CM trial,” said Jonathan Fox, MD, PhD, chief medical officer of BridgeBio Cardiorenal via a <a href="https://investor.bridgebio.com/news-releases/news-release-details/bridgebio-shares-recurrent-event-analysis-attribute-cm" target="_blank" rel="noopener">press release.</a> “At BridgeBio, we believe in the importance of both data transparency and continued communication of additional details of this landmark trial, especially to assist physicians choosing ATTR-CM therapies for their patients who rely on their healthcare provider’s recommendations. By conducting and presenting multiple analyses, we hope to both advance the clinical science around ATTR-CM trials and highlight the potential for acoramidis to be a meaningful treatment option for patients.”
This analysis, presented by Daniel Judge, MD, professor of medicine and cardiology at the Medical University of South Carolina in an oral presentation, demonstrated:
<ul type="disc">
<li>A 42% reduction in composite ACM and recurrent CVH events at 30 months in patients treated with acoramidis compared to placebo using a binomial regression model (post-hoc) (p=0.0005)</li>
<li>A 42% reduction in the total number of ACM and recurrent CVH events per patient observed over 30 months with acoramidis treatment compared to placebo.</li>
<li>An over 30% hazard reduction in ACM and recurrent CVH events at 30 months observed with acoramidis treatment compared to placebo by applying the Andersen-Gill model (post-hoc) (p=0.0008)</li>
</ul>
“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,” remarked Dr. Judge.
Bridge Bio noted that based on the findings of the ATTRibute-CM trial, they have submitted a New Drug Application to the U.S. Food and Drug Administration, 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.

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Bridge Bio Pharma presented results from a post-hoc analysis which demonstrated the efficacy of acoramidis in ATTR-CM.

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