BridgeBio Shares Recurrent Event Analysis of ATTRibute-CM, Demonstrating a 42% Reduction by Acoramidis on the Composite Endpoint of All-Cause Mortality and Recurrent Cardiovascular-related Hospitalization Events
– Acoramidis treatment led to a highly significant reduction in all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVH) at Month 30 compared with placebo
– Additionally, results from a Phase 3 trial in adults with ATTR-CM conducted in Japan were presented, with no ACM events reported over the 30 month treatment period in participants administered acoramidis
– Greater transthyretin (TTR) stabilization has been associated with improved clinical outcomes for patients, and in ATTRibute-CM, acoramidis, a near-complete stabilizer of TTR, demonstrated a significant impact on mortality, hospitalizations, and quality of life including:
– An early and sustained improvement relative to
placebo in time to first event (CVH or ACM) with a separation
of event rates starting at Month 3
– A 42% reduction in composite ACM and recurrent CVH
events relative to placebo at Month 30
– A 50% reduction in the cumulative frequency of CVH
events relative to placebo at Month 30
PALO ALTO, Calif., Sept. 27, 2024 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, presented a post-hoc analysis evaluating the effect of acoramidis on the composite endpoint of ACM and recurrent CVH events in its Phase 3 ATTRibute-CM study in ATTR-CM at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2024. ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis, an investigational, near-complete, orally-administered, small molecule stabilizer of TTR.
“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, M.D., Ph.D., chief medical officer of BridgeBio Cardiorenal. “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.”
The analysis, shared by Daniel Judge, M.D., professor of medicine and cardiology at the Medical University of South Carolina in an oral presentation, included:
- A 42% reduction in composite ACM and recurrent CVH events at 30 months observed with acoramidis treatment compared to placebo by applying a negative binomial regression model (post-hoc) (p=0.0005)
- 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
- A 30.5% 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)
“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 Dr. Judge.
Additionally, during the Annual Scientific Session of the Japanese College of Cardiology (JCC), Jin Endo, M.D., Ph.D., Keio University School of Medicine of Tokyo, Japan presented positive results from the Phase 3 trial of acoramidis in adults with ATTR-CM conducted by Alexion, AstraZeneca Rare Disease in Japan, which has exclusive rights to commercialize acoramidis in Japan. No mortality was reported over the treatment period of 30 months. Results showed consistency with the ATTRibute-CM results, including survival, CVH and other measures of physical function (measured by six-minute walk test) and quality of life (measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score) at 30 months.
Based on the positive results from ATTRibute-CM, BridgeBio 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.
About BridgeBio Pharma, Inc.
BridgeBio Pharma Inc. (BridgeBio) is a commercial-stage
biopharmaceutical company founded to discover, create, test and
deliver transformative medicines to treat patients who suffer
from genetic diseases. BridgeBio’s pipeline of development
programs ranges from early science to advanced clinical trials.
BridgeBio was founded in 2015 and its team of experienced drug
discoverers, developers, and innovators are committed to
applying advances in genetic medicine to help patients as
quickly as possible. For more information visit bridgebiodev.wpengine.com and follow us on LinkedIn, Twitter and Facebook.
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