BridgeBio Reports Positive Outcomes in ATTRibute-CM Study
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BridgeBio Shares Promising Data from ATTRibute-CM Study
In a recent study, participants transitioning from tafamidis and placebo to acoramidis in the ATTRibute-CM open-label extension showed significant improvements in serum transthyretin (TTR) levels. At the first month of treatment, there was a notable mean increase of 3.0 mg/dL in serum TTR (n=21) followed by a 3.4 mg/dL increase by Month 6 (n=18).
Correlation Between Serum TTR and Patient Outcomes
A critical finding of the study revealed that heightened serum TTR levels at Day 28 were linked with a decreased risk of all-cause mortality (ACM), cardiovascular mortality (CVM), and cardiovascular-related hospitalization (CVH) in patients suffering from transthyretin amyloid cardiomyopathy (ATTR-CM). This correlation underscores the significance of serum TTR stabilization as a marker of clinical improvement.
Impact of Acoramidis on Clinical Outcomes
The study demonstrated that acoramidis, a highly effective stabilizer of TTR, considerably enhances clinical outcomes for patients. Specific benefits observed in the study included:
- An early and lasting improvement in the time to the first event (either CVH or ACM) starting as early as Month 3.
- A significant 42% reduction in the composite events of CVH and ACM at Month 30 compared to placebo.
- A remarkable 50% decrease in the cumulative frequency of CVH events at Month 30.
Scientific Insights from the ATTRibute-CM Study
At a recent presentation, Mathew Maurer, M.D., from Columbia University Irving Medical Center, highlighted the analysis comparing those receiving acoramidis to participants in the tafamidis and placebo groups. The initial findings, shared previously, demonstrated that by Day 28, higher TTR levels not only correlated with better patient survival but also significantly impacted the quality of life of participants.
Further Developments and Future Implications
The ongoing partnership between BridgeBio and the Cardiovascular Data Science (CarDS) Lab aims to utilize advanced artificial intelligence tools in the TRACE AI Network Study. This study will enable comprehensive screening strategies across multiple health systems, targeting the undiagnosed cases of ATTR-CM, especially in distinct socioeconomic and demographic groups.
In light of the promising results from the ATTRibute-CM study, BridgeBio has taken proactive steps by submitting a New Drug Application to the U.S. Food and Drug Administration (FDA), which is under review. This submission aligns with a Marketing Authorization Application to the European Medicines Agency, with decisions anticipated over the next year.
About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative therapies for genetic diseases. Established in 2015, BridgeBio's experienced team is committed to accelerating advancements in genetic medicine. The company actively engages in both early and advanced clinical development programs.
Frequently Asked Questions
What is the ATTRibute-CM study?
The ATTRibute-CM study is a Phase 3 clinical trial evaluating the efficacy and safety of acoramidis for treating patients with transthyretin amyloid cardiomyopathy (ATTR-CM).
What were the main findings regarding serum TTR levels?
The study found that patients who switched to acoramidis had increases in serum TTR levels, which were associated with improved survival rates and reduced hospitalization risks.
How does acoramidis compare to tafamidis?
Acoramidis has demonstrated better stabilization of TTR levels compared to tafamidis, significantly improving clinical outcomes in patients with ATTR-CM.
What does the future hold for the treatment of ATTR-CM?
BridgeBio is actively pursuing regulatory approvals for acoramidis, indicating a hopeful future for more effective treatments for ATTR-CM patients.
Who can be contacted for more information about BridgeBio?
For inquiries, Vikram Bali at BridgeBio can be reached via email at contact@bridgebio.com or by phone at (650)-789-8220.
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