BridgeBio (BBIO) Pharma presented initial outcomes from the ATTRibute-CM open-label extension 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, near-complete, orally-administered, small molecule stabilizer of TTR. The preliminary results from this ongoing OLE study were also simultaneously published in Circulation. The OLE study involves 330 participants who completed the 30-month ATTRibute-CM Phase 3 study. Key initial results from the OLE study, presented by Dr. Judge at AHA, show that continuous treatment with acoramidis led to: A confirmed sustained improvement relative to placebo in time to first event starting at Month 3 in ATTRibute-CM; A statistically significant reduction in ACM alone of 36% by Month 36 and 34% by Month 42, as assessed by the Stratified Cox proportional hazards model; A significant reduction of composite ACM and CVH by 46% at Month 36 and 48% at Month 42 as assessed by negative binomial regression, building upon the previously presented 42% reduction at Month 30 in ATTRibute-CM; Evidence of early benefit in patients who crossed over from placebo to acoramidis after Month 30 as compared to extrapolated placebo curve reinforces the early separation seen previously 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 stabilization can improve clinical outcomes for patients. This included a 50% reduction in the cumulative frequency of CVH relative to placebo at Month 30.
Don't Miss our Black Friday Offers:
- Discover the latest stocks recommended by top Wall Street analysts, all in one place with Analyst Top Stocks
- Make smarter investments with weekly expert stock picks from the Smart Investor Newsletter
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See Insiders’ Hot Stocks on TipRanks >>
Read More on BBIO:
- BridgeBio announces publication of PROPEL 2 data in NEJM
- BridgeBio price target raised to $45 from $44 at Scotiabank
- BridgeBio Pharma Reports Quarterly Loss Amid Restructuring
- BridgeBio reports Q3 EPS (86c), consensus (98c)
- BridgeBio announces publication on impact of biomedical innovation
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
