Latest BridgeBio data support acoramidis benefit in ATTR-CM
Clinical ResultPhase 3Drug ApprovalAHA
BridgeBio Pharma announced on Thursday that acoramidis increased serum transthyretin (TTR), which is associated with improved cardiovascular outcomes, in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). The latest data from a Phase III ATTRibute-CM study were presented at the International Symposium of Amyloidosis (ISA).
A filing for the small-molecule, orally-administered TTR stabiliser is under review in the US, with the FDA set to make a decision by November 29. Earlier this year, Bayer gained exclusive rights to commercialise acoramidis in Europe pending approval in the region. Both the marketing applications are based on findings from the study in which acoramidis demonstrated an 81% absolute survival rate in patients who received the treatment, and a mean annual frequency of 0.29 for cardiovascular-related hospitalisations.
The latest data confirmed the correlation between increased serum TTR and improved clinical outcomes, including the reduced risk of all-cause mortality (ACM) and cardiovascular mortatlity (CVM) as well as cardiovascular-related hospitalisation (CRH). Acoramidis treatment resulted in increased serum TTR levels by day 28 that were sustained and correlated with a reduced risk of all- ACM by as much as 51%, CVM by 5.5% and CVH by 4.7% through month 30. Acoramidis treatment resulted in a significant improvement in the composite endpoint of CVM and CVH, with a 15.2% absolute risk reduction and a 38.2% hazard reduction by month 30.
"We remain encouraged by the potential benefits of targeting near-complete TTR stabilisation, the resulting increases in serum TTR, and the corresponding statistically significant benefits on clinical event outcomes," said chief medical officer Jonathan Fox. "We are committed to bringing acoramidis to the ATTR-CM community as quickly as possible, working toward our November 29 PDUFA date."
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