BridgeBio released additional analyses of its Phase 3 study of acoramidis in ATTR-CM on Wednesday, spotlighting the link between serum transthyretin (TTR) levels and the drug’s long-term efficacy in endpoints like survival and hospitalization.
According to the analyses presented at the International Symposium on Amyloidosis, there is a “statistically significant correlation” between increasing serum TTR levels and a decreased risk of death, cardiovascular death, and cardiovascular-related hospitalization through 30 months of treatment.
For each increase in 1 mg of serum TTR levels on day 28 of treatment, the risk of cardio death was reduced by 5.5% through month 30, which the company added is the first prospective demonstration of the correlation between serum TTR levels and the decrease in risk of cardiovascular death in the disease.
“Prior analyses from [the Phase 3] ATTRibute-CM demonstrated that the near-complete stabilization by acoramidis rapidly and durably increased serum TTR levels,” Mathew Maurer, a doctor at the Columbia University Irving Medical Center, wrote in a statement. “Clinically, we now have evidence that acoramidis-mediated increase in serum TTR independently predicted statistically significant improvement in survival, and risk reduction of [cardiovascular mortality] and [cardiovascular-related hospitalization].”
BridgeBio also presented data this week that showed acoramidis beat out Pfizer’s competitor Vyndamax (tafamidis), which is already approved in the disease. Mizuho analysts said that acoramidis achieved 100% survival at month 36, beating out tafamidis, writing that “the data here support the commercial narrative that acoramidis should get used over tafamidis.”
Acoramidis is currently under review by the FDA. Vyndamax was first approved in ATTR-CM in 2019.