BridgeBio is delving deeper into the phase 3 research of acoramidis, focusing on individuals suffering from transthyretin amyloid cardiomyopathy (also known as ATTR-CM). The research sheds light on the treatment’s potential to prevent fatalities caused by cardiovascular-related conditions.
The recent findings, presented at the annual meeting of the European Society of Cardiology on Sunday, highlight that acoramidis is associated with a relative 30% decrease in the risk of deaths caused by cardiovascular disease when compared to a placebo. Those who received the therapy experienced a mortality rate of 21.3%, in contrast to the 15% rate in the placebo group.
According to BridgeBio’s findings, 79% of the fatalities observed during the research were “cardiovascular (CV) in nature.” The data, shared in a presentation to shareholders, shows that the overall relative risk decrease in mortality was 25% among individuals treated with acoramidis compared to those given the placebo.
Considering that all-cause mortality was the only element in the primary hierarchy of endpoints for the organization that did not display statistically significant growth, the segmentation of the mortality data is notably significant. The company did not specify in its press statement whether the proportional decrease in death rates due to cardiovascular conditions was statistically significant.
Additionally, the Bay Area biotech expanded on previously released hospitalization data, revealing that the average annual hospitalization rate among individuals on acoramidis was 0.29, a figure comparable to the annual hospitalization rate for Medicare patients in the U.S. The Pfizer-manufactured Vyndaqel brand had an average annual hospitalization rate of 1.00.
Further information was disclosed regarding the performance of patients who underwent a six-minute walk test while being treated with acoramidis. At month 30, 40% of acoramidis patients reported improvement, compared to 22% of those given a placebo. However, the firm did not provide the average test results for either group.
Upon the initial release of the results in July, BridgeBio’s initial confidence was reaffirmed by the data. The organization remains on track to submit an application for FDA approval by the end of the current year, with subsequent submissions planned for additional markets in 2024. Additionally, BridgeBio intends to initiate primary preventive research in the coming year.
The FDA is anticipated to make a decision in early October about whether to expand the drug’s label to include ATTR-CM. The company aims to enter the market approximately one year after Alnylam’s Onpattro, which has already received approval to treat ATTR polyneuropathy.