BridgeBio Pharma, Inc. (BBIO) stock plunged 70.49% in the current-market trading session at the price of $11.98 after reporting topline results from the ongoing ATTRibute-CM Study. BBIO is a biopharmaceutical firm that discovers, designs, and delivers transformative therapies to treat patients with genetic diseases and cancers.
BBIO Published Topline Results from ATTRibute-CM Study
On 27th December 2021, BBIO reported month 12 topline results from its ongoing ATTRibute-CM study. It is a Phase-3 study that investigates acoramidis to treat transthyretin amyloid cardiomyopathy (ATTR-CM). The Part A of the study (Month 12) compares change from baseline in 6MWD. Part B of the study (Month 30) uses a hierarchical comparison including cardiovascular hospitalizations and all-cause mortality.
The mean observed decline in 6MWD for patients receiving acoramidis or placebo with baseline eGFR ≥ 30 mL were 9m and 7m, respectively. The drop in both arms of ATTRibute-CM was parallel to the anticipated functional decline in healthy adults. The decline in the ATTRibute-CM placebo group was over 70% lower than the one detected in the ATTR-ACT treatment group. ATTRibute-CM registered 632 participants with ATTR-CM, related to either variant TTR or wild-type, with New York Heart Association Class I-III symptoms.
Chief executive officer of BBIO, Neil Kumar, remarked that the topline results are quite disappointing and bewildering. He with many others finding out answers concerning the 6MWD. These results do not seem to be caused by a baseline imbalance. They are now evaluating the hypotheses that include training bias, context bias, development in diagnosis, and standard of care.
Neil Kumar added that the drug is well-tolerated and is pharmacologically active. They had observed improvement in quality of life with favorable trends on negative events causing death. He is optimistic that the drug will offer benefits if they keep observing clinical outcomes till Month 30.
Co-chair of the ATTRibute-CM Steering Committee, Daniel Judge, remarked that though the results were not in accordance with their expectations. But the Part B readout will be very important where they will observe the results of acoramidis on cardiovascular hospitalizations and all-cause mortality.