BridgeBio's heart disease drug meets late-stage study goal, shares soar

[July 18, 2023]  By Khushi Mandowara

(Reuters) -BridgeBio Pharma Inc's experimental drug for a rare heart disease showed significant improvement in patients in a late-stage study, sending its shares surging 65% on Monday.

The drug, acoramidis, is being developed to treat transthyretin amyloid cardiomyopathy in which abnormal deposits of a protein called amyloid buildup in the heart, and can cause heart failure.

The drug is expected to compete with Alnylam Pharmaceuticals' patisiran, which is under regulatory review for cardiomyopathy, and Pfizer's Vyndamax, or tafamidis, already approved in the U.S for the condition.

Patisiran and tafamidis have received the nod for treating another symptom of the disease called polyneuropathy.

In the trial, acoramidis was 1.8 times better than placebo when measured for preventing death, hospitalization and improvement in 6 minutes walking distance.

BridgeBio's drug improved survival by 81% in the study patients compared to 74% on the placebo, and also reduced frequency of heart disease-related hospitalization by 50%.

The California-based company also provided additional data comparing it with Pfizer's drug. Acoramidis showed 92% improvement on heart failure test, compared to patients on placebo and Pfizer's drug at 30 months.

The additional data suggests that BridgeBio's drug was better than tafamidis in controlling the disease, said TD Cowen analyst Tyler Van Buren.

However, the company said effectiveness of the two drugs cannot be directly compared as that was not the goal of the trial.

Data from BridgeBio's drug also "bodes well" for other companies developing similar treatments such as Alnylam and Ionis Pharmaceutical, RBC Capital Markets analyst Luca Issi said.

BridgeBio plans to submit the data to the U.S. Food and Drug Administration (FDA) by the end of 2023 as part of its marketing application. The company also expects to file in additional markets next year.

BridgeBio's shares were trading at $30, while Alnylam's stock rose 10.5% to $217.9.

(Reporting by Khushi Mandowara in Bengaluru; Editing by Nivedita Bhattacharjee and Sriraj Kalluvila)
 

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