attruby logo
linkHome

Connect with us

All fields are required.

BridgeBio is committed to protecting and respecting your privacy. All information collected will be handled in accordance with our Privacy Policy. By clicking "Submit," you agree to share your contact information and certain health information with BridgeBio, BridgeBio affiliates, and companies working with BridgeBio or BridgeBio affiliates (collectively, "BridgeBio"). You agree that BridgeBio may contact you by mobile or online digital media, mail, email, fax, telephone call, and text messages (including autodialed and prerecorded calls and messages) for marketing purposes, including targeted online marketing, or to otherwise provide you with information about BridgeBio's products, treatment, or other offers. You can unsubscribe from these communications at any time by clicking "Unsubscribe" in the communications you receive.

Connect with us

All fields are required.

BridgeBio is committed to protecting and respecting your privacy. All information collected will be handled in accordance with our Privacy Policy. By clicking "Submit," you agree to share your contact information and certain health information with BridgeBio, BridgeBio affiliates, and companies working with BridgeBio or BridgeBio affiliates (collectively, "BridgeBio"). You agree that BridgeBio may contact you by mobile or online digital media, mail, email, fax, telephone call, and text messages (including autodialed and prerecorded calls and messages) for marketing purposes, including targeted online marketing, or to otherwise provide you with information about BridgeBio's products, treatment, or other offers. You can unsubscribe from these communications at any time by clicking "Unsubscribe" in the communications you receive.

Thank you for signing up.

Check your inbox for a message from us!

Actor portrayals.
Actor portrayal.

Clinical Data

Attruby is proven to make
an impact on survival,
hospitalizations, and
quality of life1,2

Secondary Endpoints
Primary Endpoint
(ACM/CVH)
Survival
(ACM)
Hospitalizations
(CVH)
KCCQ-OS/
6MWD
Laboratory Findings
(Serum TTR/NT-proBNP)

Attruby is proven to significantly reduce the combination of all-cause
mortality and CV-related hospitalizations at 30 months1,2

The primary composite endpoint included all-cause mortality (ACM) and cumulative
frequency of cardiovascular-related hospitalizations (CVH) over 30 months

All cause

All-cause mortality

CV-related hospitalization

Frequency of CV-related
hospitalizations

P=0.018, assessed using the stratified F-S test info

Deliver meaningful reductions in ACM and CVH for today's patient population

Learn more about the ATTRibute-CM clinical trial info and the
primary hierarchical composite endpoint info .

See Study Design Arrow right More on the Hierarchical Composite Endpoint Arrow right

Attruby showed a rapid observable
difference that lasted over time1

In as early as 3 months, the time to first event (ACM or CVH) curves
began separating and diverged through 30 months

Time to First Event (ACM or CVH)1
Table Table
Table
Number
needed to
treat to avoid
death or first CVH
over 2.5 years1:
7
36% RRR in time
to first event
(ACM or first CVH)1

In a post hoc analysis,

42% RRR

in the composite of ACM and recurrent CVH3*

image Actor portrayals.

*RRR was calculated using the negative binomial regression model. The total number of events for Attruby compared with placebo (2:1 randomized) was
79 vs 52 for ACM, respectively, and 182 vs 170 for CVH, respectively.3

6MWD=6-minute walk distance; ACM=all-cause mortality; CV=cardiovascular; CVH=cardiovascular-related hospitalization; F-S test=Finkelstein-Schoenfeld test;
HR=hazard ratio; NT-proBNP=N-terminal pro–B-type natriuretic peptide; RRR=relative risk reduction.

References: 1. Attruby. Prescribing information. BridgeBio, Inc.; 2024. 2. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. N Engl J Med. 2024;390(2):132-142. doi:10.1056/NEJMoa2305434 3. Judge DP, Alexander KM, Cappelli F, et al. Acoramidis improves clinical outcomes in patients with transthyretin amyloid cardiomyopathy: post hoc recurrent event analyses of ATTRibute-CM. Poster presented at: Heart Failure Society of America Annual Scientific Meeting; September 27-30, 2024; Atlanta, GA. 4. Data on file. BridgeBio, Inc.; 2024. 5. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy [study protocol]. N Engl J Med. 2024;390(2):132-142. doi:10.1056/NEJMoa2305434

Select an endpoint for more Attruby data

Secondary Endpoints
Primary Endpoint
(ACM/CVH)
Survival
(ACM)
Hospitalizations
(CVH)
KCCQ-OS/
6MWD
Laboratory Findings
(Serum TTR/NT-proBNP)
Select Endpoint
Primary Endpoint (ACM/CVH) icon

Attruby is proven to significantly reduce the combination of all-cause mortality and CV-related hospitalizations at
30 months1,2

The primary composite endpoint included all-cause mortality
(ACM) and cumulative frequency
of cardiovascular-related
hospitalizations (CVH) over
30 months

All cause

All-cause
mortality

CV-related hospitalization

CV-related
hospitalization

P=0.018, assessed using the
stratified F-S test info

Deliver meaningful reductions in ACM and CVH for today's patient population

Learn more about the
ATTRibute-CM clinical trial info
and the primary hierarchical
composite endpoint info .

See Study Design Arrow right More on the Hierarchical Composite Endpoint Arrow right

Attruby showed a rapid observable difference that lasted over time1

In as early as 3 months, the time to first event (ACM or CVH) curves began separating and diverged through 30 months

Time to First Event (ACM or CVH)1
Table Table
Table
Number
needed to
treat to avoid
death or first CVH
over 2.5 years1:
7
36% RRR in time
to first event
(ACM or first CVH)1

In a post hoc analysis,

42% RRR

in the composite of ACM and recurrent CVH3*

image Actor portrayals.

*RRR was calculated using the negative binomial regression model. The total number of events for
Attruby compared with placebo (2:1 randomized)
was 79 vs 52 for ACM, respectively, and 182 vs 170
for CVH, respectively.3

6MWD=6-minute walk distance; ACM=all-cause mortality; CV=cardiovascular; CVH=cardiovascular-related hospitalization; F-S test=Finkelstein-Schoenfeld test; HR=hazard ratio; NT-proBNP=N-terminal pro–B-type natriuretic peptide; RRR=relative risk reduction.

References: 1. Attruby. Prescribing information. BridgeBio, Inc.; 2024. 2. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. N Engl J Med. 2024;390(2):
132-142. doi:10.1056/NEJMoa23054343. Judge DP, Alexander KM, Cappelli F, et al. Acoramidis improves clinical outcomes in patients with transthyretin amyloid cardiomyopathy: post hoc recurrent event analyses of ATTRibute-CM. Poster presented at: Heart Failure Society of America Annual Scientific Meeting; September 27-30, 2024; Atlanta, GA.4. Data on file. BridgeBio, Inc.; 2024. 5. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy [study protocol]. N Engl J
Med. 2024;390(2):132-142. doi:10.1056/NEJMoa2305434

Select an endpoint for more Attruby data

Attruby made an
impact on ACM, a key
secondary endpoint1-3

The treatment effect of Attruby on ACM was studied in a contemporary ATTR-CM
population that reflects recent approaches in diagnosis
and care4,5*
Key Secondary Endpoint:
All-Cause Mortality (ACM)4
Table
Table
81% of patients remained alive at
30 months
vs 74% with placebo; Cox HR=0.77
(95% CI: 0.54-1.10); CMH P=0.0573-5

In a post hoc analysis applied
to the ITT† population, which included
patients with stage 4 CKD, Attruby reduced the risk of ACM
Cox HR=0.762 (95% CI: 0.524-1.072); CMH P=0.0396

*The proportion of trial participants in the earlier stages of disease (ie, NYHA Class I and II) reflects changes in
disease recognition and management in recent years,
which have resulted in improved overall survival.4,5

†Based on ITT population of 632 patients, including 21
who had stage 4 CKD. The ITT population was defined
as all randomized participants who received at least
1 dose of study drug and had at least 1 postbaseline
efficacy evaluation and included participants who had
a baseline eGFR <30 mL/min/1.73 m2.4

ACM=all-cause mortality; CKD=chronic kidney disease; CMH=Cochran-Mantel-Haenzel test; CVM=cardiovascular-related mortality; eGFR=estimated glomerular filtration rate; HR=hazard ratio;
ITT=intent-to-treat. NYHA=New York Heart Association.

References: 1. Attruby. Prescribing information. BridgeBio, Inc.; 2024. 2. Data on file. BridgeBio, Inc.; 2024. 3. Judge DP. Acoramidis improves clinical outcomes in ATTR-CM: additional data from ATTRibute-
CM phase 3 study. Presented at: ATTRibute-CM AHA Investor Webcast. November 12, 2023. 4. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. N Engl J Med. 2024;390(2):132-142. doi:10.1056/
NEJMoa2305434
5. Ioannou A, Patel RK, Razvi Y, et al. Impact of earlier diagnosis in cardiac ATTR amyloidosis over the course of 20 years. Circulation. 2022;146(22): 1657-1670. doi:10.1161/CIRCULATIONAHA.122.060852 6. Poulsen S, Gillmore JD, Alexander KM, et al. ATTRibute-CM: ITT sensitivity analysis and sub-analysis comparing acoramidis and placebo in stage 4 CKD. Paper presented at: 2024 International Symposium on Amyloidosis; May 26-30, 2024; Rochester, MN.

Attruby delivered a
substantial decrease in
the frequency of CV-related
hospitalizations vs placebo1,2

Other secondary endpoint: CVH frequency 50%RRR The mean number of CVH events was 0.3 per year for Attruby-treated patients compared with 0.6 per year for placebo1
golf game Actor portrayals.

CVH=cardiovascular-related hospitalization;
RRR=relative risk reduction. References: 1. Attruby. Prescribing information. BridgeBio, Inc.; 2024. 2. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. N Engl J Med. 2024;390(2):132-142. doi:10.1056/NEJMoa2305434 3. Data on file. BridgeBio, Inc.; 2024.

Attruby positively impacted
patients' health-related
quality of life compared
with placebo1

Attruby achieved statistically significant results in health-related
quality of life (KCCQ-OS info )
at Month 30 (P<0.0001)

Key Secondary Endpoint:
Change From Baseline in KCCQ-OS1

Table Table
Table
Positive impact first
observed as early
as 3 months1
LS mean difference of 10 points at Month 30 (95% CI: 5.97-13.91;
P<0.0001)1,2

Some studies have shown that a mean 5-point change reflects a clinically meaningful change in health status3

At 30 months, patients
treated with Attruby had
better 6MWD results than
those who were not treated
with Attruby1

Key Secondary Endpoint:
Change From Baseline in 6MWD1

Table
Table
Functional Capacity (6MWD) 40 meters Difference compared with placebo
in 6MWD change from baseline (P<0.0001)1
golf game Actor portrayals.

6MWD=6-minute walk distance; KCCQ-OS=Kansas City Cardiomyopathy Questionnaire Overall Summary;
LS mean=least-squares mean.

References: 1. Attruby. Prescribing information. BridgeBio, Inc.; 2024. 2. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. N Engl J Med. 2024;390(2):132-142. doi:10.1056/NEJMoa2305434 3. Spertus JA, Jones PG, Sandhu AT, Arnold SV. Interpreting the Kansas City Cardiomyopathy Questionnaire in clinical trials and
clinical care: JACC state-of-the-art review. J Am Coll Cardiol. 2020;76(20):2379-2390. doi:10.1016/
j.jacc 2020.09.542

Attruby demonstrated rapid and sustained
increase in serum TTR1,2

Attruby delivered near-complete (>90%) in vitro TTR stabilization
in as early as 28 days1,2

Key Secondary Endpoint:
Change From Baseline in Serum TTR Level2*

Table
Table
connected circles icon

Levels of serum TTR, also known as prealbumin, are a measure of stabilized TTR3

Testing can give you and your patients the confidence of knowing if Attruby is working

Lower TTR levels have been
associated with worsening outcomes3,4†

*Per standard protocol, any missing values were imputed as placebo values.5

†Based on a retrospective analysis of multivariate predictors of shorter overall survival in 116 patients with biopsy-proven ATTRwt.3

Attruby made an impact on NT-proBNP2

NT-proBNP elevation at Month 30 favored Attruby and was 52.9% of placebo‡

Other Secondary Endpoint: Change From Baseline in NT-proBNP Over Time2‡

Table
Table

Elevated levels of NT-proBNP are an indicator of heart stress6

‡Prespecified, non-alpha protected secondary endpoint.5

ATTRwt=wild-type transthyretin amyloidosis;
LS mean=least-squares mean; NT-proBNP=N-terminal pro–B-type natriuretic peptide; TTR=transthyretin.

References: 1. Attruby. Prescribing information.
BridgeBio, Inc.; 2024. 2. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. N Engl J Med. 2024;390(2):
132-142. doi:10.1056/NEJMoa2305434 3. Judge DP, Heitner SB, Falk RH, et al. Transthyretin stabilization by AG10 in symptomatic transthyretin amyloid cardiomyopathy. J Am Coll Cardiol. 2019;74(3):285-295. doi:10.1016/j.jacc.2019.03.012 4. Hanson JLS, Arvanitis M, Koch CM, et al. Use of serum transthyretin
as a prognostic indicator and predictor of outcome in cardiac amyloid disease associated with wild-type transthyretin. Circ Heart Fail. 2018;11(2):e004000.
doi:10.1161/CIRCHEARTFAILURE.117.004000 5. Greve AM, Christoffersen M, Frikke-Schmidt R, Nordestgaard BG, Tybjaerg-Hansen A. Association of low plasma transthyretin concentration with risk of heart failure in
the general population. JAMA Cardiol. 2021;6(3):258-266. doi:10.1001/jamacardio.2020.5969 6. Data on file.
BridgeBio, Inc.; 2024. 7. Suzuki S, Sugiyama S. The molar ratio of N-terminal pro-B-type natriuretic peptide/B-type natriuretic peptide for heart failure-related events in stable outpatients with cardiovascular risk factors.
Internal Medicine. 2018;57(18):2621-2630. doi:10.2169/
internalmedicine.0471-17

Select an endpoint for more
Attruby data
Primary Endpoint (ACM/CVH) icon

Attruby was studied in a contemporary
ATTR-CM population that reflects recent
approaches in diagnosis and care

Attruby was studied
in a contemporary
population that reflects
recent approaches in
diagnosis and care

See Study Design Arrow right
The F-S test is a statistical method based on the principle that each subject is compared to every other subject in each stratum in a pair-wise, hierarchical manner. ACM and cumulative CVH were considered to be the most clinically important components within the hierarchical endpoint and were appropriately the first and second components of
the hierarchy.

The F-S test results in a P value relating to the statistical significance of the difference noted between treatment and placebo groups but does not provide a magnitude of benefit. The magnitude of benefit is shown by the win ratio.5 The 4-step primary hierarchical
composite endpoint evaluated
in the ATTRibute-CM clinical
trial included ACM, CVH, change
from baseline in NT-proBNP, and
change from baseline in 6MWD
(assessed using the stratified F-S
test).

The Attruby USPI describes the
primary endpoint as a 2-part
composite that includes ACM and
cumulative frequency of CVH over
30 months.1,2 ATTRibute-CM was a phase 3, randomized (2:1), double-blind, placebo-controlled study that assessed the efficacy (N=611) and safety (N=632) of Attruby in adults with hereditary or wild-type cardiac amyloidosis over 30 months. The primary endpoint was a 4-part hierarchical composite (ACM, CVH, CFB in NT-proBNP, CFB in 6MWD).1,2 The win ratio was calculated to aid the interpretation of results from the F-S scoring algorithm to show the magnitude of effect between
Attruby and placebo. The stratified nonmatched win ratio method allocated all treated and placebo pairs within each stratum in the same hierarchical structure as the
F-S test.

In ATTRibute-CM, Attruby achieved a statistically significant
1.8 win ratio in the 4-component composite.2,5 Reductions in cardiovascular hospitalizations indicate better management of heart failure symptoms, leading to fewer acute episodes that require hospital care.3 The Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) is a patient-reported questionnaire designed to evaluate the impact of heart failure on a patient's physical and social functioning, as well as their symptoms and quality of life.3

INDICATION

Attruby™ (acoramidis) is indicated for the treatment of cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION

Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation.

Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

Laboratory Tests
Mean increase in serum creatinine of 0.2 and 0.0 mg/dL and a mean decrease in eGFR of 8.2 and 0.7 mL/min/1.73 m2 was observed in the adults with ATTR-CM treated with Attruby versus placebo, respectively, at Day 28 and then stabilized. These changes were reversible after treatment discontinuation.

Use in Specific Populations

Pregnancy & Lactation: There are no data on the use of Attruby in pregnant women. Animal data have not shown developmental risk associated with the use of Attruby in pregnancy. There are no available data on the presence of Attruby in either human or animal milk or the effects of the drug on the breastfed infant or maternal milk production.

Please see Full Prescribing Information including Patient Information.

INDICATION AND IMPORTANT
SAFETY INFORMATION

INDICATION

Attruby™ (acoramidis) is indicated for the treatment of cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION

Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation.

Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

Laboratory Tests
Mean increase in serum creatinine of 0.2 and 0.0 mg/dL and a mean decrease in eGFR of 8.2 and 0.7 mL/min/1.73 m2 was observed in the adults with ATTR-CM treated with Attruby versus placebo, respectively, at Day 28 and then stabilized. These changes were reversible after treatment discontinuation.

Use in Specific Populations

Pregnancy & Lactation: There are no data on the use of Attruby in pregnant women. Animal data have not shown developmental risk associated with the use of Attruby in pregnancy. There are no available data on the presence of Attruby in either human or animal milk or the effects of the drug on the breastfed infant or maternal milk production.

Please see Full Prescribing Information including Patient Information.