Clinical Trials

Inclusion Criteria:

1. Completed 30 months of the blinded study treatment in Study AG10-301 and the Study
AG10-301 Month 30 visit including assessments and procedures.

2. Have the ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures.

3. Female participants of childbearing potential who engage in heterosexual intercourse
must agree to use a highly effective method of contraception beginning with enrollment
and continuing for 30 days after the last dose of acoramidis. Female participants
using oral contraceptives must agree to use an additional birth control method. While
not considered highly effective, a double-barrier method is acceptable. A male
participant who is sexually active with a female of childbearing potential and has not
had a vasectomy must agree to use a double-barrier method of birth control.

Exclusion Criteria:

1. Acute myocardial infarction, acute coronary syndrome or coronary revascularization
within 90 days prior to Day 1 stroke or transient ischemic attack (TIA) within 90 days
prior to Day 1.

2. Has hemodynamic instability, that in the judgment of the Investigator, would pose too
great a risk for participation in the study.

3. Has had a heart and/or liver transplant or is on the heart transplantation list within
the year prior to Day 1

4. Has had implantation of a cardiac mechanical assist device (CMAD) or is scheduled for
implantation of a CMAD

5. Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study
AG10-301.

6. Has estimated glomerular filtration rate (eGFR) by modification of diet for renal
disease (MDRD) formula < 15 mL/min/1.73 m2 at Month 27 of Study AG10-301 or at any
subsequent central lab value prior to Day 1.

7. Known hypersensitivity to acoramidis, its metabolites, or formulation excipients.

8. At the end of Study AG10-301 or at Day 1 of Study AG10-304 (or any time during the
study), participant is on prohibited medication.

9. Females who are pregnant or breastfeeding. A negative urine pregnancy test at the Day
1 visit and at each study visit are required for female participants of childbearing
potential.

10. In the judgment of the Investigator or Medical Monitor, has any clinically important
ongoing medical condition or laboratory abnormality or condition that might jeopardize
the participant's safety, increase their risk from participation, or interfere with
the study.

11. Participation in another interventional clinical trial (with the exception of Study
AG10-301) within 30 days prior to dosing. Participation in observational and/or
registry studies should be discussed with the Medical Monitor.

12. Has any condition that in the opinion of the Investigator or Medical Monitor would
preclude compliance with the study protocol such as a history of substance abuse,
alcoholism, or a psychiatric condition.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/24/22. Questions regarding updates should be directed to the study team contact.