Open-Label Study of AG10 in Patients With Cardiomyopathy

Prior treatment

• Receiving current treatment with diflunisal, tafamidis, green tea, doxycycline, TUDCA/Ursodiol, patisiran, inotersen or any other investigational ATTR agent within 14 days or 5 half-lives of the prior investigational agent (whichever is longer) prior to dosing with study drug.
• Females who are pregnant or breastfeeding. Lactating females must agree to discontinue nursing before the study drug is administered. Negative urine pregnancy test at each visit is required for female patients of childbearing potential.

Other illness

• Known hypersensitivity to study drug (acoramidis), its metabolites, or formulation excipients.
• Likely to undergo heart transplantation or placement of a mechanical circulatory device within the next year.

Lab values

• Hemodynamic instability that would pose too great a risk to the subject based on screening laboratory results from study AG10-201.
• Abnormalities in clinical laboratory tests that would pose too great a risk to the subject based on screening laboratory results from study AG10-201.
• Any clinically significant ongoing medical condition or any laboratory abnormality or condition that could adversely affect the safety of the patient.

• Completed the study AG10-201.
• Willing and able to comply with the study medication regimen and all other study requirements based on screening laboratory results from study AG10-201.
• The ability to understand and provide informed consent, which must be obtained prior to initiation of study participation based on screening laboratory results from study AG10-201.
• Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use effective method(s) of contraception.