Key Takeaways from Our ATTR-CM Expert Call

Research evidence excerpt

Key Takeaways from Our ATTR-CM Expert Call

sed patient awareness BBIO 67.61

of its data, while tafamidis use may be pressured by pharmacy / statin interaction

alerts and payer driven switches to Attruby. Increasingly, there seems to be increased INDUSTRY RISKS

awareness of the statin interaction with tafamidis as this is the 2nd KOL that has Risks include clinical, regulatory, commercial

acknowledged this interaction. and financing related risks.

• New patient diagnosis rates are increasing and the KOL expects this trend to

accelerate materially over the next five years. The KOL estimates the field is currently

diagnosing only 30-45% of prevalent ATTR-CM patients, with a consensus estimate

of ~60-70K currently diagnosed in the US and a potential for an additional ~150K

diagnoses over the next five years. The KOL's confidence in this estimate is anchored

by the observation that virtually every patient they see already has established amyloid

at presentation (>90% have advanced disease at first referral), suggesting a large

undiagnosed pool presenting late. Furthermore, KOL mentioned a novel diagnostic

being developed by Bayer (XETRA: BAYN-DE) that reported Ph3 data from the REVEAL

trial that met primary endpoints of sensitivity and specificity for the diagnosis of cardiac

amyloidosis. Bayer's 124I-evuzamitide is a synthetic peptide that binds directly to all

types of amyloid fibrils (AL and ATTR) and can detect amyloid deposits earlier compared

to the current PYP diagnostic. The KOL also mentioned referral volumes are growing,

with 10-15% of monthly visits representing new diagnoses, 30-35% return patients, and

still a significant portion of misdiagnoses. The KOL also noted that mortality rates have