But, which is the best?
• Some anti-beta amyloids (ABs) made it
⇒ thru pos Ph3
⇒ 1 full FDA approval
But lots of ABs have died in clinical trials!
• gantenerumab, bapineuzumab, solanezumab, etc.
⇒ Benefit vs. Risk = Efficacy vs. ARIA (brain swelling)
⇒ Precise binding props (& more?) are important 🫶
See comparison image (thx ABOS)
For those ABs that made it thru Ph3… which is best?
Lecanemab (Leqembi)
• Full FDA approval
• Eisai et al.
• Binding props:
⇒ Strongest: protofibrils
⇒ Some binding: oligomers & insoluble fibrils
• Symptomatic ARIA: 4%
• Efficacy*: -27%
• Commercial success?
Aducanumab (Aduhelm)
• Conditional FDA approval
• Eisai et al.
• Binding props:
⇒ Strongest: amyloid plaque
⇒ Other binding: protofibrils
• Symptomatic ARIA: 10-29%
• Efficacy*: -22%, +2%, -27%**
• Commercial & PR disaster!
Donanemab
• BLA filed?
⇒ Will confirm at #AAIC investor call next week?
• LLY
• Binding props:
⇒ Strongest: amyloid plaque
⇒ Other binding: None?
• Symptomatic ARIA: 6%
• Efficacy*: -36%
• Pre-commercial
⇒ Pos Phase 3
⇒ Will FDA approve full BLA?
Caution:
The table comparing ARIA and efficacy across Leqembi, Aduhelm, and donanemab is a cross-trial comparison.
There is some side-by-side data from LLY of donanemab and Aduhelm.
Brain amyloid plaque clearance @ 6 months:
37.9% for donanemab
1.6% for Aduhelm
ARIA comparison @ 6 months
Aduhelm: total ARIA = 26.1% ; Symptomatic = 4.3%
Donanemab: total ARIA = 25.4%; Sympt = 2.8%
all symptomatic was ARIA-E
More from this study likely at #AAIC23!
Footnotes:
Esai et al. = Eisai, $BIIB & BioArctic AB
*Efficacy = CDR-SB: more negative = BETTER
⇒ more slowing of cognitive decline
* More details on efficacy & ARIA = See data table 📷
** Inconsistent clinical results for aducanumab (especially ENGAGE trial)
Originally Published 7/15/23 (RB)
This is not investment, legal or tax advice. Do your own diligence and seek the advice of professionals.
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