other material
confidence high
sentiment positive
materiality 0.85
Clene reports significant survival benefit with CNM-Au8 in ALS compassionate use programs
Clene Inc.
- 68% decreased risk of all-cause mortality vs PRO-ACT matched controls (HR=0.320, p=0.0001).
- 57% decreased risk of all-cause mortality vs ALS Natural History Consortium matched controls (HR=0.433, p=0.0001).
- Data from 256 EAP participants (220 matched); no serious adverse events attributed to CNM-Au8.
- Results support advancing CNM-Au8 to Phase 3 testing in ALS; $45.1M NIH grant for third EAP.
- CNM-Au8 30 mg well-tolerated with up to 4 years of dosing; EAP enrollment in H1 2024 planned.