ALS data comp: Clene’s NfL reduction vs. Biogen’s
As Clene explores NDA submission, BioCentury benchmarks its NfL data against that of the sole ALS drug with accelerated approval
When Clene’s therapy missed the primary endpoint in the HEALEY ALS platform trial, HEALEY Director Merit Cudkowicz argued that the results of a prespecified survival analysis warranted additional study of the drug. With Thursday’s announcement that CNM-Au8 had a statistically significant effect on plasma NfL in the platform study, the question now is whether the additional study could be pushed to the postmarket setting.
In light of the NfL readout, which comes nine months after the primary endpoint results were reported, the Clene Nanomedicine unit of Clene Inc. (NASDAQ:CLNN) said it is “exploring the possibility for a NDA filing” for CNM-Au8 based on the biomarker...