Clene says ALS biomarker analyses show CNM-Au8 survival benefit in NfL responders
CLNN•Post hoc biomarker analyses support NDA filing
Clene disclosed new post hoc biomarker analyses from two Phase 2 ALS trials to support an accelerated-approval NDA for CNM-Au8.
The analyses were newly announced today and will be included in the NDA planned for filing in early Q4.
Survival and function benefits concentrated in biomarker responders
Patients whose nerve-injury biomarker levels declined or stabilized on CNM-Au8 showed better survival and function than controls.
Benefits were concentrated in biomarker responders; patients without a biomarker response did not show a clear advantage.
A planned Phase 3 confirmatory trial, RESTORE-ALS, will test the biomarker-to-benefit relationship prospectively.
