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Clene Announces New CNM-Au8® Biomarker and Clinical Efficacy Data Submitted to FDA In Support of Treatment For ALS
Clene Inc. (Nasdaq: CLNN) has submitted new CNM-Au8 biomarker and clinical efficacy data to the FDA for ALS treatment. Key findings include:
1. CNM-Au8 NfL Responders showed significant improvements in survival, functional status, and combined function and survival.
2. Long-term CNM-Au8 treatmentdemonstrated substantial survival benefits compared to matched controls.
3. NAD and glutathione improvementswere consistent with CNM-Au8 treatment, supporting its dual mechanism of action.
4. Safety profile remains strong with no significant concerns identified over 650 patient years of data.
These results aim to support discussions with the FDA for an accelerated approval pathway for CNM-Au8 in ALS treatment.
1. CNM-Au8 NfL Responders showed significant improvements in survival, functional status, and combined function and survival.
2. Long-term CNM-Au8 treatmentdemonstrated substantial survival benefits compared to matched controls.
3. NAD and glutathione improvementswere consistent with CNM-Au8 treatment, supporting its dual mechanism of action.
4. Safety profile remains strong with no significant concerns identified over 650 patient years of data.
These results aim to support discussions with the FDA for an accelerated approval pathway for CNM-Au8 in ALS treatment.
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