Clene Inc. (NASDAQ: CLNN) Leverages APST’s NfL Database to Support FDA-Recommended Analyses for ALS Drug
- Clene is partnering with APST Research GmbH to analyze neurofilament light chain (“NfL”) data for evaluating CNM-Au8® in ALS patients.
- APST maintains one of the largest ALS biomarker databases, with data from over 4,300 ALS patients, including clinical outcomes and biomarker tracking.
- The analysis will compare NfL changes in the NIH-sponsored Expanded Access Program (“EAP”) participants with historical ALS patient data to assess CNM-Au8’s potential efficacy.
- Clene plans to submit its statistical analysis plan to the FDA, aiming for filing of an NDA for potential accelerated approval in the second half of 2025.
- No significant safety concerns have been reported across over 800 participant years of CNM-Au8 treatment.
Clene Inc. (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), has signed an agreement with APST Research GmbH (“APST”) to support analyses of CNM-Au8’s effects on NfL decline in participants in ongoing EAPs (https://nnw.fm/a9TFw ). The analyses were recommended by the U.S. Food and Drug Administration (“FDA”) to support Clene’s data package for a potential accelerated approval application.
Based in Germany, APST operates one of the largest ALS biomarker repositories, with data on over 4,300 ALS patients, including demographic information, motor function, and NfL biomarkers. This collaboration will provide Clene with robust comparative data to assess CNM-Au8’s potential efficacy in reducing NfL levels. Neurofilament light chain is a well-established biomarker for neuronal damage. In ALS, elevated NfL levels indicate disease progression and neuronal degeneration. Tracking how NfL levels change over time provides insight into whether a drug is slowing disease progression.
Under this agreement, Clene will use APST’s extensive dataset to compare NfL levels in NIH EAP participants treated with CNM-Au8 against historical ALS controls. The NfL dataset Clene is analyzing includes data from more than 1,625 ALS patients, aligning the biomarker data of NfL to clinical ALSFRS-R assessments, slow vital capacity (“SVC”), and clinical events such as ventilation support and nutrition intervention. The goal is to determine if CNM-Au8 treatment reduces NfL decline, and to demonstrate that the rate of NfL change is associated with survival in people living with ALS, which could strengthen Clene’s case for regulatory approval.
Commenting on the agreement, APST’s founder and CEO Thomas Meyer, a renowned ALS key opinion leader, emphasized the value of real-world biomarker data, noting that the collaboration advances ALS research and clinical development. “Our extensive and robust data collection empowers pharmaceutical companies to advance their clinical research and trials, driving us toward a deeper understanding of ALS disease progression” Meyer said.
Clene has provided CNM-Au8 treatment to nearly 500 ALS patients through its three EAP programs, collecting real-world evidence to assess the drug’s impact. Key aspects of Clene’s NfL analysis plan to be submitted to the FDA include:
Comparing NfL changes in NIH-sponsored EAP participants to control data from APST.
Analyzing correlations between NfL levels and patient survival rates.
Supporting the case for FDA accelerated approval of CNM-Au8 in ALS treatment.
Clene plans to submit a new drug application (“NDA”) to the FDA in the second half of 2025 for potential accelerated approval. The NDA will contain data on NfL changes and survival with CNM-Au8 treatment, including results of this study.
CNM-Au8 is an oral suspension of gold nanocrystals designed to improve cellular energy production and utilization, which is critical for maintaining neuronal health. The drug candidate has been shown to improve central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the nicotinamide adenine dinucleotide pathway while reducing oxidative stress. By targeting mitochondrial dysfunction, CNM-Au8 can provide neuroprotection and promote remyelination. Across 800 participant years of CNM-Au8 treatment, no significant safety concerns or adverse events have been reported. Investigators have not identified any serious adverse events linked to the treatment.
“We are excited to enter into this endeavor with one of the world’s largest ALS NfL datasets in order to supplement available biomarker NfL data from our NIH-sponsored EAP, and to support the existing clinical study data for the potential review of an application for approval of CNM-Au8 in ALS via an accelerated regulatory pathway,” said Clene’s CEO, Rob Etherington. “We remain dedicated to the ALS community and are honored to continue our efforts to help critically ill patients and their families.”
For more information, visit the company’s website at www.Clene.com.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://nnw.fm/CLNN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
- Clene is partnering with APST Research GmbH to analyze neurofilament light chain (“NfL”) data for evaluating CNM-Au8® in ALS patients.
- APST maintains one of the largest ALS biomarker databases, with data from over 4,300 ALS patients, including clinical outcomes and biomarker tracking.
- The analysis will compare NfL changes in the NIH-sponsored Expanded Access Program (“EAP”) participants with historical ALS patient data to assess CNM-Au8’s potential efficacy.
- Clene plans to submit its statistical analysis plan to the FDA, aiming for filing of an NDA for potential accelerated approval in the second half of 2025.
- No significant safety concerns have been reported across over 800 participant years of CNM-Au8 treatment.
Clene Inc. (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), has signed an agreement with APST Research GmbH (“APST”) to support analyses of CNM-Au8’s effects on NfL decline in participants in ongoing EAPs (https://nnw.fm/a9TFw ). The analyses were recommended by the U.S. Food and Drug Administration (“FDA”) to support Clene’s data package for a potential accelerated approval application.
Based in Germany, APST operates one of the largest ALS biomarker repositories, with data on over 4,300 ALS patients, including demographic information, motor function, and NfL biomarkers. This collaboration will provide Clene with robust comparative data to assess CNM-Au8’s potential efficacy in reducing NfL levels. Neurofilament light chain is a well-established biomarker for neuronal damage. In ALS, elevated NfL levels indicate disease progression and neuronal degeneration. Tracking how NfL levels change over time provides insight into whether a drug is slowing disease progression.
Under this agreement, Clene will use APST’s extensive dataset to compare NfL levels in NIH EAP participants treated with CNM-Au8 against historical ALS controls. The NfL dataset Clene is analyzing includes data from more than 1,625 ALS patients, aligning the biomarker data of NfL to clinical ALSFRS-R assessments, slow vital capacity (“SVC”), and clinical events such as ventilation support and nutrition intervention. The goal is to determine if CNM-Au8 treatment reduces NfL decline, and to demonstrate that the rate of NfL change is associated with survival in people living with ALS, which could strengthen Clene’s case for regulatory approval.
Commenting on the agreement, APST’s founder and CEO Thomas Meyer, a renowned ALS key opinion leader, emphasized the value of real-world biomarker data, noting that the collaboration advances ALS research and clinical development. “Our extensive and robust data collection empowers pharmaceutical companies to advance their clinical research and trials, driving us toward a deeper understanding of ALS disease progression” Meyer said.
Clene has provided CNM-Au8 treatment to nearly 500 ALS patients through its three EAP programs, collecting real-world evidence to assess the drug’s impact. Key aspects of Clene’s NfL analysis plan to be submitted to the FDA include:
Comparing NfL changes in NIH-sponsored EAP participants to control data from APST.
Analyzing correlations between NfL levels and patient survival rates.
Supporting the case for FDA accelerated approval of CNM-Au8 in ALS treatment.
Clene plans to submit a new drug application (“NDA”) to the FDA in the second half of 2025 for potential accelerated approval. The NDA will contain data on NfL changes and survival with CNM-Au8 treatment, including results of this study.
CNM-Au8 is an oral suspension of gold nanocrystals designed to improve cellular energy production and utilization, which is critical for maintaining neuronal health. The drug candidate has been shown to improve central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the nicotinamide adenine dinucleotide pathway while reducing oxidative stress. By targeting mitochondrial dysfunction, CNM-Au8 can provide neuroprotection and promote remyelination. Across 800 participant years of CNM-Au8 treatment, no significant safety concerns or adverse events have been reported. Investigators have not identified any serious adverse events linked to the treatment.
“We are excited to enter into this endeavor with one of the world’s largest ALS NfL datasets in order to supplement available biomarker NfL data from our NIH-sponsored EAP, and to support the existing clinical study data for the potential review of an application for approval of CNM-Au8 in ALS via an accelerated regulatory pathway,” said Clene’s CEO, Rob Etherington. “We remain dedicated to the ALS community and are honored to continue our efforts to help critically ill patients and their families.”
For more information, visit the company’s website at www.Clene.com.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://nnw.fm/CLNN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
