Clene Inc. (NASDAQ: CLNN) Announces Plan to Submit Briefing Book to FDA Preceding Type C Interaction
- Clene plans to submit a briefing book to the U.S. Food and Drug Administration by July 13 as Part of Overall Process to Support Approval for CNM-Au8(R) for Treatment of ALS
- Type C interaction is aimed at obtaining FDA feedback on the potential pathway for a new drug application for CNM-Au8 as a treatment for ALS via the accelerated approval process
- The briefing book includes new post-hoc analyses of data from completed clinical trials and addresses comments made by the FDA during a previous meeting in late 2023
Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company dedicated to enhancing mitochondrial health and protecting neuronal function to combat neurodegenerative diseases such as amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), have revealed plans to submit a briefing book to the U.S. Food and Drug Administration (“FDA”) by July 13. This submission precedes a granted Type C interaction scheduled for the third quarter of 2024, aimed at obtaining FDA feedback on the potential pathway for a new drug application (“NDA”) for CNM-Au8 as a treatment for ALS via the accelerated approval process (https://nnw.fm/aWOo3 ).
CNM-Au8, Clene’s primary therapeutic asset, is a highly concentrated aqueous suspension of catalytically active, clean-surfaced, faceted gold nanocrystals. Neurodegenerative diseases often involve multiple pathogenic factors leading to neuronal death, with mitochondrial dysfunction and NAD+ decline being critical pathways. NAD+ is essential for cell survival and function. CNM-Au8’s catalytic mechanisms are designed to address the energy deficits, oxidative stress, and accumulation of misfolded proteins typical in many neurodegenerative diseases.
The briefing book includes new post-hoc analyses of data from completed clinical trials and addresses comments made by the FDA during a previous meeting in late 2023. In that meeting, Clene received guidance on the potential for accelerated approval. The briefing book provides additional analyses on the reduction of the neurofilament light (“NfL”) biomarker, a more comprehensive set of survival and functional benefit data, and further evidence of CNM-Au8’s mechanism of action.
Clene believes that these analyses collectively support the accelerated approval based on NfL reduction as a surrogate endpoint. Moreover, the company has included data to address the FDA’s request for more information on the relationship between CNM-Au8’s proposed mechanism of action and NfL reduction, as well as the link between observed NfL reductions and improved clinical outcomes in ALS patients, including survival rates.
The unique mechanism of action of CNM-Au8 is believed to provide neuroprotection and support remyelination in neurodegenerative conditions by: (1) promoting and maintaining beneficial metabolic and energetic cellular reactions in diseased, stressed, or damaged cells, (2) catalyzing the reduction of harmful reactive oxygen species (“ROS”), and (3) enhancing protein homeostasis through activation of the heat shock factor-1 pathway. This pathway helps reduce the cytotoxicity caused by misfolded and denatured proteins, which are common in neurodegenerative diseases.
CNM-Au8, used in combination with other treatments, has no known drug-drug interactions and aims to improve function and survival. Clinical trials for ALS have demonstrated its positive effects on both function and survival, as previously reported.
In clinical trials and Expanded Access Protocol programs for ALS, MS, and Parkinson’s disease, CNM-Au8 has been collectively used for over 500 estimated years without any reported safety concerns.
The neurodegenerative disease market size is estimated at $55.12 billion in 2024 and is expected to reach $77.82 billion by 2029, growing at a CAGR of 7.14% during the forecast period. This growth can be attributed to the increase in number of neurological disorder diagnoses, the growing awareness globally, and the lineup of products being developed for treatment (https://nnw.fm/cSFco ).
Further details on these new data analyses will be shared publicly later in 2024. Clene plans to publicly announce the FDA’s feedback following the completion of the Type C interaction.
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 plans to submit a briefing book to the U.S. Food and Drug Administration by July 13 as Part of Overall Process to Support Approval for CNM-Au8(R) for Treatment of ALS
- Type C interaction is aimed at obtaining FDA feedback on the potential pathway for a new drug application for CNM-Au8 as a treatment for ALS via the accelerated approval process
- The briefing book includes new post-hoc analyses of data from completed clinical trials and addresses comments made by the FDA during a previous meeting in late 2023
Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company dedicated to enhancing mitochondrial health and protecting neuronal function to combat neurodegenerative diseases such as amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), have revealed plans to submit a briefing book to the U.S. Food and Drug Administration (“FDA”) by July 13. This submission precedes a granted Type C interaction scheduled for the third quarter of 2024, aimed at obtaining FDA feedback on the potential pathway for a new drug application (“NDA”) for CNM-Au8 as a treatment for ALS via the accelerated approval process (https://nnw.fm/aWOo3 ).
CNM-Au8, Clene’s primary therapeutic asset, is a highly concentrated aqueous suspension of catalytically active, clean-surfaced, faceted gold nanocrystals. Neurodegenerative diseases often involve multiple pathogenic factors leading to neuronal death, with mitochondrial dysfunction and NAD+ decline being critical pathways. NAD+ is essential for cell survival and function. CNM-Au8’s catalytic mechanisms are designed to address the energy deficits, oxidative stress, and accumulation of misfolded proteins typical in many neurodegenerative diseases.
The briefing book includes new post-hoc analyses of data from completed clinical trials and addresses comments made by the FDA during a previous meeting in late 2023. In that meeting, Clene received guidance on the potential for accelerated approval. The briefing book provides additional analyses on the reduction of the neurofilament light (“NfL”) biomarker, a more comprehensive set of survival and functional benefit data, and further evidence of CNM-Au8’s mechanism of action.
Clene believes that these analyses collectively support the accelerated approval based on NfL reduction as a surrogate endpoint. Moreover, the company has included data to address the FDA’s request for more information on the relationship between CNM-Au8’s proposed mechanism of action and NfL reduction, as well as the link between observed NfL reductions and improved clinical outcomes in ALS patients, including survival rates.
The unique mechanism of action of CNM-Au8 is believed to provide neuroprotection and support remyelination in neurodegenerative conditions by: (1) promoting and maintaining beneficial metabolic and energetic cellular reactions in diseased, stressed, or damaged cells, (2) catalyzing the reduction of harmful reactive oxygen species (“ROS”), and (3) enhancing protein homeostasis through activation of the heat shock factor-1 pathway. This pathway helps reduce the cytotoxicity caused by misfolded and denatured proteins, which are common in neurodegenerative diseases.
CNM-Au8, used in combination with other treatments, has no known drug-drug interactions and aims to improve function and survival. Clinical trials for ALS have demonstrated its positive effects on both function and survival, as previously reported.
In clinical trials and Expanded Access Protocol programs for ALS, MS, and Parkinson’s disease, CNM-Au8 has been collectively used for over 500 estimated years without any reported safety concerns.
The neurodegenerative disease market size is estimated at $55.12 billion in 2024 and is expected to reach $77.82 billion by 2029, growing at a CAGR of 7.14% during the forecast period. This growth can be attributed to the increase in number of neurological disorder diagnoses, the growing awareness globally, and the lineup of products being developed for treatment (https://nnw.fm/cSFco ).
Further details on these new data analyses will be shared publicly later in 2024. Clene plans to publicly announce the FDA’s feedback following the completion of the Type C interaction.
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
