- The company is seeking an accelerated approval regulatory pathway for CNM-Au8® for ALS.
- The FDA agreed to an in-person meeting to reevaluate Clene’s submission.
- Lead drug candidate CNM-Au8 has been shown to restore and protect neurological function, offering hope for patients with neurodegenerative conditions.
- The FDA meeting will be held before the end of November and will be attended by top FDA officials and key opinion leaders in ALS, biostatistics and biomarkers.
Clene (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”), announced an upcoming meeting with the U.S. Food and Drug Administration (“FDA”) leadership to discuss lead candidate CNM-Au8®.
According to a company press release, the in-person meeting will be held before the end of November 2024 and will focus on the company’s CNM-Au8 biomarker and related clinical and survival data for ALS. The meeting will be attended by FDA’s Director of the Office on New Drugs, the Director of the Office of Neuroscience, and the Division of Neurology 1 (“DN1”) review team, as well as recognized key opinion leaders in ALS, biostatistics and biomarkers (https://ibn.fm/UgpSj).
The meeting comes after Clene submitted CNM-Au8 biomarker and clinical efficacy data to the FDA in a Type C meeting request, seeking approval to file a New Drug Application (“NDA”) using the accelerated approval regulatory pathway for ALS. DN1 responded that Clene’s briefing package for CNM-Au8 was not supportive of an NDA submission under the accelerated approval pathway. However, following further discussions, the FDA agreed to meet in person to reevaluate Clene’s submission.
“Clene looks forward to the opportunity to have experts present their views to the FDA and address questions on ALS biomarkers, related clinical endpoints and survival data, all of which Clene believes are essential for the understanding of its CNM-Au8,” the company release said.
The company also voiced appreciation for the FDA’s use of process and regulatory flexibility to obtain the best outcome for people living with ALS.
CNM-Au8 is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the nicotinamide adenine dinucleotide (“NAD”) pathway while reducing oxidative stress.
An oral suspension of gold nanocrystals, CNM-Au8 works by improving cellular energy production and utilization, crucial for maintaining neuronal health. Mitochondrial dysfunction is a common pathway leading to neuronal death in neurodegenerative diseases. By targeting this dysfunction, CNM-Au8 aims to provide neuroprotection and promote remyelination, potentially altering the course of these debilitating conditions, providing a dual benefit that sets it apart from existing therapies.
Clene has conducted extensive clinical trials to evaluate the safety and efficacy of CNM-Au8. Two recent independently conducted Phase 2 clinical trials, RESCUE-ALS and HEALEY ALS Platform Trials, yielded encouraging results, as participants saw improvement in survival rates and delays in clinical worsening, defined as first occurrence of death (or death and permanent assisted ventilation), tracheostomy, need for invasive ventilatory support, or feeding tube placement.
Additionally, Clene has more than 700 patient-years of safety data that show no significant safety concerns or safety trends identified. No serious adverse events have been identified as related to CNM-Au8 treatment by any clinical trial investigators to date. CNM-Au8 has the potential to capture a significant share of the therapeutic market for both ALS and MS by working in conjunction with existing treatments to improve function and increase survival rates.
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://ibn.fm/CLNN
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