- The H.C. Wainwright 26th Annual Global Investment Conference is being held on-line and in person, Sept. 9-11.
- Clene management will give a virtual presentation of the company’s most recent achievements and results and will hold one-on-one investor meetings.
- Lead drug candidate CNM-Au8 has been shown to restore and protect neurological function, offering new hope for patients with neurodegenerative conditions.
- The company is seeking FDA approval to file a new drug application for CNM-Au8, using the accelerated approval pathway for treatment of ALS.
Clene (NASDAQ: CLNN), 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”), will present at the H.C. Wainwright 26th Annual Global Investment Conference.
During the Sept. 9-11 event, Clene management presented the company’s latest achievements and updates, including recent results and plans for lead candidate CNM-Au8. The company will also participate in one-on-one investor meetings. A webcast of the presentation is available with signup on the “Events” section of the Clene website (https://nnw.fm/ru8L7).
The unique mechanism of action of CNM-Au8 represents an intersection of innovations from material science and physics, applied to the treatment of neurodegenerative disorders. CNM-Au8, which is taken orally each morning, works by a catalytic mechanism to improve cellular energy production and utilization, a crucial step 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 conditions.
The company has conducted extensive clinical trials to evaluate the safety as well as the efficacy of CNM-Au8. Two recent independently conducted Phase 2 clinical trials, RESCUE-ALS and HEALEY ALS Platform Trials showed participants saw improvement in survival rates and delays in clinical worsening, defined as first occurrence of death (or death and need for permanent assisted ventilation), tracheostomy, need for invasive ventilatory support, or feeding tube placement.
With over 650 cumulative years of subject exposure, CNM-Au8 has shown a strong safety profile with no serious adverse events linked to the drug. CNM-Au8 hopes 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.
The company has already submitted CNM-Au8 biomarker and clinical efficacy data to the Food and Drug Administration in a Type C meeting request, seeking approval to file a New Drug Application (“NDA”) using the accelerated approval regulatory pathway for ALS. A response is expected in the third quarter of 2024. If this accelerated pathway is approved, the next steps will be to file an NDA by the end of the year and to launch a confirmatory global Phase 3 study in ALS.
Clene’s innovative approach, backed by strong intellectual property with over 150 patents worldwide, positions it as a leader in addressing neurodegenerative diseases. The anticipated FDA interactions and ongoing studies will be crucial steps towards potentially bringing a transformative treatment to patients suffering from these conditions.
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
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