Clene (NASDAQ: CLNN): A Promising Player in Neurodegenerative Disease Treatment

Clene Inc. (NASDAQ: CLNN) is a clinical-stage pharmaceutical company focusing on the discovery, development, and commercialization of novel clean-surfaced nanotechnology (CSN) therapeutics. With a strong pipeline and positive clinical data, Clene is well-positioned to capture a significant share of the market for neurodegenerative disease treatments.

Clene's CSN technology offers a novel approach to treating neurodegenerative diseases by targeting mitochondrial health and neuronal function. Unlike existing therapies that primarily focus on immune system modulation, Clene's CNM-Au8® has demonstrated significant improvements in clinical outcomes, physiologic measures, and structural evidence of repair and remyelination in multiple sclerosis (MS) patients. The technology's potential to improve neuronal function and promote remyelination has not been demonstrated by any other non-immunomodulatory drug in a Phase 2 clinical trial. Additionally, Clene's CSN technology has shown promise in treating amyotrophic lateral sclerosis (ALS), with lowered risk of death and delayed clinical worsening in Phase 2 studies.

Clene's Phase 2 VISIONARY-MS trial of CNM-Au8 demonstrated significant improvements in vision, cognition, and functional outcomes in patients with MS. Long-term extension data showed sustained improvement in low contrast letter acuity (up to 38 letters), cognition (up to 29 points on SDMT), and global neurological function (up to 1.4 units on mMSFC) through 35 months. These results, along with well-tolerated treatment and no serious adverse events, support CNM-Au8's potential as a promising therapy for MS.

The long-term extension studies of CNM-Au8 in both ALS and MS patients have yielded significant findings that support the drug's potential for long-term efficacy and safety. In the VISIONARY-MS trial, long-term CNM-Au8 treatment demonstrated significant and clinically meaningful improvement of vision and cognition through 35 months from randomization, with no serious adverse events attributed to the drug. Similarly, in the ACT-EAP for ALS, CNM-Au8 treatment has been associated with lowered risk of death and delayed clinical worsening, while being very well-tolerated. These results suggest that CNM-Au8 may offer long-term benefits for patients with neurodegenerative diseases, with a favorable safety profile.


Clene's focus on neurodegenerative diseases, a growing market with limited treatment options, further enhances its potential. With a strong pipeline and positive clinical data, Clene is well-positioned to capture a significant share of the market, making it an attractive investment opportunity.


In conclusion, Clene's CSN technology offers a promising approach to treating neurodegenerative diseases, with strong clinical data supporting its potential for long-term efficacy and safety. As the company continues to advance its pipeline and expand its market presence, investors should consider Clene as a potential addition to their portfolios.