Clene To Provide Key Update On CNM-Au8 In Amyotrophic Lateral Sclerosis

(RTTNews) - Clene Inc. (CLNN) is scheduled to provide an update on its CNM-Au8 program in amyotrophic lateral sclerosis on Wednesday, December 3, 2025.

CNM-Au8, the company's lead drug candidate, is a gold nanocrystal suspension currently in development as a disease-modifying treatment for people living with Amyotrophic Lateral Sclerosis, Multiple Sclerosis, and Parkinson's Disease.

A phase 2/3 multi-centre, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of Amyotrophic Lateral Sclerosis, dubbed HEALEY ALS Platform Trial, is underway. Regimen C of this trial is evaluating the safety and efficacy of CNM-Au8 in participants with ALS.

Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease that affects motor neurons - the nerve cells in the brain and spinal cord that control voluntary muscle movement.

Results of the HEALEY ALS Platform Trial, published online in the peer-reviewed medical journal JAMA this February, concluded that CNM-Au8 did not improve the primary efficacy outcome of ALS disease progression measured over 24 weeks.

A post-hoc analysis of long-term survival data from the HEALEY ALS Platform Trial, covering up to 48 months of follow-up and released in March, showed evidence of a significant survival advantage with CNM-Au8. According to the findings, the CNM-Au8 30 mg group achieved a median survival of 951 days, compared to 753 days in the Regimen A (Zilucoplan) comparator group, representing a gain of 198 days (6.5 months).

In line with the FDA's recommendations, Clene is concluding analyses of its ALS biomarker data, with completion planned shortly.

If all goes well as planned, the company plans to submit a New Drug Application for CNM-Au8 in ALS in the first quarter of 2026 under an accelerated approval pathway.

CLNN has traded in a range of $2.28 to $13.50 in the last 1 year. The stock closed yesterday's trading at $9.26, down 3.14%.