Clene Inc. (NASDAQ: CLNN) Reveals Important Findings From HEALEY ALS Platform Trial

  • Clene presented findings on HEALEY ALS at the European Network for the Cure of ALS (ENCALS) meeting held in Stockholm, Sweden
  • The presentation, titled “Long-Term CNM-Au8(R) Treatment Reduces Neurofilament Light Levels and Improves Survival: Results from the HEALEY ALS Platform Trial,” showcased survival follow-up data
  • CNM-Au8 was found to be safe and well-tolerated during the OLE

Clene (NASDAQ: CLNN), through its wholly owned subsidiary, Clene Nanomedicine Inc., is a clinical-stage biopharmaceutical company dedicated to enhancing mitochondrial health and safeguarding neuronal function to combat neurodegenerative diseases such as amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). This week, Clene unveiled new and important long-term findings regarding CNM-Au8 treatment’s impact on survival rates and neurofilament light (“NfL”) levels from the HEALEY-ALS Platform Trial open label extension (“OLE”) at the European Network for the Cure of ALS (ENCALS) meeting held in Stockholm, Sweden (https://ibn.fm/xGfss).

The presentation, titled “Long-Term CNM-Au8 Treatment Reduces Neurofilament Light Levels and Improves Survival: Results from the HEALEY ALS Platform Trial,” showcased survival follow-up data extending up to 42 months (3.5 years) and long-term NfL biomarker results over 76 weeks. Analyses included identification of a subset of NfL-responders from the HEALEY ALS Platform Trial. The survival analysis encompassed all participants treated with CNM-Au8 30 mg, including those initially given a placebo who later transitioned to CNM-Au8 in the OLE, provided they had complete baseline co-variates.

The survival analysis included participants originally randomized to receive CNM-Au8 30 mg (n=59) and those who transitioned from placebo to CNM-Au8 (n=11). These groups were compared to matched controls from the PRO-ACT clinical trial database over a follow-up period of up to 3.5 years post-baseline.

  • CNM-Au8 30 mg treated patients exhibited approximately a 60% reduction in the risk of death compared to matched PRO-ACT controls over the 3.5-year follow-up period
  • The covariate-adjusted hazard ratio was 0.431 (95% CI: 0.276-0.672), with a p-value of 0.0002

A subset analysis identified NfL responders: participants showing consistent NfL declines (n=55). Responders were defined as those having all post-baseline measures with either an NfL decrease or repeated declines of at least 10 pg/mL following the commencement of CNM-Au8 treatment.

  • Responders demonstrated an average NfL reduction of 28%, suggesting a therapeutic protection against continued axonal loss
  • The geometric mean ratio (“GMR”) at Week 76 compared to baseline was 0.72 (95% CI: 0.67 – 0.79), with a p-value of less than 0.0001

These NfL results stem from previously announced analyses of plasma NfL collected from participants (n=99) in the HEALEY OLE who received CNM-Au8 30 mg up to week 76, compared to those initially on placebo for 24 weeks before switching to active treatment for up to 52 weeks. The analysis of long-term treatment with CNM-Au8 30 mg to week 76 demonstrated that CNM-Au8 continued to significantly reduce plasma NfL levels. The GMR versus placebo at week 76 was 0.841 (95% CI: 0.73 – 0.98), with a p-value of 0.023.

Furthermore, CNM-Au8 was found to be safe and well-tolerated during the OLE.

“The clinical evidence of plasma neurofilament reduction, as well as the long-term improved survival results up to 3.5 years compared to an established multi-study ALS dataset of more than 12,000 patients across multiple clinical centers provides further evidence to strongly support CNM-Au8 as a potential treatment for ALS,” said Dr. Benjamin Greenberg, Head of Medical at Clene.

The full poster is available for viewing in the Scientific Posters & Presentations section of the Clene website https://ibn.fm/njSux).

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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