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Clene to Announce New CNM-Au8 Data From the Healey ALS Platform Trial

Key Takeaway: Clene Inc. is announcing a live audio webcast to present new data from the CNM-Au8 arm of the Healey ALS Platform Trial, focusing on clinical results related to ALS treatment. The trial is a comprehensive, multi-center study assessing the safety and efficacy of CNM-Au8 in conjunction with standard care. The results are anticipated to shed light on the efficacy of the investigational product, which aims to enhance neuronal health through unique mechanisms. This webcast will take place on March 9, allowing investors and stakeholders to gain insights into the findings.

Market Sentiment Analysis

POSITIVE FACTORS

  • Clene is set to present new clinical results which may indicate progress in ALS treatment.
  • The Healey ALS Platform Trial is a large-scale, rigorous study design focused on safety and efficacy.
  • CNM-Au8 aims to restore neuronal health, which can lead to neuroprotection and improved patient outcomes.

Full Press Release Details

SALT LAKE CITY, March 08, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, announced today that it will host a live audio webcast at 7:30 a.m. ET tomorrow, Thursday, March 9, to review new clinical results from the CNM-Au8® arm of the Healey ALS Platform Trial. The Healey ALS Platform Trial was a multi-center, double-blind, placebo-controlled study to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of CNM-Au8 in treating ALS. The webcast is accessible via the link below or the Investors section of the Company’s website located at www.clene.com.
Webcast Information:
Title: Clene’s Healey ALS Platform Trial Data Update
Presenters: Clene & Merit Cudkowicz, M.D., Chief Neurology Department, Director, Sean M Healey & AMG Center for ALS, and the Principal Investigator of the Healey ALS Platform Trial
Start Time: 7:30 a.m. ET
The archived webcast will be available on the Company’s website beginning approximately two hours after the event.
About the Healey ALS Platform Trial
The HEALEY ALS Platform Trial is a perpetual multi-center, randomized, double-blind, placebo-controlled program designed to evaluate the efficacy and safety of multiple investigational products utilizing a shared placebo group in people living with amyotrophic lateral sclerosis (ALS). In the CNM-Au8 regimen, 161 participants were randomized to 30 mg CNM-Au8, 60 mg CNM-Au8, or placebo as adjunct to standard of care for a 24-week treatment period. Active drug was offered to all participants who were eligible and elected to continue into the open-label extension. The primary outcome of the trial was the change in disease severity over time as measured by ALSFRS-R through 24 weeks accounting for mortality (analyzed using a Bayesian shared parameter model). Prespecified secondary efficacy endpoints included the Combined Assessment of Function and Survival joint rank test (CAFS), change in respiratory function as measured by slow vital capacity (SVC), and overall survival. For more information, please see ClinicalTrials.gov Identifier: NCT04297683.
CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8 is a federally registered trademark of Clene Nanomedicine, Inc.

Frequently Asked Questions

When will Clene host the webcast on ALS trial results?

Clene will host the webcast on March 9, 2023, at 7:30 a.m. ET.

What is the focus of the Healey ALS Platform Trial?

The trial evaluates the safety and efficacy of treatments for ALS.

How many participants were involved in the CNM-Au8 study?

A total of 161 participants were randomized in the CNM-Au8 study.

What does CNM-Au8 aim to improve in patients?

CNM-Au8 is designed to enhance neuronal health and energy production.

Where can I access the webcast after the event?

The archived webcast will be available on Clene's website two hours later.

Last updated: Mar 8, 2023