Together with its wholly owned subsidiary Clene Nanomedicine Inc., clinical-stage biopharmaceutical company Clene Inc. (CLNN:NASDAQ), which is focused on developing treatments designed to restore and protect neuronal health and function in the treatment of neurodegenerative diseases, yesterday announced "significantly improved survival in ALS patients initially treated with CNM-Au8 compared to initially randomized placebo-treated participants during the long-term open-label extension of its RESCUE-ALS trial."
Clene's President and CEO Rob Etherington commented, "We are very pleased to see these results and the apparent survival benefit that our investigational drug, CNM-Au8, appears to provide to people living with ALS…At this point, we are awaiting top-line data from the HEALEY ALS Platform Trial, which focuses on endpoints measuring patient function, survival, and breathing over a six-month period in a much larger cohort. Clene Inc. expects to announce these results this quarter. Based on the larger number of patients treated in the HEALEY trial and the higher dose of CNM-Au8 being tested, we are optimistic that we will be able to adequately characterize the effects of our drug on this devastating disease."
The company advised that the RESCUE-ALS trial enrolled a total of 45 participants in the double-blind portion of the study. During this phase, one-half (n-23) of the enrollees were given a daily dose of 30 mg of CNM-Au8 over a 36-week period with the remaining half (n-22) receiving a placebo. After completing the initial period, evaluation continued for an open-label period where patients received extended treatment for up to 130 weeks from the initial date of randomization.
The firm advised that the interim data presented in yesterday's release was based upon a cut-off of July 5, 2022, and that survival rates were analyzed based on those in the treatment group versus the control group at various elapsed time points.
The company reported survival data and noted that two participants in the study, one from each group, was lost to follow-up. The firm stated that during the trial a total of five deaths occurred in the group that was randomized to receive CNM-Au8 and 14 deaths were recorded in the group that was originally randomized to be administered a placebo.
The company stated that "median survival from randomization for the CNM-Au8 group was undefined due to insufficient mortality events, and median survival for the placebo group was 23.1 months." The firm did say though that the results from the unadjusted Kaplan-Meier survival analyses "demonstrated a significant survival benefit with participants initially randomized to CNM-Au8 treatment versus those initially randomized to placebo, resulting in a 70% decreased risk of death."
Clene Inc. is a clinical-stage biopharma firm headquartered in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. The company endeavors to revolutionize treatment of neurodegenerative disease by focusing on targeting energetic failure, which it explained is an underlying cause of many neurological diseases.
The firm uses its nanotherapeutic platform to create a pipeline of clean-surfaced, catalytically-active nanocrystals for therapeutic use. The company described its CNM-Au8® as "an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization."
Clene began the day with a market cap of around $182.1 million with approximately 63.3 million shares outstanding and a short interest of about 4.0%. CLNN shares opened close to 8% higher Thursday at $3.10 (+$0.22, +7.64%) over its $2.88 closing price.
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