Pharma company cuts death rates by 70% in ALS trial :: InvestMacro


source: Streetwise Reports 07/15/2022

Clene Inc. shares have been traded. Up 38% yesterday after the company reported that CNM-Au8 had shown a significant reduction in mortality in its RESCUE-ALS long-term extension trial.

Along with its wholly owned subsidiary, Clene Nanomedicine Inc. , a biopharmaceutical company in the clinical stage Clin Corporation (CLNN: NASDAQ)which focuses on developing therapies designed to restore and protect the health and function of neurons in the treatment of neurodegenerative diseases, yesterday announce “Significantly improved survival in ALS patients initially treated with CNM-Au8 compared to participants initially randomized to placebo during the long-term open-label extension of the RESCUE-ALS trial.”

Clene President and CEO Rob Etherington commented, “We are very pleased to see these results and the clear survival benefit that our experimental drug CNM-Au8 appears to offer to people with ALS… At this point, we are awaiting first-line data from The HEALEY ALS Platform Trial, which focuses on endpoints that measure patient function, survival and respiration over six months in a much larger cohort.Clene Inc. expects to announce these results this quarter.Based on the largest number of patients treated in the trial HEALEY 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, 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 completion of the initial period, evaluation was continued for an open-label period in which patients received extended treatment for up to 130 weeks from the initial date of randomization.



The company advised that the interim data presented in yesterday’s release was based on a cut-off on July 5, 2022, and that survival rates were analyzed based on those in the treatment group versus the control group at various time points.

The company reported survival data and noted that two study participants, one from each group, were lost to follow-up. The company stated that during the trial, five deaths occurred in the group randomized to receive CNM-Au8 and 14 deaths were recorded in the group originally randomized to receive placebo.

The company stated that “median survival from randomization to the CNM-Au8 group was not determined due to insufficient mortality events, and the median survival for the placebo group was 23.1 months.” Although results from Kaplan-Meier’s unadjusted survival analyzes “demonstrated a significant survival benefit with participants initially randomized to CNM-Au8 treatment versus those initially randomized to placebo, resulting in Reduced risk of death by 70%.”

Clean Inc. is a clinical-stage biopharmaceutical company headquartered in Salt Lake City, Utah, with research, development, and manufacturing operations in Maryland. The company seeks to revolutionize the treatment of neurodegenerative diseases by focusing on targeting energy failure, which it has shown is an underlying cause of many neurodegenerative diseases.

The company is using its nanomedicine platform to create a pipeline of clean-surface and catalytically effective nanocrystals for therapeutic use. The company described CNM-Au8® as “an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization.”

Clene started the day with a market capitalization of approximately $182.1 million with approximately 63.3 million shares outstanding and a short interest rate of approximately 4.0%. CLNN shares opened close to 8% higher Thursday at $3.10 (+$0.22, +7.64%) from the closing price of $2.88.

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