Business
Clene Reports Third Quarter 2021 Operating and Financial Highlights
Recently announced top-line results from RESCUE-ALS Phase 2 trial with CNM-Au8®, a gold nanocrystal suspensionVISIONARY-MS blinded interim data show
About this update from Clene Inc.
[{"type":"text","content":"Recently announced top-line results from RESCUE-ALS Phase 2 trial with CNM-Au8®, a gold nanocrystal suspensionVISIONARY-MS blinded interim data show clinically relevant improvements in the modified MS Functional Composite for the study population through 48 weeks of treatmentPhase 2 REPAIR program established central nervous system target engagement in people with MS and PD Results for Healey ALS Platform Trial expected in the second half of 2022Cash and restricted cash of $60.6 million as of September 30, 2021 SALT LAKE CITY, Nov. 09, 2021 (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 disease with its potential first-in-class catalytically active nanocrystal suspension, today reported its third quarter 2021 operating and financial results. “We believe that the top-line data from RESCUE-ALS, a Phase 2 proof-of-concept clinical trial evaluating CNM-Au8 as a disease modifying treatment for people with early ALS, indicate the potential of CNM-Au8 to benefit patients living with this debilitating and deadly disease. The results also provide further support in the ability of our nanotherapeutics to treat energetic failure, an underlying cause of many neurological diseases,” said Rob Etherington, President and CEO of Clene. “Based on these results, we look forward to reporting results from the Phase 2/3 HEALEY ALS Platform Trial, which we expect in the second half of 2022.” Third Quarter 2021 and Recent Highlights CNM-Au8 for the treatment of amyotrophic lateral sclerosis (ALS): Reported top-line results from RESCUE-ALS Phase 2 trial RESCUE-ALS is a Phase 2 clinical trial evaluating CNM-Au8 as a disease modifying treatment for people with early amyotrophic lateral sclerosis (ALS). This 36-week randomized, placebo-controlled trial enrolled 45 patients, randomized 1:1 to treatment with CNM-Au8 at 30 mg daily or matching placebo on top of standard of care. As previously announced, the trial did not meet the primary endpoint, change in MUNIX score at week 36. In this study, ALS patients with early bulbar-onset did not worsen in MUNIX, which measures lower motor neurons located in the spinal cord. In a pre-specified subset analysis of limb onset...