CNM-Au8

When investigational amyotrophic lateral sclerosis (ALS) therapy CNM-Au8 reaches the bloodstream, it attracts a layer of proteins called a corona to its surface that help it more easily reach the brain and last longer in circulation, according to recent research. Developer Clene Nanomedicine says the findings are consistent…

Treatment with CNM-Au8 was shown to significantly prolong survival — relative to the natural history of the disease — among people with advanced amyotrophic lateral sclerosis (ALS) who took part in two expanded access programs (EAP), also known as compassionate use programs. The findings from these EAPs, which…

Early data from Phase 2 programs showing that CNM-Au8, an oral therapy candidate for amyotrophic lateral sclerosis (ALS), induced significant reductions in a nerve damage biomarker but did not meet the criteria for accelerated approval at this time, the U.S. Food and Drug Administration (FDA) concluded. Despite the…

The National Institutes of Health (NIH) has awarded about $45.1 million toward an expanded access program (EAP) of CNM-Au8, an oral therapy candidate for amyotrophic lateral sclerosis (ALS). The EAP, commonly referred to as compassionate use, will make CNM-Au8 available to U.S. patients who aren’t eligible for clinical…

Up to about 2.5 years of treatment with CNM-Au8 in an open-label extension of the HEALEY ALS platform trial significantly reduced the risk of death for individuals with amyotrophic lateral sclerosis (ALS) relative to a historical placebo group of patients from previous ALS clinical trials, according to new…

Treatment with CNM-Au8 was found to significantly delay disease progression and prolong survival, by more than 1.5 years, among adults with early-stage amyotrophic lateral sclerosis (ALS) in the RESCUE-ALS trial and its open-label extension phase. That’s according to two different statistical analyses, which overall showed that patients who…

CNM-Au8 extended long-term survival and slowed disease progression in adults with early stage amyotrophic lateral sclerosis (ALS) compared with a placebo, according to final data from the RESCUE-ALS clinical trial and one-year findings in its open-label extension (OLE). Patients treated initially with CNM-Au8 in the main trial experienced…

Treatment with CNM-Au8 significantly delayed clinical worsening in people with amyotrophic lateral sclerosis (ALS), according to new exploratory analyses from the therapy’s arm of the HEALEY ALS platform trial. The experimental therapy, from Clene Nanomedicine, had previously been found to reduce the risk of death by more…

Amyotrophic lateral sclerosis (ALS) patients treated earlier with CNM-Au8 in a clinical trial experienced a significantly slower disease progression than those who started treatment nine months later. These latest findings from the RESCUE-ALS Phase 2 trial (NCT04098406) and its open-label extension (OLE) study (NCT05299658) add to earlier reports that…

Treatment with a 30 mg dose of CNM-Au8 significantly reduced the risk of death, and the risk of death and permanent assisted ventilation, by more than 90% among people with amyotrophic lateral sclerosis (ALS), according to new top-line data from the CNM-Au8 arm of the HEALEY ALS platform…