Clene Nanomedicine

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 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…

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…

Orphan drug status has been recommended in the EU for Clene Nanomedicine’s CNM-Au8, an oral therapy candidate for amyotrophic lateral sclerosis (ALS), by a committee of the European Medicines Agency (EMA). CNM-Au8 is emerging as a promising treatment for the progressive neurodegenerative condition, with…

Early use of Clene Nanomedicine’s experimental therapy CNM-Au8 reduces the risk of death by 70% in people with amyotrophic lateral sclerosis (ALS), compared with patients who experienced a nine-month delay in starting treatment. These are the findings of an updated analysis of the RESCUE-ALS Phase 2 trial…

Treatment with the experimental gold nanocrystal therapy CNM-Au8 decreased the risk of mortality by 64% among people with early amyotrophic lateral sclerosis (ALS), compared to what would be expected without treatment, according to new analyses from the RESCUE-ALS clinical trial. The findings were presented by Clene Nanomedicine,…

Treatment with Clene Nanomedicine’s experimental medicine CNM-Au8 may decrease the risk of disease progression or death in people with early amyotrophic lateral sclerosis (ALS), according to new analyses from the RESCUE-ALS clinical trial. Data also suggest that the therapy helped to prevent the loss of motor neurons in…

The HEALEY ALS platform trial, the first study to test several therapy candidates for amyotrophic lateral sclerosis (ALS) simultaneously, has completed enrollment for at least two of its first three regimens. These include Clene Nanomedicine’s CNM-Au8 (NCT04414345) and Biohaven Pharmaceuticals’ verdiperstat (NCT04436510). The recruitment status…

Clene, and its wholly owned subsidiary Clene Nanomedicine, have launched an expanded access program (EAP) in the U.S. to allow certain people with amyotrophic lateral sclerosis (ALS) to gain access to its experimental oral therapy CNM-Au8. Called CNMAu8.EAP02, the program will focus on patients who are not eligible…

Clene and its subsidiary Clene Nanomedicine are negotiating to increase their manufacturing capacity as they prepare to release findings — expected early next year — from a pivotal and enrolling Phase 3 trial of CNM-Au8 as an oral therapy aiming to slow amyotrophic lateral sclerosis (ALS) progression. Negotiations include the…