According to a story from BioSpace, the biopharmaceutical company Clene Nanomedicine, Inc., has recently announced that it has completed the process of enrollment patient participants in its upcoming phase 2 clinical trial. This trial is going to be testing the company’s investigational therapy CNM-Au8 as a treatment for patients in the early stages of amyotrophic lateral sclerosis (ALS), a neurodegenerative disorder. Clene is focused on developing unique therapies for neurodegenerative illnesses. The company’s developmental focus is based on nanotechnology.
About Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis, otherwise known as Lou Gehrig’s disease, is a rare, degenerative disease that causes the death of nerve cells associated with the voluntary muscles. Little is known about the origins of the disease, with no definitive cause in about 95 percent of cases. The remaining five percent appear to inherit the disease from their parents. Symptoms initially include loss of coordination, muscle weakness and atrophy, muscle stiffness and cramping, and trouble speaking, breathing, or swallowing. These symptoms worsen steadily over time; most patients die because of respiratory complications. Treatment is mostly symptomatic, and the medication riluzole can prolong life. Life expectancy after diagnosis ranges from two to four years, but some patients can survive for substantially longer. To learn more about amyotrophic lateral sclerosis, click here.
Backed by funding from the patient group FightMND, the enrollment for the trial was actually completed ahead of schedule. This is perhaps a reflection of the dire unmet need in this disease, which is ultimately fatal after only a few years in most cases. This clinical trial will consist of the treatment period lasting 36 weeks.
CNM-Au8 is a suspension that consists of gold nanocrystals that are faceted and clean-surfaced. These particles have the potential to support intracellular biological interactions. The experimental treatment has demonstrated neuroprotective effects and remyelination activity when evaluated in preclinical models. In addition, the product showed encouraging safety characteristics in the phase 1 trial. CNM-Au8 showed potential benefit in mouse models of Parkinson’s, amyotrophic lateral sclerosis, and multiple sclerosis.
If CNM-Au8 demonstrates disease-modifying impacts in the upcoming phase 2 trial, it could signal a significant breakthrough in the treatment of amyotrophic lateral sclerosis.