Collaborative Medicinal Development (CMD) has enrolled the first patient in a placebo-controlled clinical trial to evaluate the safety and efficacy of CuATSM in patients with Amyotrophic Lateral Sclerosis (ALS).
The Australian biotech company plans to enroll a total of 80 patients across four clinical sites in Australia.
Amyotrophic Lateral Sclerosis is also known as Motor Neuron Disease and Lou Gehrig’s Disease. It is a progressive and fatal neurodegenerative disease and is characterized by muscle weakness due to degeneration of motor neurons.
Collaborative Medicinal Development’s clinical trial will evaluate the effects of treatment with CuATSM for a six-month period, compared to placebo on disease severity measured by Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised and on cognitive function measured by Edinburgh Cognitive and Behavioral ALS Screen. The study results can be obtained in around 18 months.
Craig Rosenfeld – CEO of Collaborative Medicinal Development said: “CuATSM is the first product candidate from CMD’s pipeline and highlights our commitment to developing innovative medicines for neurological diseases with high unmet need.”
CuATSM, which is an orally bioavailable, brain-penetrate small molecule, holds orphan drug designation from the FDA Office of Orphan Products Development for the treatment of ALS.