Adamas Pharmaceuticals, Inc., a pharmaceutical company focused on chronic conditions that affect the central nervous system, recently announced results from two non-clinical studies showing that the company’s product candidate ADS-5102 can be potentially applied as a treatment for multiple sclerosis (MS) symptoms.
MS is a chronic, progressive neurodegenerative autoimmune disorder that results from the attack to the central nervous system (brain, spinal cord and optical nerves) by the body’s own immune system, causing inflammation and damage to the myelin layer (demyelination) that covers and protects nerve fibers. Myelin loss leads to impairment in signal transmission along the nerve fibers, affecting motor function and causing irreversible neurological disability and paralysis. In 2013, it was estimated that among the American MS patients, 76% suffered from walking impairment and 89% from fatigue.
ADS-5102 (amantadine HCl), is an extended release version of amantadine. Non-clinical studies using in vitro and in vivo models of MS have been developed to assess the efficacy of the drug in treating MS-related symptoms, such as walking impairment.
According to Adamas, one of these studies revealed that chronic administration of ADS-5102 at a dose matching the human plasma levels of the drug induced an improvement in walking. The second non-clinical study offered insights into the possible mechanism of action of amantadine in MS, suggesting that the drug blocks neuronal potassium channel activity, which may in turn lead to enhanced electrical impulses across demyelinated regions of neurons.
The combined results suggest that ADS-5102 may represent a potential valuable treatment strategy for major MS symptoms, including walking impairment.
“We are encouraged by these nonclinical data and what they mean with respect to the potential of ADS-5102, our extended release version of amantadine, in addressing MS-related symptoms, including walking impairment,” said the Senior Vice President of Product Development at Adamas Pharmaceuticals, Inc., Dr. Natalie McClure in a press release. “With the improved pharmacokinetic profile of ADS-5102, we can potentially administer higher therapeutic doses than is common with immediate release amantadine.”
Adamas announced in June 2015 the start of a Phase 2 clinical trial on ADS-5102 (340 mg, once daily at bedtime) assessing its efficacy, safety and tolerability in the treatment of major MS-related symptoms in patients with walking impairment. The company expects to enroll approximately 60 patients in the trial. The team will assess participants in terms of fatigue and walking capacity. The duration of the trial is four weeks, and results are expected in 2016.