Adamas Pharmaceuticals recently reported positive results from its Phase 2 proof-of-concept clinical trial evaluating ADS-5102 (amantadine HCl), an extended-release version of amantadine, in multiple sclerosis (MS) patients with difficulties in walking.
The trial (NCT02471222), a double-blind, placebo-controlled and two-arm parallel group study, evaluated ADS-5102 given once daily at 340 mg, at bedtime, for four weeks to the 60 MS patients enrolled.
Primary outcome measures included the safety of ADS-5102, as assessed by adverse events, safety-related drug discontinuation, vital signs, and laboratory tests. Secondary outcomes looked at measures of walking ability, including the timed 25-foot walk (T25FW), Timed Up and Go, 2 Minute Walk test, and MS Walking Scale-12. Other outcomes assessed disease symptoms, such as Fatigue Scale for Motor and Cognitive Functions, the Beck’s Depression Inventory-2, and the Brief International Cognitive Assessment for MS.
Findings indicated that ADS-5102 is well-tolerated in patients with MS, and has a positive impact on walking speed, with a nearly 15 percent placebo-adjusted improvement seen in the T25FW.
But even more interesting is the approach that Adamas is taking in modifying existing old drugs to make them work better for different populations.
If they are specializing on treatments for chronic diseases of the central nervous system, wonder how long it will be before they stumble upon something helpful for MECFS too?
Adamas specializes in modifying the pharmacokinetic profiles of approved drugs to create new treatments for chronic diseases of the central nervous system, like ADS-5102. “We believe these novel data showing a benefit of ADS-5102 on walking speed in MS patients … further validate the strength of Adamas’ ‘shape matters’ discovery and development platform,” Dr. Went said. “The notion of shape incorporates aspects like timing, the profile and drug level, and how they can be modified to improve the way medicines behave in the body.”