MILL VALLEY, Calif., April 24, 2018 /PRNewswire/ -- The Synergy Trial, one of the largest treatment intervention clinical trials in Chronic Fatigue Syndrome (CFS) to date, tested a combination treatment consisting of a currently available stimulant drug co-administered with a micronutrient formula known to broadly support mitochondrial function. This treatment is referred to as "KPAX002".
Mylagic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a chronic, highly variable neurodegenerative disease affecting over 2 million Americans. The disease is characterized by new-onset fatigue persisting for at least 6 months that is severe enough to produce a substantial decrease in activity. ME/CFS currently has no FDA-approved treatment.
The Synergy Trial was a double-blinded, placebo-controlled study that enrolled 128 participants with moderate to severe ME/CFS. The trial was conducted at four research sites in the United States including, the ME/CFS Initiative at Stanford University, California, the Bateman Horne Center in Salt Lake City, Utah, The Sue Levine Medical Clinic in NYC, and the Dept. of Clinical Immunology, Nova Southeastern University, Ft. Lauderdale, Florida. The trial was funded by K-PAX Pharmaceuticals and the lead investigator was Stanford University Professor, Dr. Jose Montoya (see bio below).
The study's results identified that KPAX002 was most effective in subjects with more severe ME/CFS symptoms and those with both fatigue and pain; two key subgroups that responded best to the treatment. ME/CFS patients in these groups had more than double the level of improvement after treatment with KPAX002 as patients taking the placebo. KPAX002 was also found to be safe and well tolerated.
KPAX002 consists of two co-administered components – a low dosage of methylphenidate (generic Ritalin®) combined with a micronutrient formula specifically designed to support mitochondrial function. This proprietary micronutrient formula is designed to raise cellular energy production in order to improve the functioning of several bodily systems including the nervous, endocrine, and immune systems.
"We believe the results of this multicenter clinical trial support the continued development of KPAX002 as a first-line therapy for fatigue and cognitive deficits secondary to ME/CFS and other age-related mitochondrial diseases," states Jon D. Kaiser, MD, CEO of K-PAX Pharmaceuticals. He continues, "In addition to ME/CFS, there is ample research to support the assertion that Alzheimer's and Parkinson's diseases are also progressive mitochondrial diseases with the potential to respond to KPAX002. We are planning future clinical trials in these disease states as well."
Dr. Jose Montoya, the lead investigator of the Synergy Trial, is head of the ME/CFS Initiative at Stanford University. For over a decade, he has treated ME/CFS patients and conducted extensive clinical research in an effort to improve diagnosis and treatment of this debilitating illness. Dr. Montoya is available for media interviews to discuss the findings of the Synergy Trial.
K-PAX Pharmaceuticals is a clinical stage biotech company developing compounds to optimize mitochondrial function in age-related neurodegenerative diseases.
Download the study results at: http://www.ijcem.com/files/ijcem0065685.pdf
SOURCE K-PAX Pharmaceuticals