February 24, 2014
Synchroneuron Inc., a biopharmaceutical company engaged in developing new therapies to treat tardive dyskinesia (TD) and other neuropsychiatric disorders, today announced that the first patient has been dosed in a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety and pharmacokinetic behavior of orally-administered SNC-102, a new formulation of acamprosate calcium.
“There is a significant unmet medical need among patients who suffer from tardive dyskinesia, and SNC-102 has the potential to bring these patients much needed relief from the often debilitating involuntary movements that characterize this disease”
Synchroneuron expects to enroll 90 patients across 12 clinical sites. The Phase 2 study will evaluate the clinical efficacy of SNC-102 tablets as measured by the Abnormal Involuntary Movement Scale (AIMS), the standard rating scale for measuring severity of involuntary movements in TD. Using this scale, the study will evaluate the effectiveness of SNC-102 once daily (QD) or twice daily (BID) versus placebo over a four week treatment period. The study will also characterize the pharmacokinetic profile in TD patients and its relationship to the clinical effects of the drug.
“Synchroneuron is committed to the development of what could be the first approved drug therapy for tardive dyskinesia, offering relief to patients who suffer the disabling and stigmatizing effects of TD,” said William Kerns, DVM, Chief Executive Officer of Synchroneuron Inc.
SNC-102 is a unique formulation of acamprosate calcium, an FDA-approved drug for treating alcohol dependence. The use of acamprosate calcium in the treatment of TD was pioneered by Synchroneuron co-founder and inventor, Barry Fogel, MD. Dr. Fogel is a neuropsychiatrist and behavioral neurologist at the Brigham and Women’s Hospital and Clinical Professor of Psychiatry at Harvard Medical School. SNC-102 was developed by Synchroneuron to improve the pharmacokinetic properties of acamprosate. Synchroneuron’s Phase 1 studies have shown that SNC-102 can produce sustained plasma levels of acamprosate that are anticipated to be efficacious for treating TD and potentially other neuropsychiatric disorders.
“There is a significant unmet medical need among patients who suffer from tardive dyskinesia, and SNC-102 has the potential to bring these patients much needed relief from the often debilitating involuntary movements that characterize this disease,” saidGary Remington, MD, Professor of Psychiatry at the University of Toronto. Dr. Remington, an internationally-recognized authority on TD, is an advisor to Synchroneuron.
The participating clinical sites include five academic centers of excellence in neurology and psychiatry. The sites are:
Atlanta Center for Medical Research, Atlanta, GA
Baylor College of Medicine, Houston, TX
Claghorn-Lesem Research Clinic, Houston, TX
Collaborative Neuroscience Network, Garden Grove, CA
FutureSearch Trials, Austin, TX
InSite Clinical Research, DeSoto, TX
Northwestern University, Chicago, IL
Pacific Research Partners, Oakland, CA
Rush University Medical Center, Chicago, IL
Synergy Research, National City, CA
UCLA-Greater Los Angeles VA, Los Angeles, CA
University of South Florida, Tampa, FL
For patients and physicians interested in enrollment information, please visit http://www.clinicaltrials.gov/ct2/show/NCT02064010?term=SNC-102&rank=1.
Read the full press release here.