US-based biopharmaceutical firm Synchroneuron has dosed the first patient in a multi-centre, randomised, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy, safety and pharmacokinetic behaviour of orally administered SNC-102, a new formulation of acamprosate calcium, for the treatment of tardive dyskinesia (TD).
Around 90 patients will be enrolled in the trial, which will be carried out at 12 clinical sites to 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 AIMS, the trial will assess the effectiveness of SNC-102 once daily (QD) or twice-daily (BID) versus placebo over a four week treatment period.
The trial will also characterise the pharmacokinetic profile in TD patients and its relationship to the clinical effects of the drug.
Synchroneuron chief executive officer William Kerns said: "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 stigmatising effects of TD."
Developed by Synchroneuron, SNC-102 is a formulation of acamprosate calcium, an FDA-approved drug for treating alcohol dependence, designed to improve the pharmacokinetic properties of acamprosate.
The company's Phase I trials have demonstrated that SNC-102 can produce sustained plasma levels of acamprosate that are expected to be efficacious for treating TD and potentially other neuropsychiatric disorders.
University of Toronto professor of Psychiatry Gary Remington said: "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 characterise this disease."
The company said that participating sites in the trial include five academic centres of excellence in neurology and psychiatry.
The clinical sites include Atlanta Center for Medical Research; Baylor College of Medicine; Claghorn-Lesem Research Clinic; Northwestern University; Pacific Research Partners; Rush University Medical Center; Synergy Research; UCLA-Greater Los Angeles VA, and University of South Florida.