Synaptic Pharmaceutical Corporation has initiated a Phase I clinical trial of SNEC-2 -- the company's drug candidate for treatment of depression. The compound has shown positive results in several pre-clinical studies, producing effects similar to those of serotonin reuptake inhibitors (SSRIs) such as Prozac.
However, unlike SSRIs or any drug candidates in clinical testing, SNEC-2 only targets SCT-11 - a G protein-coupled receptor (GPCR) discovered by Synaptic scientists. Management believes that this novel mechanism of action may produce higher efficacy and fewer negative side effects, compared with currently available pharmaceutical treatment alternatives for depression.
The Phase I study is designed to assess SNEC 2's safety and pharmacokinetic properties through escalating single doses administered to 40 healthy volunteers. The single-dose study will be followed by a multi-dose tolerance trial. The study is being conducted in the United States under an investigational new drug application filed with the U.S. Food & Drug Administration. The Synaptic investigative team is led by Thomas P. Blackburn, vice president, drug development and strategic alliances, whose research over 25 years with major pharmaceutical companies has led to the development of novel therapies for the treatment of depression and anxiety disorders.
Synaptic uses GPCR targets to develop compounds with improved efficacy and safety profiles. The company is also developing compounds for the treatment of obesity and diabetes.
According to the National Institute of Mental Health (NIMH), more than 18.8 million people suffer from depression in the U.S. alone, and they spend about $10 billion annually on pharmaceutical therapies. Approximately 50 percent of them are treated with SSRIs, whose side effects include sexual problems, insomnia and nausea. Tricyclic antidepressants (TCAs), administered to the majority of patients, can cause increased heart rate, weight gain and blurred vision. Monoamine oxidase inhibitors (MAOIs), another common treatment, can interact adversely with many foods, beverages and medications. Additionally, the anti-depressants available today prove ineffective for 30-35 percent of depressive patients, according to the NIMH.