Synaptic Pharmaceutical Initiates Phase-I Clinical Trial For Antidepressant SNEC-2(R)
PARAMUS, N.J., Feb. 5 /PRNewswire-FirstCall/ -- Synaptic Pharmaceutical Corporation (Nasdaq: SNAP - news) announced today that it 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.
``Most widely used anti-depressants today seem to regard depression as an undifferentiated disorder, amenable to a single type of treatment,'' said Kathleen P. Mullinix, Ph.D., Synaptic's president and chief executive officer. ``They only become effective weeks after the initial administration. The state of the art in the treatment of depression has created a need for a targeted, tailored intervention without the forbidding side effects of commercially available anti-depressants. This is the need that SNEC-2 is designed to address. The compound creates a targeted cellular impact; it pinpoints a particular neuroreceptor and circumvents the receptors that may lead to unwanted side effects.''
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.
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, Ph.D., 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. ``SNEC-2 is only one example of how our technology platform is advancing the study and treatment of depression. In addition to SCT-11, we have discovered two other GPCRs - SCT-20 and SCT-24 that also may be targets for additional depression therapies. Beyond depression, our GPCR-based compounds have already shown promise in the treatment of migraine and incontinence, as well,'' said Dr. Mullinix. The company is also developing compounds for the treatment of obesity and diabetes.
In 2000, Synaptic adopted a new strategy, under which it intends to use its own resources to advance drug candidates through Phase II trials, before partnering with a major pharmaceutical company. In 2001, Synaptic raised $41 million in private financing to support its internal research and development efforts. ``We are executing on our strategy, starting with SNEC-2. Our cash position is strong and will enable us to proceed on our own until the time is right for us to seek a partnership for commercialization.'' commented Dr. Mullinix.
Synaptic Pharmaceutical will hold a conference call on Tuesday, February 5, 2002 at 11:00 a.m. ET to discuss the progress of the depression program. If you wish to participate, please call 1-800-395-0708 at least 10 minutes prior to conference time. The conference will also be webcast and can be accessed through the company's website at synapticcorp.com. |
