DOW JONES NEWSWIRES
Targacept Inc.'s (TRGT) treatment for manic-depressive disorder
was shown effective and safe in mid-stage clinical trials, the
company announced Tuesday, paving the way for late-stage trials and
discussions with the Food & Drug Administration approval.
The results are in contrast to some of the biopharmaceutical
company's other medicines in development, which have had setbacks,
such as a drug to treat cognitive dysfunction in schizophrenia and
an Alzheimer's drug, which it is working on with AstraZeneca PLC
(AZN).
Targacept plans to present detailed results from the trials of
its TC-5214 drug for manic-depressive order at a Society for
Neuroscience meetings scheduled in October in Chicago. It expects
late-stage trials to begin in the second quarter of next year.
The company is also in discussions with a number of
pharmaceutical companies to find a strategic partner for the
development and commercialization of TC-5214, designed as a
supplemental treatment in combination with other medications. It is
also being studied as an add-on treatment for hypertension.
The mid-stage study began a year ago at 20 sites in India and
three in the U.S. In the first eight weeks, nearly 580 subjects
received citalopram, a selective serotonin reuptake inhibitor
marketed as Celexa in the U.S. In the second phase, they continued
with Celexa along with TC-5214 or a placebo for another eight
weeks.
In the study, signs of improvement were seen after two weeks in
patients who had TC-5214 added to their dosing and increased over
the course of the study, with twice as many going into remission
than in the control group, Targacept said.
There was one severe adverse reaction, with one patient having a
seizure.
Targacept's shares closed at $3.06 on Tuesday and was at $4.56
in premarket trading. The stock is down roughly 30% in the past 10
months, but up from an all-time low of $1.40 in November. Shares
were cinged in March after an early-stage study for a pain
treatment led to Targacept saying further development wasn't
warranted.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481;
tess.stynes@dowjones.com
