GERMANTOWN, Md.–(BUSINESS WIRE)–Psyadon
Pharmaceuticals, Inc., a pharmaceutical company focused on
treatments for neurology and psychiatry, announced today that the
independent Drug Safety Monitoring Board (DSMB) overseeing its Phase 2b
study of ecopipam in children (7-17 years) with Tourette’s Syndrome has
recommend the study’s continuation based on its scheduled interim review
of the data.
The protocol specified that when half the anticipated subjects had
completed, the DSMB would meet to review the data and determine if the
study should proceed as planned. The DSMB had several possible options
including (1) stopping the study if there was no possibility of success;
(2) stopping the study if there were sufficiently serious side effects
which would outweigh any clinical benefit; (3) recommend changes to the
protocol to increase the probability of a definitive outcome (e.g.,
increase the number of subjects to insure statistically meaningful
results could be obtained); or (4) allow the study to continue without
change. The DSMB recommend that the study continue and include four
additional participants, for a total enrollment of 34 subjects.
“This positive interim analysis is an important milestone in the
development of ecopipam. While no conclusion about the drug’s activity
can be inferred from the DSMB’s decision, we are encouraged by their
findings and highly motivated to complete this study,” said Richard
Chipkin, Ph.D., President and Chief Executive Officer of Psyadon.
Donald Gilbert, M.D., the study’s Principal Investigator and Professor
and Director of the Movement Disorder and Tourette Syndrome clinics at
Cincinnati Children’s Hospital Medical Center said, “The decision by the
DSMB fits with what we are observing in the trial. Given the unique
mechanism of action of this medication and the need for better Tourette
treatments, the investigators are working to complete enrollment as soon
ABOUT THE STUDY
This Phase 2b study called ‘Ecopipam Treatment of Tourette’s Syndrome in
Subjects 7-17 Years (PSY302)’, is a double-blind, randomized,
placebo-controlled crossover study conducted to assess the efficacy and
safety of ecopipam in children with Tourette’s Syndrome.
Patients are instructed to take the study medication (either ecopipam or
placebo) each evening before bedtime over a 4-week treatment period.
Patients are evaluated in the clinic every other week with telephone
contacts on the alternate weeks. The primary efficacy endpoint is the
change in the Yale Global Tic Severity Score (YGTSS), a well-validated
rating scale typically used in Tourette’s Syndrome trials. The study was
originally designed to enroll 30 patients, and the pre-scheduled interim
analysis was performed upon completion of 15 subjects. Based on the
DSMB’s recommendation, the new enrollment goal is 34 subjects.
Ecopipam is a first-in-class drug that selectively blocks the actions of
the neurotransmitter dopamine at its receptor. Dopamine receptors can be
broadly classified into two families based on their structures: “D1
receptors” and “D2 receptors.” Ecopipam blocks dopamine only at D1
receptors. There is evidence that overactive dopamine systems in the
brain are responsible for the symptoms of Tourette’s Syndrome, and that
D1 receptors play a pivotal role. In contrast, all currently marketed
dopamine antagonists for the treatment of Tourette’s act at D2 receptors.
ABOUT PSYADON PHARMACEUTICALS
Psyadon Pharmaceuticals is dedicated to the discovery and development of
new treatments for serious neurological and psychiatric diseases.
Ecopipam, our first development candidate, selectively blocks the
actions of the neurotransmitter dopamine at the D1 receptor-family in
the brain. This first-in-class compound has the potential to
successfully help people who previously had no other therapeutic options.
For more information please visit www.psyadonrx.com.