Jueves 27 de de Junio 2019

Psyadon Announces Positive Results from Phase 2b Clinical Study of Ecopipam for the Treatment of Tourette’s Syndrome in Children

Pharmaceuticals, Inc.
, a company
focused on treatments for neurological and psychiatric disorders,
announced today that its lead product — ecopipam — produced
significant reductions in total tic severity scores in children (7-17
years) with Tourette’s Syndrome.

The study’s primary endpoint was a statistically significant reduction
in the mean Yale Global Tic Severity Score Total Tic Score (YGTSS-TTS).
This is a well-validated and standard measure of the clinical efficacy
of drugs treating Tourette’s Syndrome. Ecopipam caused significant
reductions in the YGTSS-TTS at both two- and four weeks after initiating
treatment. Furthermore, the side effects seen in the subjects taking
ecopipam were comparable to those seen in the placebo-treated subjects,
including no clinically significant changes in standard clinical lab
tests or ECG’s, and no increases in body weights.

“Ecopipam works by blocking the dopamine D1 receptor which
differentiates it from any other drug either on the market or currently
in development. Since there hasn’t been a mechanistically new drug for
the treatment of Tourette’s in over 30 years, this could offer a better
option for people who suffer with the disease,” 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, “Too many
individuals with Tourette’s Syndrome remain symptomatic despite
treatment with available drugs, or experience side effects like weight
gain or sedation that limit their use. These results demonstrate the
efficacy of D1 antagonism, an entirely new approach that doctors and
scientists have speculated about for years. As importantly, the subjects
in the study tolerated ecopipam very well, with no weight gain,
sedation, or heart problems.”


This Phase 2b study called ‘Ecopipam Treatment of Tourette’s Syndrome in
Subjects 7-17 Years (PSY302)’, was a double-blind, randomized,
placebo-controlled crossover study conducted to assess the efficacy and
safety of ecopipam in children with Tourette’s Syndrome.

Patients were instructed to take the study medication (either ecopipam
or placebo) each evening before bedtime over a four-week treatment
period. Patients were evaluated in the clinic every other week with
telephone contacts on the alternate weeks. The primary efficacy endpoint
was the change in the Yale Global Tic Severity Score – Total Tic Score
(YGTSS-TTS), a well-validated rating scale typically used in Tourette’s
Syndrome trials. The study was fully enrolled at 40 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.


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.


Psyadon Pharmaceuticals, Inc.
Dr. R.E. Chipkin, 301-919-2020
Seneca Meadows Parkway
Germantown, MD 20876