Full Press Release Details
VistaGen Therapeutics Expands European Patent Protection for AV-101
for Treatment of Depression and Dyskinesia associated with Levodopa
Therapy for Parkinson's Disease
SOUTH SAN FRANCISCO, Calif., October 28, 2019 VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
central nervous system (CNS) diseases and disorders with high unmet
need, today announced that the European Patent Office (EPO) has
granted the Company a second patent for therapeutic uses of AV-101,
its oral NMDA (N-methyl-D-aspartate) receptor glycine site
antagonist. The new patent expands the set of claims relating to
treatment of depression and dyskinesia (involuntary or diminished
voluntary muscle movements) associated with levodopa therapy for
Parkinson's disease. The patent will be in effect until at
(4-Cl-KYN) belongs to a new generation of investigational medicines
in neuropsychiatry and neurology known as NMDA receptor modulators.
The NMDA receptor is a pivotal receptor in the brain and its
abnormal function is associated with numerous CNS diseases and
disorders. AV-101 is in
Phase 2 clinical development in the United States, initially for
treatment of Major Depressive Disorder (MDD). Among
VistaGen's key objectives for AV-101 in MDD is to replace atypical
antipsychotics in the current MDD drug treatment paradigm and to
redefine the standard of care for individuals who are unable to
reduce symptoms of depression with their current oral
antidepressant alone. VistaGen recently completed patient dosing in
the ELEVATE study, its U.S. multi-center, randomized, double-blind,
placebo-controlled Phase 2 clinical study to evaluate the efficacy
and safety of adjunctive use of AV-101 in adult MDD patients who
have an inadequate response to their current oral antidepressant
therapy. The Company remains on track to report top line results of
the ELEVATE study before the end of 2019.
previously announced positive preclinical studies of the effects of
AV-101 in a widely-used non-human primate model for reproducing
motor complications of Parkinson's disease (PD) and dyskinesia
observed in PD patients treated with levodopa, AV-101 significantly
(p = 0.01) reduced levodopa-induced dyskinesia without affecting
the timing, extent, or duration of the antiparkinsonian benefits of
levodopa. AV-101's therapeutic effects were similar to those
generally observed with amantadine therapy, but AV-101 did not
cause adverse effects experienced with amantadine.
About Major Depressive Disorder (MDD)
a serious neurobiologically-based mood disorder affecting nearly
300 million globally and is the leading cause of disability
worldwide, according to the World Health Organization. Individuals
diagnosed with MDD exhibit depressive symptoms, such as a depressed
mood or a loss of interest or pleasure in daily activities, for
more than a two-week period, as well as impaired social,
occupational, educational or other important functioning which has
a negative impact on their quality of life.
About Parkinson's Disease (PD)
the second most common neurodegenerative disease worldwide,
affecting approximately one million people in the U.S. and ten
million people worldwide, according to the Parkinson's Foundation.
Although there is no "one-size-fits-all" description of PD, PD is a
complex neurodegenerative disorder that occurs when brain cells
that make dopamine, a chemical that coordinates movement, stop
working or die, resulting in progressive deterioration of voluntary
motor control. Classic PD motor symptoms include muscular rigidity,
resting tremor, and postural and gait impairment. Typically, PD
patients present with a combination of motor and non-motor
symptoms. Non-motor symptoms may include cognitive impairment,
sleep disorders, pain and fatigue. There is currently no medication
to slow, delay, stop or cure PD, and currently available treatments
are symptomatic. Treatment of motor symptoms of PD with oral
levodopa, introduced about 50 years ago, remains the gold standard
About Levodopa-Induced Dyskinesia (LID)
a disorder that affects people with PD who are treated with the
current gold standard of care, oral levodopa, for an extended
period of time. Oral levodopa remains the most effective therapy
for motor symptoms of PD. However, after continuous long-term use
(longer than five years), many PD patients experience LID. Although
clinical manifestations of LID are diverse, LID is commonly
associated with abnormal involuntary movements, including chorea
and dystonia. These motor complications tend to become more severe
as PD progresses and as the duration of levodopa treatment is
extended, until the impact of LID may compromise the advantage of
treatment with levodopa. PD treatment with levodopa is routinely
delayed due to concerns over LID. Once LID develops,
levodopa-treated PD patients may be faced with a choice between
immobility due to untreated (and uncontrolled) PD, or mobility with
(4-Cl-KYN) belongs to a new generation of investigational medicines
in neuropsychiatry and neurology known as NMDA
(N-methyl-D-aspartate) receptor modulators. The NMDA receptor is a
pivotal receptor in the brain and abnormal NMDA function is
associated with numerous CNS diseases and disorders. AV-101 is an
oral prodrug of 7-Cl-KYNA, a potent and selective full antagonist
of the glycine co-agonist site of the NMDA receptor. With its
exceptional safety profile in all studies to date, AV-101 has
potential to be a new at-home, non-sedating treatment for multiple
large market CNS indications where current treatments are
inadequate to meet high unmet patient needs. VistaGen is currently
focused on potential development of AV-101 for MDD, neuropathic
pain, suicidal ideation and dyskinesia associated with levodopa
treatment for PD. The FDA has granted Fast Track designation for
development of AV-101 as both a potential adjunctive treatment
for MDD and as a non-opioid treatment
for neuropathic pain.
Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for CNS diseases and disorders