- Study to evaluate safety and tolerability of
extended-release fixed dose combination ML-007/PAC with
precision-matched release kinetics in advance of planned Phase 2
clinical trials
- ML-007/PAC dosing regimens to be assessed in healthy
non-elderly and elderly adults
SAN
FRANCISCO and BOSTON, March 28,
2024 /PRNewswire/ -- MapLight Therapeutics, a
clinical-stage biopharmaceutical company working to develop
targeted novel therapeutics to improve the lives of patients
suffering from debilitating CNS disorders, today announced
initiation of a Phase 1 clinical trial evaluating ML-007/PAC,
MapLight's extended-release fixed-dose combination formulation of
the novel, investigational muscarinic agonist ML-007 and a
precision-matched peripherally active anticholinergic (PAC). This
trial builds upon findings from three prior Phase 1 clinical trials
evaluating safety and tolerability of ML-007 co-administered with
the PAC.
"We are pleased with the continued progress
of our ML-007 clinical development program."
This four-cohort trial will evaluate the safety, tolerability
and pharmacokinetics (PK) of several dose strengths of ML-007/PAC
in healthy non-elderly and elderly adults.
"We are pleased with the continued progress of our ML-007
clinical development program," stated Christopher Kroeger, M.D., MBA, Chief Executive
Officer and Founder. "We have already evaluated the safety and
tolerability profile of ML-007 dosed alone or with the PAC in three
clinical trials and observed favorable tolerability results in
adults, including in elderly subjects. Data from this fourth Phase
1 trial will inform the ML-007/PAC dosing regimen to bring forward
into our planned Phase 2 trials in schizophrenia and Alzheimer's
disease psychosis. We look forward to initiating our first Phase 2
trial of ML-007/PAC in schizophrenia later this year."
"There still remains a profound level of unmet need in the
treatment of schizophrenia with about 60% of patients having only a
partial response or no response to treatment," said John Kane M.D., Donald
and Barbara Zucker School of Medicine at Hofstra/Northwell. "The clinical trial evidence for
muscarinic receptor agents has been very encouraging, and I believe
this new class of agents has the potential to improve the overall
treatment of schizophrenia."
About ML-007
ML-007 is an
investigational, CNS-penetrant muscarinic
receptor agonist designed to target
M1 and
M4 muscarinic receptor
subtypes with no direct activity on dopamine receptors. Deficits in
M1 receptors are linked to
schizophrenia, and M1 receptors
directly regulate neural circuits known to be important in both
psychosis and cognition. M4 receptors
regulate a complementary neural circuit known to be important in
psychosis.
About ML-007/PAC
ML-007/PAC, also referred to as
ML-007C-MA, is an extended-release fixed-dose combination of the
investigational, M1/M4 muscarinic agonist,
ML-007, co-formulated with a peripherally acting anticholinergic
(PAC). ML-007/PAC was specifically designed to unlock the full
potential of ML-007 by pairing it with a precision-matched
anticholinergic and to optimize pharmacokinetic synchronization of
its agonist and antagonist components, without sacrificing
activation of both M1 and M4 receptors.
About Schizophrenia
Schizophrenia is a serious,
debilitating mental illness characterized by disturbances in
perception, thinking, emotional reaction, and behavior.
Schizophrenia can cause people to interpret reality abnormally and
includes a combination of positive, negative, and cognitive
symptoms. Approximately 60% of people with schizophrenia have no
response or only a partial response to the available standard of
care treatments, leaving a substantial portion of the population
with urgent unmet needs.
About Alzheimer's Disease
Psychosis
Approximately 40% of people in the United States who are diagnosed with
Alzheimer's disease (AD) also experience symptoms of psychosis.
These symptoms are associated with a worsened prognosis and are
predictive of earlier progression to nursing home care, severe
dementia and death. Despite the severity of the condition, there
are no therapies approved by the FDA for the treatment of AD
psychosis.
About MapLight Therapeutics
MapLight is a
clinical-stage biopharmaceutical company focused on improving the
lives of patients suffering from debilitating central nervous
system, or CNS, disorders. MapLight was founded by
globally-recognized leaders in psychiatry and neuroscience research
to address the lack of circuit-specific pharmacotherapies available
for patients. MapLight's discovery platform holds the potential to
fill this void by identifying neural circuits causally linked to
disease and targeting those circuits for therapeutic modulation.
Learn more at www.maplightrx.com.
Media Contact for MapLight Therapeutics
Charmaine Lykins, Chief Commercial Officer,
clykins@maplightrx.com
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SOURCE MapLight Therapeutics, Inc.