Pain Therapeutics Announces Successful Phase I Clinical Study for PTI-125
October 24 2017 - 7:30AM
Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today the
completion of a Phase I clinical study for PTI-125, a new
experimental drug therapy to treat Alzheimer’s Disease. This
study investigated for the first time the safety, dosing and
pharmacokinetic profile of PTI-125 in healthy human volunteers.
Summary of Key Findings
- PTI-125 was safe and well-tolerated at all doses studied
- PTI-125 demonstrated favorable pharmacokinetics for further
drug development
"The clinical data are encouraging,” said Remi
Barbier, President & CEO of Pain Therapeutics. “Given the
absence of dose-limiting effects in healthy adults, an excellent
non-clinical safety database, a strong scientific rationale, and
multiple peer-reviewed publications and research grant awards, we
are eager to move this drug program to the next level of
development.”
About the Phase I
StudyPTI-125 was evaluated in 24 healthy human volunteers
in a single-site in the U.S. for safety, tolerability and
pharmacokinetics. Study subjects were administered a single
oral dose of 50, 100 or 200 mg of PTI-125. The drug was
well-tolerated in all subjects. Importantly, PTI-125 showed
no treatment-related adverse effects and no dose-limiting safety
findings. Pharmacokinetic measurements showed PTI-125, a
small molecule, was rapidly absorbed. Dose-proportionality
outcomes were observed over the entire dose range of 50 to 200
mg. Company scientists plan to present full results of this
study at the 10th Annual International Conference on Clinical
Trials on Alzheimer’s Disease (CTAD), in Boston, MA, on November
1-4th.
Pain Therapeutics conducted this study with
support from a $1.7 million research grant award from the National
Institute on Aging, part of the National Institutes of Health.
About Alzheimer's Disease and
PTI-125Alzheimer's disease (AD) is a progressive brain
disorder that slowly destroys memory and thinking skills, and
eventually the ability to carry out the simplest tasks.
Damage to the brain starts a decade or more before problems appear.
During this early stage of disease, people seem to be
symptom-free, but toxic changes are taking place in the
brain. Eventually, brain damage becomes widespread and
affected people are often unable to care for themselves.
Currently, Alzheimer’s cannot be detected until symptoms
appear. Over five million Americans live with Alzheimer’s, a
number that will increase significantly in the coming years.
PTI-125 is a small molecule drug candidate that
was designed in-house and characterized by outside
collaborators. PTI-125 has been shown to significantly
improve AD neuropathologies in mouse models of the disease and in
post-mortem brain tissue from AD patients, including receptor
dysfunctions, neuroinflammation, tau hyperphosphorylation, insulin
resistance and plaques and tangles that are hallmarks of
AD.
PTI-125 works by binding to filamin A (FLNA), a
protein critical to beta amyloid’s toxicity. Beta amyloid
exerts multiple toxic effects, eventually causing the plaques and
tangles found in the brains of people with Alzheimer’s. By
binding to FLNA, PTI-125 prevents and even reverses amyloid-related
Alzheimer’s damage. Building on this science, we also have
under development a blood-based diagnostic for AD. Support
for our diagnostic program is being funded by a $1.8 million
research grant award from the National Institutes of Health.
The underlying science for PTI-125 has been
published in Journal of Neuroscience, Neurobiology of Aging,
Journal of Biological Chemistry, PLOS-One and other peer-reviewed
scientific journals.
Pain Therapeutics owns all worldwide development
and commercial rights to PTI-125 and related technology, without
royalty or other obligations to third-parties.
About Pain
Therapeutics, Inc.Pain Therapeutics, Inc. is a
clinical-stage biopharmaceutical company that develops novel
drugs. The FDA has not yet established the safety or efficacy
of any of our drug candidates. For more information, please
visit www.paintrials.com.
Note Regarding Forward-Looking
Statements: This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the "Act"). Pain Therapeutics disclaims any
intent or obligation to update these forward-looking statements,
and claims the protection of the Safe Harbor for forward-looking
statements contained in the Act. Examples of such statements
include, but are not limited to, statements regarding the safety or
effectiveness of PTI-125 and the Company’s plan to develop PTI-125
for Alzheimer’s Disease. Such statements are based on
management's current expectations, but actual results may differ
materially due to various factors. Such statements involve
risks and uncertainties, including, but not limited to, those risks
and uncertainties relating to the ability to demonstrate the
safety, efficacy or potential health benefits of PTI-125. For
further information regarding these and other risks related to our
business, investors should consult our filings with the U.S.
Securities and Exchange Commission.
For More Information Contact:Ruth
ArayaPain Therapeutics, Inc.IR@paintrials.com(512) 501-2485
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