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Pain Therapeutics Announces Initiation of a Phase II Study in Alzheimer’s Disease

AUSTIN, Texas, Dec. 06, 2018 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (PTIE), a biopharmaceutical company, announced today the initiation of a Phase II study to evaluate PTI-125 as a potential first line treatment in patients with Alzheimer’s disease. This clinical study is supported by a research grant award from the National Institute on Aging (NIA), the primary Federal agency supporting new research in Alzheimer’s disease.

“There is a profound and timely need to develop new drugs for Alzheimer’s,” said Remi Barbier, President & CEO. “We are excited about the clinical potential of PTI-125, as this drug candidate represents a promising new approach for the treatment and prevention of Alzheimer’s.”

This Phase IIa study is designed to evaluate safety, tolerability, pharmacokinetics and biomarkers in 12 patients with mild-to-moderate Alzheimer’s treated with PTI-125 twice-daily for 1 month. In mid-2019, the Company expects to conduct a Phase IIb study in 36 patients with Alzheimer’s treated with PTI-125 for 3 months. Collectively, the Phase IIa and Phase IIb studies are intended to demonstrate target engagement, and possibly prepare PTI-125 for a pivotal efficacy program.

About PTI-125
PTI-125 is the Company’s proprietary drug candidate that targets an altered form of Filamin A. Publications show that altered Filamin A is responsible for multiple pathologies observed in the Alzheimer’s brain. PTI-125 restores altered Filamin A back to its proper conformation. This results in dramatically improved brain health in animal models, including reduced amyloid deposits, reduced neuroinflammation, improved insulin resistance in the brain and improved learning and memory. Importantly, PTI-125 is not dependent on clearing amyloid from the brain.

The science and technology for PTI-125 is published in prestigious peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, and Neuroimmunology and Neuroinflammation, and has been awarded multiple competitive research grants from the NIA.

The underlying science for PTI-125 also supports the development of a biomarker/diagnostic to detect Alzheimer’s disease with a simple blood test, possibly years before any symptoms appear. 

About Alzheimer's Disease
Alzheimer’s Disease (AD) is a progressive brain disorder that destroys memory and thinking skills. Eventually, a person with AD may be unable to carry out even simple tasks. Currently, there are no drug therapies to halt AD or slow its progression. As baby boomers age, the number of people with AD is expected to soar in the coming years, both in the U.S. and abroad.

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 timing of clinical studies; and the potential benefits of the Company’s program in 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 our financial and operational ability to carry out development activities around Alzheimer’s disease. 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:
Eric Schoen
Chief Financial Officer
Pain Therapeutics, Inc.
(512) 501-2450