AUSTIN, Texas, Oct. 24, 2019 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biopharmaceutical company focused on Alzheimer’s disease, today announced that clinical results of its Phase 2a study of PTI-125 have been selected as a late-breaking oral presentation by the 12thInternational Conference on Clinical Trials on Alzheimer’s Disease (CTAD). CTAD is a prestigious annual conference focused on Alzheimer’s research and development and takes place this year in San Diego, CA, on December 4-7th, 2019.
PTI-125 is Cassava Sciences’ lead drug candidate for Alzheimer’s disease. The drug targets both neurodegeneration and inflammatory components of Alzheimer’s disease. In a first-in-patient, Phase 2a study funded by the National Institutes of Health (NIH), treatment with PTI-125 for 28 days reduced biomarkers of Alzheimer’s pathology, neuroinflammation and neurodegeneration, consistent with years of basic research and pre-clinical data.
Details of CTAD Presentation:
Title: “One-Month Oral Treatment With PTI-125, A New Drug Candidate, Reduces CSF and Plasma Biomarkers of Alzheimer’s Disease.”
||Late-Breaking Oral Presentation (LB6)
||Lindsay H. Burns, PhD, co-discoverer of PTI-125
||Thursday, December 5th at 8:15 a.m. PT
||Hilton Bayfront, San Diego
Cassava Sciences’ CTAD presentation will be available on its website (CassavaSciences.com) on the day of the presentation in the Investors page.
As a result of positive clinical results from its Phase 2a study of PTI-125 in Alzheimer’s disease, Cassava Sciences recently initiated a Phase 2b study. Phase 2b is designed to evaluate safety, tolerability and drug effects of PTI-125 on Alzheimer’s disease. This blinded, randomized, placebo-controlled, oral dose study will enroll approximately 60 patients with mild-to-moderate Alzheimer’s disease. Patients will be dosed with PTI-125 100 mg, 50 mg or matching placebo, twice daily for 28 continuous days. The primary endpoint is improvement in biomarkers of Alzheimer’s disease from baseline to Day 28. The study is supported by a clinical research grant award from NIH.
About PTI-125 and Cassava Sciences’ Scientific Approach
The target of PTI-125 is an altered form of filamin A (FLNA), a scaffolding protein. Published studies have shown that altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. Cassava Sciences’ lead drug candidate, PTI-125, is a small molecule that restores the normal shape and function of FLNA in the brain. This action improves the function of certain receptors in the brain and exerts powerful anti-neuroinflammatory effects.
Cassava Sciences is also developing an investigational diagnostic to detect Alzheimer’s disease with a simple blood test. This program, called PTI-125Dx, also receives significant scientific and financial support from NIH.
The underlying science for Cassava Sciences’ programs in neurodegeneration is published in several prestigious peer-reviewed technical journals, including Journal of Neuroscience, Neurobiology of Aging, and Journal of Biological Chemistry. As previously announced, NIH has awarded Cassava Sciences two research grants following an in-depth, confidential review of its science and technology. These two grant awards represent up to $6.7 million of non-dilutive financing.
About Alzheimer's Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. In the U.S. alone, approximately 5.8 million people are currently living with Alzheimer’s disease, and approximately 487,000 people age 65 or older will develop Alzheimer’s in 2019.1 The number of people living with Alzheimer’s disease is expected to grow dramatically in the years ahead, which may also result in a growing social and economic burden.2
About Cassava Sciences, Inc.
The mission of Cassava Sciences is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Over the past ten years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimer’s disease. Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technology, without royalty obligations to any third-party.
Cautionary 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). Cassava Sciences 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 status of Phase 2 clinical studies; the interpretation of clinical results, including potential health benefits, if any, in improvements in levels of biomarkers; and potential benefits, if any, of the Company’s product candidates for Alzheimer’s disease. The Company cautions that forward-looking statements are inherently uncertain. Such statements are based on 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 specificity, safety, efficacy or potential health benefits of our product candidates and including those described in the section entitled “Risk Factors” in Cassava’s Annual Report on Form 10-K for the year ended December 31, 2018 and future reports to be filed with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov.
1, 2 Source: Alzheimer’s Association. 2019 Alzheimer’s Disease Facts and Figures. Available online at: https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf
Source: Cassava Sciences, Inc.