Neurodegenerative disease focused clinical-stage biopharmaceutical company Cassava Sciences Inc. (SAVA:NASDAQ), today announced additional positive clinical data from a Phase 2a study of PTI-125, its investigational Alzheimer's disease drug candidate. The company's scientists presented the new data during an oral presentation today at the International Conference on Clinical Trials on Alzheimer's Disease (CTAD), in San Diego, Calif.
The late-breaking oral presentation by Cassava's Lindsay H. Burns, PhD, Vice President of Neuroscience to the CTAD conference was titled, "One-Month Oral Treatment With PTI-125, A New Drug Candidate, Reduces CSF and Plasma Biomarkers of Alzheimer's Disease." The company stated that it expects to publish a manuscript of the new clinical data in a peer-reviewed medical journal. Cassava outlined the results and noted that the new data show clinical evidence of PTI-125's mechanism of action and drug-target engagement.
The company's President & CEO Remi Barbier commented, "Today's data milestone is exciting because it provides additional support for the clinical benefits of slowing down both neurodegeneration and neuroinflammation in patients with Alzheimer's...We're eager to gain more insight on the effects of PTI-125 in Alzheimer's after we conclude, in 2020, an on-going Phase 2b study."
The company indicated in the release that "PTI-125 targets both neurodegeneration and inflammatory components of Alzheimer's disease, and as previously reported in a Phase 2a study funded by the National Institutes of Health, open-label treatment with PTI-125 significantly improved key CSF biomarkers of Alzheimer's pathology, neuroinflammation and neurodegeneration." Cassava advised that it is now evaluating PTI-125 in a confirmatory Phase 2b randomized study of approximately 60 patients with mild-to-moderate Alzheimer's disease and that Top-line results from this study are expected in 2020.
The company explains in the report that "the target of PTI-125 is an altered form of filamin A (FLNA), a scaffolding protein....Cassava's 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, which slows neurodegeneration and exerts powerful anti-neuroinflammatory effects."
Cassava Sciences further advised that it is also developing an investigational diagnostic program called PTI-125Dx to detect Alzheimer's disease with a simple blood test.
According to the company, "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."
Cassava Sciences Inc., formerly Pain Therapeutics Inc., is a clinical-stage biopharmaceutical company based in Austin, Tex. The company states that its mission is to detect and treat neurodegenerative diseases, such as Alzheimer's disease. The firm indicates that "it has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimer's disease, and owns worldwide development and commercial rights to its research programs in Alzheimer's disease, and related technology, without royalty obligations to any third-party."
Cassava Sciences began the day with a market capitalization of $31.0 million with approximately 17.22 million shares outstanding and a short interest of around 9.9%. SAVA shares opened more than 20% higher today at $2.17 (+$0.37, +20.56%) over Thursday's $1.80 closing price, and later this morning set a new 52-week intraday high price $2.55. Since the open, the stock has traded between $2.03 to $2.55 per share on very high relative volume and is currently trading at $2.12 (+$0.32, +17.78%).
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