Clinical-stage biotechnology company Cassava Sciences Inc. (SAVA:NASDAQ), which focuses on neurodegenerative diseases including Alzheimer's disease, today announced results of an "interim analysis from an open-label study of simufilam, its lead drug candidate for the treatment of Alzheimer's disease." The firm indicated that after six months of treatment with simufilam, patients' cognition and behavior scores both improved without any reportable safety issues or serious drug-related adverse events.
Cassava Sciences advised that in its ongoing clinical study, which is funded by the National Institutes of Health, "six months of simufilam treatment improved cognition scores by 1.6 points on ADAS-Cog11, a 10% mean improvement from baseline to month 6 and that in these same patients, simufilam also improved dementia-related behavior, such as anxiety, delusions and agitation, by 1.3 points on the Neuropsychiatric Inventory, a 29% mean improvement from baseline to month 6."
The company's President & CEO Remi Barbier remarked, "We could not be more pleased with these interim results...We would have been satisfied to show simufilam stabilizes cognition in patients over 6 months. An improvement in cognition and behavior tells us this drug candidate has potential to provide lasting treatment effects for people living with Alzheimer's disease. It's an exciting development."
Cassava Sciences' Chief Medical Officer Nadav Friedmann, Ph.D., M.D., added, "Today's data once again suggests simufilam could be a transformative, novel therapeutic...It appears the drug's unique mechanism of action has potential to provide a treatment benefit following 6 months of dosing."
Cassava Sciences' explained that the interim analysis data was gathered from its current, one-year multi-center study of 100 patients diagnosed with mild-to-moderate Alzheimer's disease. The trial is aiming to evaluate long-term safety and tolerability in participants dosed with twice daily 100 mg simufilam. The firm noted that the trial commenced in March 2020 and presently is about 80% enrolled. The company stated that today's planned interim analysis pertains to the first 50 patients enrolled in the study that reached the six-month midpoint of treatment with simufilam.
The company believes that the data presented today along with prior clinical study results offers a strong basis and support for advancing simufilam into a Phase 3 clinical trial for the treatment of Alzheimer's disease. The firm noted that it is on track to commence a planned Phase 3 trial in H2/21.
The firm stated that it recently concluded a successful end-of-phase 2 (EOP2) discussion with the U.S. Food and Drug Administration (FDA) regarding its simufilam drug development program. The company said it expected to report the findings from the meeting in Q1/21 after the meeting minutes are officially prepared and available.
Cassava Sciences noted that it expects to enroll 150 Alzheimer's patients in the upcoming Phase 3 simufilam trial. Previously, plans called for enrollment of 100 patients but was increased due to increased requests by Alzheimer's patients and their caregivers.
The company noted that "Alzheimer's disease is a progressive brain disorder that destroys memory and thinking skills and that presently, there are no drug therapies to halt Alzheimer's disease or to reverse its course." The firm reported that there are approximately 5.8 million people in the U.S. who are currently living with Alzheimer's disease.
The company described simufilam as "a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain." The firm explained that "altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer's pathology, neurodegeneration and neuroinflammation."
Cassava Sciences Inc. is a clinical-stage biopharmaceutical company based in Austin, Tex. The firm stated that in addition to its research and clinical work with simufilam, it is also working on developing an investigational diagnostic called SavaDx to detect Alzheimer's disease with a simple blood test.
Cassava Sciences began the day with a market cap of around $803.6 million with approximately 34.95 million shares outstanding and a short interest of about 15.6%. SAVA shares opened 45% higher today at $33.39 (+$10.40, +45.24%) over yesterday's $22.99 closing price and reached a new 52-week high today of $74.49. The stock has traded today between $32.06 and $74.49 per share and is currently trading at $70.60 (+$47.61, +207.09%).[NLINSERT]
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