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Cassava (SAVA) Up on Progress With Alzheimers Disease Study

Shares of Cassava Sciences, Inc. SAVA gained 1% in the last month against the industry’s 4.2% decline.

This turnaround in the price movement can be attributed to the recent pipeline progress with lead candidate simufilam, an investigational oral drug treatment for Alzheimer’s disease dementia.

Simufilam is a novel drug candidate designed to treat and slow the progression of Alzheimer’s disease. Simufilam binds tightly to an altered conformation of the filamin A protein (FLNA) that is present in the brain of the Alzheimer’s patient and is critical to the toxicity of Aβ42.

Earlier this month, the clinical-stage biotechnology company Cassava completed patient dosing in a 6-month, randomized, controlled study of simufilam in over 125 patients with Alzheimer’s disease. This trial is known as the Cognition Maintenance Study (CMS).

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The randomized, double-blind, placebo-controlled CMS study is evaluating the safety and efficacy of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. The study follows a randomized withdrawal study design. Patients must have previously completed 12 months or more of open-label treatment with simufilam. Enrollment in the CMS was open to all patients who responded to open-label treatment as well as to all patients who had no apparent response to open-label treatment.

While phase III studies generally provide evidence of efficacy, the CMS study is also evaluating the efficacy of the drug when these patients, who had been taking simufilam for a year, stop taking it for six months. Per the company, differences that emerge between the group of patients that continued to take simufilam and the group of patients randomized to placebo may suggest evidence of simufilam’s efficacy.

Patients enrolled were randomized (1:1) to simufilam or placebo. The primary outcome measures are safety and change in cognition scores (ADAS-Cog) over 6 months in over 125 patients who completed dosing. Top-line data is expected in the third quarter.

Cassava also announced new data from European researchers that show that simufilam can reverse altered filamin A protein (FLNA) in pituitary tumor cells, leading to improved cell signaling.

However, shares of Cassava have declined 20.2% in the year so far compared with the industry’s decline of 4.2%.

 

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The recent spotlight on the Alzheimer’s Disease space has put the spotlight on companies developing treatments for the same.

We note that the FDA granted accelerated approval to Biogen BIIB and partner Eisai’s Leqembi in January 2023 to treat early Alzheimer’s Disease.

The FDA’s approval of Biogen’s and Eisai’s other Alzheimer’s Disease drug, Aduhelm, in June 2021 put this space in the spotlight. The euphoria surrounding Aduhelm, however, faded as the drug witnessed a slow launch due to reimbursement issues as its efficacy was scrutinized.

Alzheimer’s Disease is a progressive, fatal disease of the brain characterized by a decline in memory, language and other thinking skills, as well as changes in mood and behavior.

Another company that has seen a surge in share price is Prothena Corporation PRTA, whose promising Alzheimer’s Disease pipeline spans next-generation antibody immunotherapy, small molecules and vaccines.

The company earlier announced new preclinical data from its PRX012 program, a potential best-in-class anti-amyloid beta (Aβ) product candidate in development for the treatment of Alzheimer’s Disease. Data supported the profile of PRX012, which is designed to target all aggregated forms of amyloid beta with high binding potency.

Prothena is also developing a dual Aβ-Tau vaccine, PRX123, a potential prevention and treatment for Alzheimer’s Disease — to target key epitopes within Aβ and tau proteins to promote amyloid clearance and block pathogenic tau interaction.

Cassava currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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