Cassava Sciences Advances Alzheimer's Drug Through High-Stakes Phase 3 Trials

On Monday, Rick Barry, the executive chairman of Cassava Sciences Inc SAVA, wrote a letter to shareholders and employees.

He said the company is in the final stages of testing its Alzheimer’s drug candidate, simufilam, with significant financial and emotional stakes.

The company is conducting Phase 3 trials to demonstrate the drug’s efficacy and safety.

Related: Alzheimer’s-Focused Cassava Sciences Faces Controversy as Key Collaborator Accused of Scientific Misconduct.

These trials, costing hundreds of millions of dollars, are essential for determining if simufilam can significantly impact the lives of Alzheimer’s patients and their families.

Cassava Sciences’ executive chairman highlights that the first Phase 3 trial, involving 804 patients, is expected to report by December 2024.

The second Phase 3 trial will include 1,125 patients and is anticipated to conclude by June 2025. Both trials are designed to rigorously assess simufilam’s effectiveness compared to a placebo. The outcome of these trials will be critical in determining the drug’s future and its potential to alter Alzheimer’s treatment.

Recently, the Board of Directors appointed Richard (Rick) Barry as Executive Chairman and the company’s principal executive officer, effective immediately. The company is searching for a new permanent CEO.

In July, Cassava Sciences engaged the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange Commission (SEC) amid ongoing investigations into the company and two senior employees.

Cassava's board formed an Ad Hoc Investigation Committee to oversee outside counsel conducting the investigation. The Committee also oversees the company's disclosures related to the investigation, the company said in an SEC filing.

The credibility of the clinical trial results for an experimental Alzheimer's drug has been called into question following a critical inspection report by the FDA.

The FDA report, which was released under the Freedom of Information Act, highlighted several issues with the clinical trial work conducted by pharmacologist Hoau-Yan Wang at the City University of New York (CUNY), reported Science.org.

Price Action: SAVA stock is trading 22.7% higher at $12.37 at last check Monday.

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