Shares of Cassava Sciences (NASDAQ:SAVA) stock are in focus after the company announced that it would begin an open-label study on its investigational Alzheimer’s disease (AD) drug, simufilam. The trial will be eligible for patients who complete either one of its ongoing Phase 3 studies. Furthermore, the study will “generate long-term safety and tolerability data” and will see patients receive 100 mg of simufilam orally twice a day over the span of a year. Enrollments will begin this upcoming November.
President and CEO Remi Barbier added: “We believe this open-label study is the right thing to do. Alzheimer’s patients who complete one of our Phase 3 studies are eligible to enroll, knowing there is no placebo and no blinding in our open-label extension study.”
SAVA Stock: Cassava Announces Open-Label Study of Simufilam
Cassava’s ongoing Phase 3 studies for simufilam involve two double-blind, randomized, placebo-controlled studies for about 1,750 patients with mild-to-moderate AD. The drug works by seeking to restore filamin A in the brain and blood of affected patients. Trial results are expected to be released by mid-2024.
In late July, the company released positive Phase 2 preliminary data, which showed that simufilam could lead to increased cognition in patients with AD. InvestorPlace’s Louis Navellier points out that AD affects around six million Americans. By 2050, that figure could rise higher to nearly 13 million Americans.
Shares of SAVA stock received a major boost last month after it was announced that the U.S. Securities and Exchange Commission (SEC) recommended a case closing. The investigation into the company began after two physicians accused Cassava of manipulating its data using tools like Photoshop. The two individuals then filed a public petition to the U.S. Food and Drug Administration (FDA), which stated that the trials of simufilam should be suspended. In addition, they disclosed a short position in SAVA as well. At the time, Barbier denied the allegations, stating, “There is zero evidence, zero credible evidence, zero proof that I’ve ever engaged in, nor anyone I know, has ever engaged in funny business.”
The FDA eventually denied the petition, stating that enforcement actions were outside the scope of their power.
On the date of publication, Eddie Pan did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
