Cassava Sciences (SAVA) said Wednesday that patients who received its experimental Alzheimer’s treatment showed improved cognition after a year. But SAVA stock fell.
After a year of treatment with Cassava’s drug, simufilam, patients had a 3.2-point improvement on an 11-point scale measuring cognition. That improved from a 3-point increase at nine months, Cassava said in a news release. Generally, Alzheimer’s patients decline on this measure.
But investors questioned the results. Cassava conducted what’s known as an open-label study. This means the patient knows he or she is receiving the test drug. There’s no placebo for comparison. The company is planning to begin a Phase 3 test using a placebo in the fourth quarter.
In morning trading on the stock market today, SAVA stock tumbled 3.7% near 50.95.
SAVA Stock Falls On Alzheimer’s Results
Simufilam aims to correct the function of filamin A, a scaffolding protein in the brain. Cassava says an altered form of filamin A inhibits neurons’ function, causing degeneration and inflammation.
Cassava Chief Executive Remi Barbier said he felt “energized and encouraged” by the 12-month test results. But SAVA stock has been under pressure recently. A firm hired by short sellers accused the company of manipulating its data.
Cassava outlined the data transfer throughout the study.
Investigators at each site performed the cognitive tests on Alzheimer’s patients. They entered those results directly into a system managed by an outside company. That outside company sent baseline and 12-month data to two independent biostatisticians for analysis.
The biostatisticians reached the same conclusion regarding the test results, the company said. But Cassava didn’t offer much information on the biostatisticians. That may have also dinged SAVA stock. Both biostatisticians hold doctorate degrees and can consult on medical research. One is based in Texas and the other is in Arizona.
Simufilam Looks Safe In Testing
Simufilam continued to look safe in testing. There were no drug-related serious side effects through 12 months, Cassava said. The company noted long-term safety data are required for drug approvals. Many companies perform open-label studies after completing Phase 3 testing.
Cassava went the opposite route. The National Institutes of Health is backing the open-label study of 200 patients at 16 sites in the U.S. and Canada.
“If an experimental drug for Alzheimer’s fails to show long-term safety or any treatment benefit in a large, well-designed, open-label study, such drug is unlikely to succeed under the more rigorous conditions of a randomized, controlled trial,” the company said in its news release.
Despite the recent controversy, SAVA stock holds a best-possible Relative Strength Rating of 99, according to IBD Digital. This puts shares in the leading 1% of all stocks in terms of 12-month performance.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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