Cassava Sciences Inc SAVA shares were nearly doubling in value Monday following the release of a clinical trial readout.
What Happened: Austin, Texas-based Cassava announced final results of a Phase 2b study of its lead drug candidate sumifilam, which showed Alzheimer's patients treated with 50mg or 100mg of sumifilam twice daily for 28 days showed statistically significant improvements in biomarkers of disease pathology, neurodegeneration and neuroinflammation versus a placebo.
"The ability to improve multiple biomarkers from distinct biological pathways with one drug has never been shown before in patients with Alzheimer's disease," according to Cassava Sciences.
Sumifilam is a new class of drug that binds to a protein called Filamin A.
Additionally, Alzheimer's patients treated with sumifilam showed directional improvements in validated tests of episodic memory and spatial working memory versus patients on placebo, the company said.
The drug was found to be safe and well-tolerated.
"The clinical data suggest sumifilam may be slowing disease progression in Alzheimer's patients," Nadav Friedmann, chief medical officer at Cassava, said in a statement.
The study is being funded by the National Institutes of Health.
Why It's Important: The positive readout should vindicate Cassava, which saw its stock lose roughly three-fourths of its market capitalization in mid-May when topline results from a Phase 2 trial did not meet study goals.
Alzheimer's disease is a progressive brain disorder that destroys memory and thinking skills.
No drug therapies exist to reverse or halt the disease.
In the U.S., about 5.8 million people are living with Alzheimer's disease, according to Cassava.
"Filamin-binding molecules are new to Alzheimer's research and may represent an important advance if these data can be replicated in larger studies," said researcher Jeffrey Cummings, a researcher.
What's Next: Cassava said it expects to publish the study results in a peer-reviewed publication.
The company said a long-term, open-label, multi-center extension study of sumifilam 100mg twice-daily for 12 months is underway, with 50% of the target number of 100 patients enrolled.
SAVA Price Action: At last check, Cassava shares were rallying 87.8% to $6.24.
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