WWith all the recent news about a new treatment for Alzheimer’s disease (AD), the huge profits of smaller biotechs developing treatments may be lost. The excitement is understandable. Since 1998 there have been 130 failed attempts to bring AD treatment to market.
Now that the Food and Drug Administration has approved biogenic‘s (NASDAQ:BIIB) Aduhelm, despite his mixed results, theoretically made it much easier for new treatments to get the green light.
That anticipation — and positive early results — is why shares of Annovis bio (NYSEKT: ANVS) and Cassava Sciences (NASDAQ: SAVA) are both up more than 1,000% so far this year. They each offer a new way to treat Alzheimer’s that has shown promising results. These novel approaches could be the path to gains for investors willing to buy stocks while the future is still uncertain.
Unlike most AD medications, Annovis Bio’s ANVS401 is not designed to get rid of amyloid in the brain. Rather than addressing the symptom found in end-stage Alzheimer’s, the company targets the first steps of the toxic cascade. His scientists have focused on reducing a neurotoxin protein that causes nerve cell death. These proteins are valuable when the brain is slightly damaged. However, they persist when the damage is severe, interfering with the highway cells used to transport substances.
Although the phase 2 study was only set up to detect biomarkers (secondary indicators of possible improvement), preliminary data show improvements in primary function. It also works for Parkinson’s disease (PD). The study consists of 14 AD patients and 14 PD patients. In AD patients, ANVS401 led to a 30% improvement in cognition in just 25 days. There were statistically significant improvements in motor skills, coordination, and speed in PD patients. Inflammation was also reduced.
His scientists were not surprised. In four previous animal models tested for memory and learning, the drug led to full recovery in mice with AD, stroke, Down syndrome and traumatic brain injuries. The Phase 2 study continues as Annovis and the investment community eagerly await data from the remaining 40 study participants. This phase is expected to be completed in September. If previous data suggests it, the stock’s gains may just have started.
Like the Annovis Bio treatment, Cassavas Simufilam is not designed to clear amyloid from the brain. Instead, the drug restores a scaffolding protein to its normal shape. This protein – altered filamin A (FLNA) – helps build the flexible structure of cells. It’s the stuff that’s responsible for physically maintaining the brain. When it folds incorrectly, it creates inflammation like that seen in Alzheimer’s.
In February, the company announced that it had completed its Phase 2 study and received FDA approval to proceed into Phase 3. That news sent the stock soaring nearly 400% over the next few days. And that’s even after gaining more than 250% in September 2020, the month in which the first results were released. Data from this study showed that Alzheimer’s patients who received the treatment for six months had both improved cognition and behavioral scores. Cognition increased by 10% and dementia-related behavior decreased by 29%.
The company has also received multiple votes of confidence from the National Institutes of Health (NIH). Last spring, the agency awarded Cassava $2.5 million. That spring, he was awarded $2.7 million. In total, Cassava has received approximately $12 million from the NIH. With clinical advances clear and funding in place, a phase 3 trial is expected to begin later this year.
CEO Remi Barbier captured both the historic futility of AD drugs and the new hope in a recent interview when he said: “They call it the graveyard of drug development, but cancer was like that for about 30 years. In that context, despite last year’s gains, a successful attempt could result in even more massive returns for shareholders.
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Jason Hawthorne has no position in any of the stocks mentioned. The Motley Fool recommends Biogen. The Motley Fool has a disclosure policy.
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