As Alzheimer’s cases increase, more people will suffer from debilitating memory loss, depression, loss of cognitive function and other painful symptoms that get progressively worse with each passing year.
That threat — paired with the fact that there is still no cure and a frustratingly limited number of treatment options with underwhelming results and harsh side effects — has motivated many pharmaceutical companies and biotechs, big and small, to explore new treatments for this complex disease.
While the bulk of Alzheimer’s research to date is grounded in the amyloid cascade hypothesis, which suggests the disease is caused by a buildup of plaque in the brain impairing cognitive functions, the clinical trials on plaque-targeting treatments have come under increased scrutiny as the drugs seem to offer minimal improvements in cognitive symptoms.
After major setbacks experienced by larger pharmaceutical companies like Biogen Inc. BIIB, Eli Lilly and Co. LLY and Pfizer Inc. PFE, scientists are calling for an expansion of medical research beyond the amyloid cascade hypothesis. These three biotechs are answering that call.
Rather than targeting amyloids, Cassava Sciences Inc. SAVA is looking at another underlying factor in the disease: misfolded proteins. Abnormal levels of misfolded proteins trigger neurodegeneration and interfere with brain function.
Simufilam, the company’s Alzheimer’s drug candidate currently under investigation, targets a scaffolding protein in the brain that helps restore the proper shape and function of misfolded proteins. Earlier clinical trials showed promising results in both improving symptoms in patients with mild-to-moderate Alzheimer’s and reducing multiple biomarkers of the disease.
Despite recent controversy following a New York Times article criticizing Cassava’s approach, the company has begun to make a recovery after information came out that the sources in the article publicly admitted to shorting Cassava’s stock leading up to the controversy and a petition to suspend Cassava’s research was denied after investigations found no evidence of data manipulation.
Two Phase 3 studies of the novel drug are underway as the company presses forward after the backlash.
SciSparc Ltd. SPRC is a specialty clinical-stage pharmaceutical company focused on cannabinoid-derived treatments for a range of conditions rooted in the central nervous system, including Alzheimer’s disease and agitation. Cannabinoids like CBD, THC and palmitoylethanolamide (PEA) have all shown the potential for the management of agitation and aggression in Alzheimer’s disease
Alzheimer’s disease is a neurodegenerative disease that causes progressive and disabling impairment of cognitive functions including memory, comprehension, language, attention, reasoning and judgment. Neuropsychiatric symptoms like apathy, social withdrawal, disinhibition, agitation, psychosis, insomnia, poor appetite and wandering are also common in the mid to late stages.
According to the Alzheimer’s Research UK, Alzheimer’s disease or mixed dementia (Alzheimer’s disease + Vascular Dementia) accounts for over 2/3 of all dementia(s) with the majority of AD patients' manifest agitation and anxiety.
Currently, Alzheimer’s patients with behavioral problems like agitation, social withdrawal or psychosis are typically prescribed antipsychotics intended to treat schizophrenia and similar disorders. The off-label use of these drugs has had limited success in helping Alzheimer’s patients and comes with a host of their own unpleasant side effects.
In December 2021, the company began recruiting patients for its Phase 2a clinical trial of the drug candidate, which uses a mix of THC and PEA, two cannabinoids that have been demonstrated to help with mood and behavioral problems.
Another clinical-stage pharmaceutical company, Alpha Cognition Inc. ACOGF, is also breaking away from the amyloid hypothesis and looking for more immediate relief of the most debilitating symptoms of the disease.
The company’s lead drug candidate Alpha 1062 is based on an existing compound — galantamine — that has already shown success as a treatment for Alzheimer’s. The compound has demonstrated the ability to improve cognitive functions and behavior while slowing the progression of the disease. In one study, patients taking galantamine were 80% more likely to be still living independently in a three-year follow-up compared to the untreated control group.
The caveat: Galantamine carries strong and uncomfortable side effects. While not life-threatening, intense gastrointestinal (GI) distress like diarrhea and vomiting can make daily life difficult, uncomfortable and embarrassing. These adverse reactions get worse with the higher doses needed to get the most benefits from treatment.
Alpha Cognition’s drug candidate is an effort to extract those benefits of galantamine while removing the side effects. By combining the potent drug with a benzoyl ester that prevents it from binding with GI nervous system, Alpha 1062 aims to bypass those GI side effects altogether while still allowing the galantamine to be metabolized.
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