This Phase 2 trial showed 80 percent+ slowing of Alzheimer’s progression on gold standard cognitive and functional endpoints using non-invasive neuromodulation, leading to Sinaptica’s founding. I’ve never encountered placebo–controlled efficacy data as strong.
KEN MARIASH | CEO, SINAPTICA
Prevalence and Economic Impact
Alzheimer’s slow impairment of memory and cognitive functions continues to divide the wider scientific community, given the disease’s complex nature, involving a mix of lifestyle, genetic, and environmental factors. Seven million Americans grapple with Alzheimer’s, according to the Alzheimer’s Association. In view of an aging population and extended life spans, the figure is projected to double by 2050. The financial toll is equally impactful, as Alzheimer’s care is expected to cost $360 billion in 2024 according to the Alzheimer’s Association, rising to nearly $1 trillion by 2050.
However, investors are also up to the challenge. There has been a notable shift in investment focus towards neurological disorders in recent years. Previously, the sector was known for the hesitancy it caused in investors, who had spent billions in research on diseases like Alzheimer’s that brought little progress. But recent breakthroughs have changed this, transforming the sector into one of the most promising and attractive investment areas.
Innovative Treatment Approaches
Japanese giant Eisai, has recently been in the spotlight thanks to the launch of LEQEMBI, designed to target and clear the infamous amyloid beta plaques, known for their strong association with Alzheimer’s disease and contribution to neurodegeneration and cognitive decline. Paul Hawthorne, Executive VP and Chief Business Officer, told us about the significant benefits of their new treatment, stating that ‘we estimate that over 10 years cumulatively, the gradual adoption of LEQEMBI treatment at this pricing approach could give back about 60 percent of the potential positive social impact of several tens of billion dollars to the U.S. society.’ These savings would come from the treatment’s positive effects, such as improving health outcomes and reducing health care costs. Martin Tolar, president & CEO at Alzheon also highlighted advancements in treatment options with their drug ALZ-801, noting, ‘We have completed enrollment for the pivotal APOLLOE4 Phase 3 clinical trial of our novel oral medication, ALZ-801/valiltramiprosate, which as our data have shown, avoids certain adverse effects, such as brain edema and micro hemorrhage, that have been seen with other treatments’. This promising drug candidate might be out in the market very soon, as Tolar told us that they ‘expect to complete the pivotal Phase 3 trial this year and aim for regulatory approval shortly thereafter. If all goes according to plan, ALZ-801 could be available in the U.S. by 2025.’ Another notable example in the field is that of Sinaptica Therapeutics, which specializes in personalized neuromodulation, a novel approach to Alzheimer’s treatment. Ken Mariash, CEO, explained their therapy, which has completed a Phase 2 trial, to us: ‘Our patented new Alzheimer’s treatment is based on precision non-invasive brain stimulation, using high-powered magnetic fields to induce electrical currents in the brain. The study demonstrated an 82 percent slowing of Alzheimer’s progression on the primary endpoint, using a painless treatment with virtually no side effects’. These new approaches considerably minimize adverse effects, slowing the progression of Alzheimer’s and offering patients better coexistence with the disease. Though the ultimate cure for Alzheimer’s remains hypothetical, these new developments offer hope for patients that so desperately need it.
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About Sinaptica Therapeutics
Sinaptica Therapeutics is a clinical-stage neuromodulation therapeutics company leading the development of a new class of personalized therapeutics to revolutionize the treatment of Alzheimer’s and neurodegenerative diseases. The company utilizes a novel, noninvasive approach to treating Alzheimer’s via precision neurostimulation of a key brain network involved in memory, the Default Mode Network. This novel approach slowed disease progression by >80% on all four gold-standard cognitive and functional clinical endpoints in a placebo-controlled Phase 2 clinical study, with results published in the peer-reviewed Oxford University Press journal, Brain. The technology was granted Breakthrough Device Designation by the FDA in 2022 and the company is preparing for a pivotal randomized controlled clinical trial in early 2025. Sinaptica’s mission is to bring a safe, effective, and noninvasive neuromodulation therapy to Alzheimer’s patients that can help to significantly slow the progression of both cognitive and functional decline. Learn more at sinapticatx.com and follow us on LinkedIn and Twitter @SinapticaTX.
The SinaptiStim™ System is for investigational use only. It has not been approved by the U.S. Food and Drug Administration and is not available for commercial sale in any geography.
Media contact:
Kira Gordon, BrightPoint
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646-243-4920