Writers: Konstantin Tumanov, Ignacio Louzan
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. 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 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% 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 healthcare 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 microhemorrhage, 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, which specializes in neurostimulation, a different approach to Alzherimer’s research. Ken Mariash, CEO, explained their approach to us: “Our new Alzheimer’s treatment, which has completed a Phase 2 trial, is based on precision non-invasive brain stimulation, using high-powered magnetic fields to induce electrical currents in the brain (...) demonstrating an 82% slowing of Alzheimer's progression on the primary endpoint" These treatments considerably minimize adverse effects, slowing the progression of the disease and offering patients better coexistence with the disease - especially in comparison to what was available in the past. Yet, the ultimate cure for Alzheimer's remains hypothetical.
An answer to the mental health crisis?
The mental health crisis seems to be an epidemic, with 'one in eight people worldwide suffering from a mental disorder,' according to the World Health Organization—a figure exacerbated by the COVID-19 pandemic. As CEO of ATAI , Florian Brand, told us, mental health issues 'include a range of conditions such as depression, addiction, and anxiety (...).
Amidst this unprecedented epidemic, you might have noticed a resurgence of interest in psychedelic treatments, particularly psilocybin, for conditions such as treatment-resistant depression. A Historic study by Johns Hopkins in 2006 has revitalized the field: it was the 'first research since the 1970s to administer a classic psychedelic (psilocybin) to drug-naïve participants.' The study revealed that 'psilocybin led to profound experiences that 67% of participants rated as among the top five most meaningful experiences of their lifetime.' Additionally, 'the single psilocybin session led to positive changes in moods, attitudes, and behavior for 14 months (and possibly longer), with 64% indicating the experience increased well-being or life-satisfaction.' The research also 'established the safety of high dose psilocybin administration,' showcasing its potential for profound therapeutic impact. (Hopkins)
In response to these promising developments, companies such as Atai Life Sciences and Otsuka are exploring the therapeutic potential of psilocybin, which, as Brand told us, 'work by inducing a neuroplasticity burst, which forms new neural connections in the brain and supports the growth and survival of neurons.' The latest studies are demonstrating 'a robust evidence base for the potential efficacy of psychedelics in treating mental health conditions, with promising response and remission rates for even the most stubborn cases such as treatment-resistant depression.'
Furthermore, in relation to psychedelics, Japanese big pharma company, Otsuka, has recently acquired psychedelic biotech Mindset Pharma for $80 million dollars. This move is particularly meaningful as it depicts a radical attitude shift from the big players on the field, seeing potential in an area that was previously considered unfruitful and dangerous. Bearing in mind that no psychedelics - with the exception of esketamine - have seen FDA approval yet, a move from big pharma into the field, with its expertise and experience, might provide the final push needed for these new treatments to arrive in the market. Tarek Rabah, CEO at Otsuka NA, claims that Otsuka is 'dedicated to advancing science in mental healthcare, exploring new treatment mechanisms, including the potential of psychedelics to help treat psychiatric conditions and neurological disorders with high unmet needs.' Caution is still advised by the medical community, and drugs of the sort remain a taboo - exemplified by the fact that a person possessing at least 25 milligrams of psychedelic mushrooms or another hallucinogen can face a possible sentence of up to 15 years in prison.
Despite the challenges and societal taboos associated with these substances, the significant investments by leading pharmaceutical companies and the promising results from recent studies underscore a potentially transformative era in mental health therapy. This wave of innovation could well provide crucial breakthroughs for those suffering from some of the most challenging mental health conditions, potentially reshaping our approach to mental wellness in the decades to come.