Neurological & Mental Health Conditions - Q2 2021

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Neurological & Mental Health Conditions

3D sphere culture of hPSC-derived astrocytes (Engineered human neural sphere cultures can be used as relevant, high-throughput models for drug discovery and research of neurodegenerative diseases) Author: Caroline Cvetkovic, PhD. Houston Methodist Hospital

Q2 2021 | A promotional supplement distributed on behalf of Mediaplanet, which takes sole responsibility for its content

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PANDEMIC WITHIN THE PANDEMIC.

There is a global mental health crisis occurring that is affecting millions of people

We’re on a mission to revolutionize mental healthcare through the use of psychedelic therapeutics.

IN THIS ISSUE

Hopes of treatment rise for demantia patients at young age Professor Dr John C. van Swieten Director, Alzheimer Centre Erasmus Medical Centre, Rotterdam Page 04

Long-COVID: the next crisis in mental health?

Over 4 million people in the UK and over 150 million people worldwide have now been infected

by COVID-19. As a result, long-COVID is now becoming an emerging problem.

Patient care and innovation in health policy Dr Lisa Cameron MP Chair, All Party Parliamentary Group on Health (APHG) Becky Rice Health and Policy Manager, Policy Connect Page 06

The time has come to prioritise neurology as one Tadeusz Hawrot Senior Advocacy Coordinator, European Federation of Neurological Associations Page 06

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hankfully, most who catch COVID-19 make a full recovery within days, but some who survive their initial illness go on to experience long-lasting and debilitating symptoms known as “long COVID”.

According to the Office for National Statistics, one in five people have symptoms after five weeks, one in seven have them after 12 weeks, and an estimated 1.1 million people experienced long COVID in February 2021.

Common symptoms include fatigue, coughs, headaches and muscle pain. About 20% of people said these limited their day-to-day activities a lot.

The need for continued research Why do some get long COVID and others don’t? We’re not sure. For starters, there is currently no agreed definition of what we call “long COVID”, it could be several different but overlapping post-COVID syndromes.

We urgently need more research to improve our understanding and provide better diagnosis and treatment, but research takes time and there is a need for better support now.

We need to think about long COVID in the same way we think about other long-term physical health conditions like diabetes, arthritis and asthma. These have a profound impact on the lives of those affected, including on their jobs, relationships and mental health.

Impact on mental health People living with a long-term condition are two to three times more likely than the general population to experience mental illness, such as depression and anxiety.

Having more than one long-term condition increases the risk even further.

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When it comes to resourcing the NHS for after-effects of this pandemic, mental health must not be forgotten.

Without investment reaching the frontline, mental health services could be overwhelmed by long COVID patients. When it comes to resourcing the NHS for after-effects of this pandemic, mental health must not be forgotten.

We also need to break down unhelpful barriers between physical and mental health between body and mind, which are easily established. Putting patients and services into silos helps no one. What is needed is a holistic, integrated and multidisciplinary approach which puts patients at the centre of their care.

Graphs showing the peaks in cases and deaths have become grimly familiar to us all. Although in the UK we are past our recent peak, the worry is that those peaks have created a second health crisis, one that is slower burning and less visible. The reality is that the mental health consequences of this virus will be with us for years to come.

Dr Adrian James President, Royal College of Psychiatrists

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Psychedelic drugs being adapted for mental health care New treatments for patients with depression or addiction are being developed from psychedelic drugs.

S Doug Drysdale CEO, Cybin Inc WRITTEN BY Mark Nicholls

econd-generation psychedelic drugs are being developed to create new therapies for people suffering from depression or addiction. While still undergoing trials, specialists believe these medications can be an alternative to long-standing anti-depressives.

Doug Drysdale, who heads one of the companies that has taken a lead in the field, says highlighting mental health issues brought on by the COVID-19 pandemic has created opportunities for openness in discussing depression and paved the way for new treatments.

Opportunity for psychedelics Studies suggest that one in three COVID-19 survivors may suffer depression or anxiety, while around half of 18–24-year-olds have experienced depression.

“The pandemic has raised an awareness of mental health and that, combined with a willingness to explore different treatments such as plant medicines, has provided the window of opportunity for psychedelics,” says Drysdale, CEO of Cybin, which is developing psychedelic therapeutics for psychiatric disorders.

“These are the four main molecules and have been around for several decades, so we know a lot about their chemistry, safety profiles and the way they metabolise,” says Drysdale.

First-in-man trials Major institutions have been studying the effects of these molecules in comparison with traditional treatments.

Already, a study in America among 24 patients with a depressive disorder who were given two doses of a psychedelics saw 71% of participants experience a clinically significant reduction in depressive symptoms, and 54% in complete remission after four weeks.

That, he says, is “completely different” to current treatments with “moderately effective drugs”.

Drugs being developed by Cybin will target major depressive disorder and alcohol use disorder, though there is also potential for tobacco or opioid misuse.

Read more at cybin.com

Novel drug delivery technologies Research is taking place in Canada and the UK, where Cybin will conduct first-in-man trials later this year for alcohol use disorder.

Further research is being done on time it takes the drug to act in patients. “We are creating novel versions of these molecules, which still have the underlying characteristics and receptor binding abilities but with a quicker onset all while optimising duration of action

Studies suggest that one in three COVID-19 survivors may suffer depression or anxiety, while around half of 18–24-year-olds have experienced depression. of these molecules and underlying assisted therapies thus creating more scalable and commercially viable drug candidates,” explains Drysdale.

Novel drug delivery technologies to get them into the body faster include using sublingual film technology – which dissolves in the cheek or under the tongue - disintegrating tablets and inhalation. The medication forms new networks in the brain, making it more receptive to creating new memories which helps with dealing trauma, addiction and PTSD. Public re-education As psychedelic drugs also have illegal recreational connotations, Drysdale remains aware that public re-education is an important step. Although in the United States the FDA has granted breakthrough therapy for certain psychedelics, it is placing the onus on companies to show that the drugs are safe and efficacious via large randomised controlled studies before any clinical use.

In Europe there are similar regulatory hurdles to cross but globally there is a move towards decriminalising these drugs.

Investment support Cybin is a public company and has attracted investment, with the majority from significant blue chip biotech investors in the US, and the aim to have psilocybin-based therapies available by 2025.

He says: “We are literally trying to revolutionise how we treat mental illness; it is not going to be a short journey, but it is rare to see such massive opportunity in molecules we know a lot about.

“To a large extent we know these treatments work. Our job is to optimise the way they work and bring them to market in a scalable way that is safe and effective for patients.”

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Hopes of treatment rise for dementia patients at young age Frontotemporal dementia is an early-onset disease striking patients in their 50s and 60s with devastating outcomes.

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rontotemporal dementia (FTD) is a rare hereditary disease which progresses rapidly in patients. There is no recognised treatment for FTD, though a number of clinical trials for therapies are showing promise.

Neurologist John van Swieten, who is Professor in the Genetics of Dementia and Director of the Alzheimer’s Centre at the Erasmus Medical Centre in Rotterdam, has been working on the condition – also known as Pick’s disease – for almost 30 years.

It is early onset dementia with 80% of cases developing in people aged 50-65. They progressively deteriorate in five to seven years, so it is completely different from Alzheimer’s where that might be much longer.

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Genetic mutations The first mutations of the tau gene were identified in the late 1990s, before mutations in the progranulin gene were discovered in 2006.

He has produced several papers on the neuropathology of the disease after FTD patients donated their brains to the Dutch Brain Bank for research.

FTD is caused by a mutation in one of three genes - GRN, C9orf72, and MAPT – which trigger different behaviours and symptoms.

Professor van Swieten explains that with MAPt (tau) patients become often disinhibited with extreme restlessness and roaming behaviour; patients with progranulin (pGRN) manifest more with language problems; and those with C9orf72 mutations, the symptoms are forgetfulness, language issues and psychotic symptoms.

Early onset dementia He says: “The classical symptoms of frontotemporal dementia are severe behavioural changes. Later, the clinical phenotype extends to patients resembling Alzheimer’s disease with forgetfulness, to those with purely language problems, and even with Parkinsonian signs. Even the symptoms vary considerably within a family.

“It is early onset dementia with 80% of cases developing in people aged 50-65. They progressively deteriorate in five to seven years, so it is completely different from Alzheimer’s where that might be much longer.”

In families where the disease occurs, FTD may be recognised early, but in other families it often takes much longer to realise something is seriously wrong.

“It might be aggression at work or relationship problems. In patients with C9orf72 mutation and psychotic symptoms, FTD can be difficult to recognise in the early stage because there are so many other causes for that kind of behaviour,” he adds.

Genetic testing can be of value to concerned relatives who may want to find out if they have the mutation and avoid passing it on.

Professor Dr John C. van Swieten Director, Alzheimer Centre Erasmus Medical Centre, Rotterdam WRITTEN BY Mark Nicholls

Promising trials While treatment options are limited, Professor van Swieten says promising trials are targeting genes.

With pGRN, therapies are looking to restore levels of the protein in FTD patients, while with C9orf72 the focus is on genetic engineering.

Professor van Swieten’s team in Rotterdam has been following 200 healthy family members who are genetically at risk of FTD since 2010.

“We have seen changes in specific proteins in blood, but also changes on MRI one or two years before presentation of clinical symptoms” he says.

“That is important because the time window to treat patients is relatively short as after one or two years, they become too demented.”

In the Dutch research, and in European GENFI cohort co-ordinated from London, researchers have seen participants developing FTD.

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People die within 7-10 years of diagnosis because the brain is eventually destroyed, but we want to both slow the progression of the disease and begin treatment before individuals show symptoms of the disease.

Quest to combat rare form of dementia Scientists are embracing a therapeutic concept used in oncology to find a treatment for a rare form of dementia.

F Dr Arnon Rosenthal CEO and Co-founder, Alector

Dr Robert Paul Chief Medical Officer, Alector WRITTEN BY Mark Nicholls

rontotemporal dementia (FTD) is a rare disease unlike Alzheimer’s disease but runs in families and has a similar deep impact on patients and their families.

With no recognised disease-modifying treatment, FTD has become a focus for an immunoneurology approach with scientists. By targeting the brain’s immune system, scientists are attempting to alter the course of disease which leads to the condition, in the same way immunotherapy is applied in cancer patients.

Dr Arnon Rosenthal, CEO and Co-founder of Alector - which is working on a therapy for FTD - explains that there is an unmet need in FTD as no disease modifying therapies are available, the only options for patients are symptomatic treatments.

Dr Robert Paul, Alector’s Chief Medical Officer, says that Alzheimer’s disease affects millions of people, with age one of the highest risk factors. However, FTD is different, it affects some 150,000 people in Europe and America, though the actual figure could be higher.

“With FTD, other parts of the brain are affected and that affects what the symptoms are,” he says.

“The neurons that are dying are in the frontal and temporal lobe, so people start behaving differently, become depressed or aggressive and have language problems. Because FTD is so unusual, it takes a long time to diagnose these patients who are younger than Alzheimer’s patients and in their 40, 50s and 60s. Now we know that there are familial cases of FTD, ~ 40% of cases can be explained by a genetic mutation.”

Genetic composition Alector is adopting a different approach and aims to “recruit the immune system” to treat the disease, similar to immuno-oncology. Dr Rosenthal says: “Instead of trying to kill cancer cells with chemotherapy and radiotherapy, clinicians are now effectively recruiting the immune system for cancer therapy.

We are using a similar approach. Instead of trying to remove individual pathologies such as the beta-amyloid peptide, we recruit the brain immune system to combat neurodegenerative diseases.”

In the last decade, ~100,000 Alzheimer’s and FTD patients have had their genetic composition determined to assess those who have genes placing them at highest risk. This has triggered research to focus on developing drugs which functionally modulate genes which control the immune system in the brain, and utilise the brain immune system to fight dementia.

New clinical trials Progranulin is important in regulating the immune response in the brain and deficiency in the progranulin protein causes FTD. Alector is conducting a Phase III trial, to determine if the drug can alter the course of FTD in individuals with a progranulin mutation by aiming to restore progranulin levels to that of healthy individuals.

The clinical study includes both those with FTD as well as at-risk participants who have the genetic mutations and the protein deficiency but are still healthy.

Dr Paul explains that mutations in this progranulin gene lead to a progranulin deficiency that causes the disease. “We think by restoring progranulin levels, we can inhibit the disease progression.”

The impact of the disease FTD is often misdiagnosed, which Dr Rosenthal says increases the need to raise awareness of it among families, GPs and neurologists globally. “FTD is a very lethal disease,” he says. “People die within 7-10 years of diagnosis because the brain is eventually destroyed, but we want to both slow the progression of the disease and begin treatment before individuals show symptoms of the disease.”

Broad approach Results of the Phase III trial, which started in July 2020, are expected within the next few years. There is also hope that the immuno-neurology approach may work for other neurological diseases such as Alzheimer’s, Parkinson’s or Huntington’s disease.

Alector is advancing clinical trials with immunoneurology drugs also for Alzheimer’s disease, ALS (Amyotrophic Lateral Sclerosis) and Parkinson’s disease.

“We are looking at this as a broad new approach for the main neurodegenerative diseases,” says Dr Rosenthal.

“Our vision, and mission, is to make degenerative brain disorders like FTD diseases of the past.”

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The time has come to prioritise neurology as one Neurological disorders exert the highest toll measured as disease burden. We need a comprehensive framework to address them collectively.

Patient care and innovation in health policy The UK is experiencing a health care revolution driven by digital and data, promising to transform the way that we are able to diagnose, treat and cure disease.

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he COVID-19 pandemic placed the health service under the greatest pressure in its history.

It also acted as a catalyst, increasing the agility of services, embedding innovation and driving change and collaboration.

With the introduction of the NHS Health and Care White Paper, integrated care is set to become legislation; this presents an opportunity for policy makers to cement innovation and provide a better patient experience with a focus on personalised care and shared decision making.

Innovation for better care Future health innovations offer real promise for those with neurological disease; from improved diagnostics for rarer conditions to potentially curative treatments.

In the meantime, the pandemic has accelerated solutions which may provide better support for people at home. These include telehealth appointments, medication reminders, virtual neurorehabilitation and virtual wards, managing patients with equipment usually found in a specialist setting at home and using regular phone or video calls to check Future health innovations in with patients and their families. offer real promise for those

Neurology patient experience with neurological disease; Neurology patients Effective policy from improved diagnostics for To ensure that are an example rarer conditions to potentially innovation and of those with much to gain from better care is curative treatments. health innovation. available to Approximately one in six people everyone, policy makers must across the UK are living with a ensure that legislation reflects neurological condition. Neurology patient need. The All-Party Health deaths have risen steadily in Group is one forum for this. The recent years as overall mortality group provides an opportunity has fallen. to hear the voices of industry, Many neurological conditions innovators, health service leaders are chronic and/or progressive, and patients. The group is working with patients experiencing a high to scrutinise legislation and create symptom burden and a range of cross-party recommendations for unmet needs. Patients should be improved policy. supported at home but lack of expertise in the community can For more information visit policyconnect.org/aphg lead to placement in a care home.

Dr Lisa Cameron MP Chair, All Party Parliamentary Group on Health (APHG)

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Tadeusz Hawrot Senior Advocacy Coordinator, European Federation of Neurological Associations

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here are more than 400 neurological disorders, including cerebrovascular diseases and neurodegenerative diseases. Neurological disorders have the highest prevalence, biggest disability and the greatest cost among chronic disorders. They are also the fastest growing cause of deaths among non-communicable disorders (NCDs).

The financial burden should not be neglected either; the cost of treating neurological disorders in Europe alone is €336 billion annually. The neurological implications of COVID-19 make it all the more urgent to act. Neurological manifestations are being reported in around half of COVID–19 patients and are the second most common comorbidities.

Global and European response After years of neglect, neurological health is now coming out of the shadows. In 2020, WHO set up a Brain Health Unit that is currently developing an integrated response to neurology through an intersectoral Global Action Plan 2022 – 2031. In 2018, stroke was officially reclassified from cardiovascular (heart) to cerebrovascular (neurological) category of diseases. The European Union (EU) has made neurological disorders a key priority in the EU4Health Programme adopted this year.

Building on this unique momentum, in 2021 the European Federation of Neurological Associations and the European Academy of Neurology set up the OneNeurology Initiative and Partnership. It consists of international neurological organisations and regional umbrellas. We strive to make neurology a global public health priority by demonstrating what makes all neurological conditions one and developing solutions to those affected.

Time to act and to implement Neurological conditions require an integrated, stepped model of care. Prevention is hugely important; more than a third of dementias are preventable, and this figure rises to a staggering 90% for strokes.

We also see an immense lack of awareness, which in turn leads to stigma, discrimination and limited access to treatment, services and support. The recent global and EU policy developments pave a way for individual countries to prioritise neurology and work on developing national neurological plans, putting the needs of people living with these disorders at the very centre.

Becky Rice Health and Policy Manager, Policy Connect

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We also need to break down unhelpful barriers between physical and mental health between body and mind, which are easily established. Putting patients and services into silos helps no one. What is needed is a holistic, integrated and multidisciplinary approach which puts patients at the centre of their care. ~ Dr Adrian James, President, Royal College Of Psychiatrists

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With the introduction of the NHS Health and Care White Paper, integrated care is set to become legislation; this presents an opportunity for policy makers to cement innovation and provide a better patient experience with a focus on personalised care and shared decision making. ~ Dr Lisa Cameron MP, Chair, All Party Parliamentary Group on Health (APHG) ~Becky Rice, Health and Policy Manager, Policy Connect

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