Author: Rachael Hansford

First ever Marketing Authorisation Application (MAA) for biosimilar natalizumab

Posted on July 20, 2022 by - Uncategorised

Polpharma Biologics announced on July 15th 2022 that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorisation Application (MAA) for biosimilar natalizumab, a proposed biosimilar to Tysabri®.

In the European Union, Tysabri is approved to treat adults with relapsing-remitting MS (RRMS) who have highly active disease. It is approved for adults with relapsing forms of MS in the US.

The application is for an intravenous (IV) route of administration, with the same dosing regimen, presentation and indication as the reference medicine Tysabri® – a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS).

The MAA submission was supported by a robust analytical, preclinical and clinical data package, including evidence from the Phase III Antelope study in RRMS patients (NCT04115488). 

Antelope trial results, presented at this year’s American Academy of Neurology (AAN) annual meeting, broadly showed that the biosimilar was comparable to Tysabri in terms of its efficacy at reducing inflammatory activity on MRI scans. The safety and tolerability profile of the biosimilar also was comparable to that of the name-brand medication.

Biosimilar natalizumab was developed by scientists at Polpharma Biologics and the company retains responsibility for the manufacturing and supply of the medicine. Sandoz, a division of Novartis, has the rights to commercialise and distribute the proposed biosimilar.

The acceptance of the filing of proposed biosimilar natalizumab by the European regulatory authorities means we are a critical step closer to getting this important medicine to the patients who need it the most. We are deeply proud of the dedication of our scientific teams to take biosimilar natalizumab from cell line and technical development, through clinical trials to registration – today’s milestone is testament to their achievements.

Michael Soldan, CEO

Upstaza™ – First disease-modifying treatment for AADC deficiency

Posted on July 20, 2022 by - Industry News

PTC Therapeutics to launch first gene therapy directly administered into the brain

PTC Therapeutics, Inc. announced on July 20th, 2022 that Upstaza™ (eladocagene exuparvovec) was granted marketing authorisation by the European Commission. Upstaza is the first approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency and the first marketed gene therapy directly infused into the brain. It is approved for patients 18 months and older.

“Today’s approval from the European Commission for Upstaza for the treatment of AADC deficiency is momentous for patients, for PTC, as well as for the larger gene therapy community,” said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics. “We are proud to bring this innovative therapy to the marketplace so that patients may benefit. Upstaza is the first and only approved disease-modifying treatment for patients living with AADC deficiency. We are ready to deliver this long-awaited treatment to patients as soon as possible.”

During Upstaza clinical studies, patients went from not achieving any developmental motor milestones to demonstrating clinically meaningful motor skills from as early as three months following treatment, with transformational improvements shown to continue up to ten years after treatment. In addition, cognitive skills improved in all treated patients.1,2 Upstaza also reduced symptoms that cause potentially life-threatening and morbid complications.

Before treatment, our daughter had not met any development milestones. She suffered from oculogyric crises that evolved into hours of pain, and we were told she would be bedridden for life. After receiving Upstaza, she is now speaking, walking, running, and even riding horses. We’re thrilled with the EMA approval and the hope that this milestone brings to other children and families impacted by AADC deficiency.

Richard Poulin, Patient organisation Teach RARE founder, whose daughter was treated as part of a clinical trial.

The marketing authorisation is applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein. 

References

1 Tai CH, et al. Long-term efficacy and safety of eladocagene exuparvovec in patients with AADC deficiency. Mol Ther. 2022;30(2):509-518.

2 Chien et al. AGIL-AADC gene therapy results in sustained improvements in motor and developmental milestones through 5 years in children with AADC deficiency. Poster presented at the 48th Annual Meeting of the Child Neurology Society, Charlotte, NC, USA, Oct 23-26, 2019.

3 Chien YH, et al. Efficacy and safety of AAV2 gene therapy in children with aromatic L-amino acid decarboxylase deficiency: an open-label, phase 1/2 trial. Lancet Child Adolesc Health. 2017;1(4):265-273.

About Upstaza™ (eladocagene exuparvovec)

Upstaza is a one-time gene replacement therapy indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic L‑amino acid decarboxylase (AADC) deficiency with a severe phenotype. It is a recombinant adeno-associated virus serotype 2 (AAV2)-based gene therapy, containing the human DDC gene.1 It is designed to correct the underlying genetic defect, by delivering a functioning DDC gene directly into the putamen, increasing the AADC enzyme and restoring dopamine production.2,3

The efficacy and safety profile of Upstaza has been demonstrated across clinical trials and compassionate use programmes.1 The first patient was dosed in 2010. In clinical trials, Upstaza demonstrated transformational neurological improvements. The most common side effects were initial insomnia, irritability and dyskinesia.

Administration of Upstaza occurs through a stereotactic surgical procedure, a minimally invasive neurosurgical procedure used for the treatment of a number of paediatric and adult neurological disorders. The Upstaza administration procedure is performed by a qualified neurosurgeon in centres specialised in stereotactic neurosurgery.

About aromatic L-amino acid decarboxylase (AADC) deficiency

AADC deficiency is a fatal, rare genetic disorder that typically causes severe disability and suffering from the first months of life, affecting every aspect of life – physical, mental and behavioral. The suffering of children with AADC deficiency may be exacerbated by: episodes of distressing seizure-like oculogyric crises causing the eyes to roll up in the head, frequent vomiting, behavioral problems, and difficulty sleeping.

The lives of affected children are severely impacted and shortened. Ongoing physical, occupational and speech therapy, and interventions, including surgery, also are often required to manage potentially life-threatening complications such as infections, severe feeding and breathing problems.

About PTC Therapeutics, Inc.
PTC is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialisation of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC’s ability to innovate to identify new therapies and to globally commercialise products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines. PTC’s mission is to provide access to best-in-class treatments for patients who have little to no treatment options. PTC’s strategy is to leverage its strong scientific and clinical expertise and global commercial infrastructure to bring therapies to patients.

www.ptcbio.com

National Acquired Brain Injury Strategy

Posted on July 15, 2022 by - Acquired Brain Injury

Fact finding tour to help shape Acquired Brain Injury strategy

Chris Bryant MP has visited three very different facilities offering neurorehabilitation services across the country to gather information for the new Government wide Acquired Brain Injury (ABI) Strategy.

Chris Bryant is the Chair of the All Party Parliamentary Group for ABI and the Co-Chair of the ABI Strategy Programme Board and secured the Government’s commitment to the ABI Strategy after proposing a Private Members Bill last year.

He visited Walkergate Park in Newcastle with UKABIF’s Chief Executive, Chloe Hayward, who is also the Co-Chair of the Strategy’s Patient and Public Voice Reference Group. The Tyneside Centre provides neurorehabilitation and neuropsychiatry services for adults with a disability caused by injury or disease affecting the brain or spinal cord.

There they met with both staff and patients as they were shown around the 64 bed Centre, learning about the different rehabilitation services provided and the equipment and technology available to help people affected by an ABI to live as independently as possible.

In Sheffield they visited Steps Rehabilitation Centre which provides 23 rooms for residential rehabilitation for those aged over 16 years. Everything from hydrotherapy to music therapy is used along with the latest technology to offer a range of rehabilitation to patients. There Chris and Chloe met with staff and patients to hear their thoughts on what resources are currently available and what is needed.

Finally a trip to Birmingham Women and Children’s Hospital to see what rehabilitation services are available for children. Chris met with staff, patients and families on a tour of the city centre hospital and also spoke with The Child Brain Injury Trust on the visit.

At each location staff and patients were given the opportunity to say what they thought was needed to improve the lives of those living with acquired brain injuries.

Being able to see and speak to both staff and patients means we have real life experiences from people. As Co-Chair of the Strategy’s Patient and Public Voice Reference Group I want to make sure patients’ views are taken into consideration when the Strategy is being established.

Chloe Hayward, Executive Director of UK Acquired Brain Injury Forum (UKABIF)

Chris Bryant MP said: “These visits have been hugely helpful as we look to gather information and first hand views from people working in ABI neurorehabilitation. If the ABI Strategy is to be fit for purpose we need to know what is currently working but perhaps more importantly what isn’t working in order to ensure the needs of people with an ABI are properly addressed.

“I want to say a huge thank you to everyone we met for sharing their experiences for us to consider as we take the Strategy forward.”

Birmingham Children’s Hospital
Steps Rehabilitation
Walkergate Park

Man feeds himself with robotic arms

Posted on July 14, 2022 by - Rehabilitation

Robotic arms connected directly to brain of partially paralysed man allows him to feed himself.

Recent advances in neural science, robotics, and software have enabled scientists to develop a robotic system that responds to muscle movement signals from a partially paralysed person relayed through a brain-machine interface.

Two robotic arms – a fork in one hand, a knife in the other – flank a seated man, who sits in front of a table, with a piece of cake on a plate. A computerised voice announces each action: “moving fork to food” and “retracting knife.” Partially paralysed, the man makes subtle motions with his right and left fists at certain prompts, such as “select cut location”, so that the machine slices off a bite-sized piece. Now: “moving food to mouth” and another subtle gesture to align the fork with his mouth.

In less than 90 seconds, a person with very limited upper body mobility who hasn’t been able to use his fingers in about 30 years, just fed himself dessert using his mind and some smart robotic hands.

A team led by researchers at the Johns Hopkins Applied Physics Laboratory (APL), in Laurel, Maryland, and the Department of Physical Medicine and Rehabilitation (PMR) in the Johns Hopkins School of Medicine, published a paper in the journal Frontiers in Neurorobotics that described this latest feat using a brain-machine interface (BMI) and a pair of modular prosthetic limbs.

Also sometimes referred to as a brain-computer interface, BMI systems provide a direct communication link between the brain and a computer, which decodes neural signals and ‘translates’ them to perform various external functions, from moving a cursor on a screen to now enjoying a bite of cake. In this particular experiment, muscle movement signals from the brain helped control the robotic prosthetics.

The study built on more than 15 years of research in neural science, robotics, and software, led by APL in collaboration with the Department of PMR, as part of the Revolutionizing Prosthetics program, which was originally sponsored by the US Defense Advanced Research Project Agency (DARPA). The new paper outlines an innovative model for shared control that enables a human to manoeuvre a pair of robotic prostheses with minimal mental input.

“This shared control approach is intended to leverage the intrinsic capabilities of the brain machine interface and the robotic system, creating a ‘best of both worlds’ environment where the user can personalise the behaviour of a smart prosthesis,” said Dr Francesco Tenore, a senior project manager in APL’s Research and Exploratory Development Department. The paper’s senior author, Tenore focuses on neural interface and applied neuroscience research.

Although our results are preliminary, we are excited about giving users with limited capability a true sense of control over increasingly intelligent assistive machines

Dr Francesco Tenore, a senior project manager in APL’s Research and Exploratory Development Department

Trial shows benefits in patients with Duchenne Muscular Dystrophy

Posted on July 13, 2022 by - Uncategorised

Topline Data from Phase 3 Trial shows beneficial effect of Givinostat 

22nd June, 2022: Italfarmaco Group announced positive topline data from its completed Phase 3 EPIDYS trial with Givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor, in boys with Duchenne Muscular Dystrophy (DMD). The primary objective of the study was to evaluate the effects of Givinostat on slowing disease progression in ambulant DMD boys aged 6 years and above on chronic steroids. The study compared Givinostat to placebo and met the primary endpoint (change from baseline in the time to climb 4 stairs) following 18 months of treatment in the target population1 with key secondary endpoints consistent with the functional primary endpoint. Givinostat continued to demonstrate a tolerability profile in line with previous studies. The topline data were presented by Italfarmaco Group’s Chief Medical Officer, Dr. Paolo Bettica on June 25, 2022, at the hybrid Parent Project Muscular Dystrophy (PPMD) Annual Conference.

In October 2020, the US Food and Drug Administration (FDA) granted a Rare Pediatric Disease designation to Givinostat for the treatment of DMD. Earlier, the company also received an Orphan Drug Designation from the FDA and EMA, and a Fast Track designation from the FDA. Based on the study results, which show that the addition of Givinostat to steroid treatment leads to clinical benefits for the individuals in the study, the company plans to meet with US and EU regulators to discuss the potential for marketing application submission and seek input on a future submission of the application for regulatory approval. The company intends to submit the complete results of the EPIDYS study for publication in a peer-reviewed journal in due course.

The EPIDYS Phase 3 clinical trial is a randomised, double-blind, placebo-controlled, multicentre study evaluating the efficacy and safety of Givinostat in individuals with DMD (Cinicaltrials.gov: NCT02851797). The trial enrolled 179 male ambulant individuals with a mean age of 9 years and on stable steroids for at least 6 months. Boys were randomised 2:1 and treated chronically with an oral suspension of Givinostat or placebo for a period of 18 months. Of these, 120 boys formed the target population1.

Overview of Clinical Results

Primary Endpoint: 

The mean change from baseline to climb 4 stairs was selected as the primary endpoint to assess the efficacy of Givinostat compared to placebo. The results demonstrated a slower decline to perform this functional task in the Givinostat-treated group (difference vs Placebo of 1.78 seconds, p=0.0345).

Key Secondary Endpoints: 

A variety of secondary endpoints were analysed that showed results consistent with the functional primary endpoint. These included functional tests such as the North Star Ambulatory Assessment (NSAA) and the time to rise (TTR) test along with muscle strength analyses. Fat infiltration in the vastus lateralis (VL) muscle of the thigh is a characteristic of disease progression in DMD patients and was measured using a non-invasive objective imaging method called Magnetic Resonance Spectroscopy (MRS) to assess the efficacy of Givinostat. The data indicated that treatment with Givinostat delayed fat infiltration by approximately 30% (difference vs Placebo, -2.9%, nominal p=0.035). Additional exploratory endpoints were also analysed in the clinical study. These results further support the potential of Givinostat in providing a clinical benefit for boys with DMD.

Safety and Tolerability: 

The majority of Adverse Events (AE) were mild to moderate in severity (95%). Three (2.5%) boys treated with Givinostat withdrew from the trial because of an AE. Similar to what had been previously observed, the AE occurring in at least 1/10 subjects were diarrhea, abdominal pain, thrombocytopenia, hypertriglyceridemia, platelet decrease and triglyceride increase. Givinostat tolerability was managed with appropriate monitoring and dose adjustments. No other safety concerns were observed.

These results show Givinostat’s beneficial effect in DMD boys providing evidence of its ability to slow down disease progression.

Prof. Eugenio Mercuri, Professor of Paediatric Neurology at the Catholic University, Rome, Italy

Prolonged release capsules for pain

Posted on July 12, 2022 by - Pain

Neuraxpharm launches Tapimio® (tapentadol) prolonged release capsules in the UK

Neuraxpharm announced on June 30th 2022 the launch of Tapimio® (tapentadol) for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics. Tapimio® is the first and only prolonged release capsule formulation of tapentadol to be made available in the UK.1,4,5

Tapentadol is a centrally acting analgesic which has a dual mode of action to produce acute and chronic pain relief.6 As Tapimio® is a capsule it can be taken whole or opened and the contents sprinkled on cold, soft food.1 This formulation gives adult patients with chronic severe pain which can be adequately managed only with opioid analgesics and who cannot swallow tablets or prefer capsules an alternative dosage form.

Tapimio® has demonstrated equivalent efficacy and safety to tapentadol medicines which are available in tablet form.2 Tapentadol showed superior quality of life results compared to oxycodone controlled release – a commonly used opioid.7 Tapimio® also confers a minimum cost saving of 15% to the NHS compared to existing Palexia (tapentadol) products available in the UK.3

One in four (26%) UK adults are living with chronic pain, and 24% of those are currently taking opioid painkillers.8

This is the first time tapentadol has been made available in capsule form and we are delighted to finally be bringing it to the UK market. It’s a critical time for the NHS when it comes to saving money, so we’re glad to also be able to offer this cost benefit to the NHS.

Craig Bowen, General Manager, Neuraxpharm UK

References

  1. Tapimio 150mg prolonged-release capsules. Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/13719/smpc#gref. Accessed: June 2022  
  2. Data on File. Tapentadol Bioavailability REF CSR 021B19-0522 (M). 
  3. BNF. Available from: https://bnf.nice.org.uk/medicinal-forms/tapentadol.html. Accessed June 2022.
  4. Ationdo SR 100mg prolonged release tablets. Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/12658/smpc#gref. Accessed: June 2022
  5. Palexia 50mg film-coated tablets. Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/5159/smpc#gref. Accessed: June 2022
  6. Zajączkowska, R., et al. Pharmacol Rep 2018; 70(4), pp.812-820. Available from: https://link.springer.com/article/10.1016/j.pharep.2018.01.005
  7. Lange, B., et al. Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain. Adv Ther 2010; 27(6), pp.381–399. Available from: https://link.springer.com/article/10.1007/s12325-010-0036-3.
  8. IPSOS Chronic Pain Survey. Carried out on behalf of the BBC. 9-14 March 2022. Available from: https://www.ipsos.com/sites/default/files/ct/news/documents/2022-05/chronic-pain-survey-tables-ipsos-research-for-bbc-may-2022.pdf Accessed: June 2022

Preserving cognitive function in RRMS

Posted on July 5, 2022 by - Multiple Sclerosis

Bristol Myers Squibb presents new data showing effect of early Zeposia (ozanimod) treatment in improving and preserving cognitive function in people with Relapsing Multiple Sclerosis.

On June 24th, Bristol Myers Squibb presented results of the DAYBREAK open-label extension trial at the 8th European Academy of Neurology Congress in Vienna, Austria.

New post-hoc analyses from the Zeposia (ozanimod) Phase 3 DAYBREAK open-label extension (OLE) and Phase 3 SUNBEAM trials, showed early Zeposia use demonstrated cognitive benefits in people with relapsing multiple sclerosis (MS), with the greatest effect seen in people with high thalamic volume (TV), supporting an association between preserved brain volume (BV) and improved long-term cognitive outcomes.

Multiple sclerosis can lead to significant, irreversible brain volume loss and decreased cognition if not treated quickly upon diagnosis. These new analyses show the potential of early treatment with Zeposia to help stabilize and even improve cognition in people with multiple sclerosis with high brain volume, which is important for doctors and people with multiple sclerosi

John DeLuca, PhD, senior vice president for research and training, Kessler Foundation, and professor, Department of Physical Medicine & Rehabilitation and of Neurology, Rutgers New Jersey Medical School

In these new exploratory analyses, Zeposia treatment showed improved or preserved cognitive function in a majority of patients, with the greatest improvement seen when used early in the disease when TV remains high, supporting a positive association between preserved BV and long-term cognitive performance. Zeposia was well tolerated with more than 80% of people who started the Phase 3 SUNBEAM trial (N=399 at baseline) remaining on continuous therapy through 48 months of the Phase 3 DAYBREAK OLE study (N=326).

Findings from the new research showed that people with high versus low BV, particularly TV, had higher cognitive performance, as assessed by the symbol digit modalities test (SDMT) score, at baseline. This trend remained stable or improved over 4-5 years of Zeposia treatment, leading to improved or preserved cognitive function in almost 80% of people with high TV (SDMT improved: 45.1%; SDMT preserved: 34.4%) and approximately 66% of people with low BV (SDMT improved: 35.6%; SDMT preserved: 30.7%) at Month 48 of the Phase 3 DAYBREAK OLE study.

Aubagio study: no disease activity after 2 years

Posted on July 4, 2022 by - Industry News, Multiple Sclerosis

More than half (58% )of the people with multiple sclerosis (MS) treated with Aubagio (teriflunomide) showed no evidence of disease activity after two years on treatment, according to an Italian study.

The study, “Evolution of teriflunomide use in multiple sclerosis: A real-world experience,” was published in the Journal of the Neurological Sciences.

Aubagio is an oral disease-modifying therapy that has been approved since 2013 in the EU to treat adults with relapsing-remitting MS. It is marketed by Sanofi, which was not involved in the study.

Scientists at the University of Cagliari analysed patients who started treatment with Aubagio at their clinic between 2016 and 2020. The analysis included data for 319 patients — about two-thirds were women, and the average age was late 40s.

Most of the patients (79%) had switched to Aubagio from a different MS treatment, while for the remaining 21% Aubagio was their first MS treatment.

By the end of 2020, 240 (75.2%) of the patients were still being treated with Aubagio after a median follow-up time of nearly four years (45.7 months). Among those who stopped taking Aubagio, the median treatment duration was just under two years, and just over a third (35.4%) cited a lack of effectiveness as the reason for stopping.

Efficacy data was available for 204 patients who had taken Aubagio for at least two years. Of these, more than half (58.8%) showed no evidence of disease activity (NEDA) over two years, meaning they had no relapses, no worsening disability, and no signs of new inflammatory damage on MRI scans. NEDA was also achieved by more than half of the patients (56.8%) who remained on the treatment for three years.

The likelihood of NEDA at two years was highest for those who were younger and those who had milder disability scores and fewer relapses before starting Aubagio.

Early is better than late treatment, but late is better than never

Study authors

The researchers noted that the proportion of treatment-naïve patients increased from about 10% in 2016 to roughly 30% in 2020.

The proportion of patients who were women under age 45 — so-called “childbearing age” — also increased, from about 20% in 2016 to about 30% in 2020. Aubagio is not recommended for use in pregnancy. The researchers noted that 82.3% of the women under 45 in this study already had children before starting Aubagio.

News source: Multiplesclerosistoday.com

Novel Early Intervention Study for Stroke Patients

Posted on July 4, 2022 by - Industry News, Rehabilitation, Stroke

MindMaze and The University of Auckland partner on novel early intervention study for stroke patients, expanding global breadth of research supporting the company’s brain tech solutions

MindMaze, (digital therapeutics (DTx) for neurological recovery and care), in partnership with The University of Auckland, has announced a new interventional study that will aim to show the merits of early, immersive, and intensive intervention to recover movement for patients who have experienced a stroke. The Phase 2 trial, Enhancing Spontaneous Recovery After Stroke Study (ESPRESSo, ACTRN12620000871943), will evaluate the effect of the use of MindPod in a three-week programme of high-intensity, high-dose exploratory arm and hand movements initiated within two weeks of stroke on upper limb motor capacity.

ESPRESSo is actively recruiting, orienting the medical community towards earlier intervention by demonstrating the marked benefits it can have following a stroke, both immediate and long-term.

The MindPod, a novel, immersive neuro-animation experience designed to promote the recovery of motor skill and cognitive function following a stroke or other neurological injury or disease, was chosen for ESPRESSo as it takes a unique approach to brain repair: it is a holistic multiscale intervention that simultaneously delivers a cognitive challenge, motor skill training and a cardiovascular workout. This training can be expected to lead to more generalised effects that are both cognitive and physical.

“Research shows that an injured brain can get better, especially if the recovery work starts early.

John Krakauer, M.A., M.D., Professor of Neurology, Johns Hopkins University School of Medicine

“MindPod was designed with this knowledge in mind and the result is a high-dose, high-intensity solution that patients actually enjoy using,” said John Krakauer, M.A., M.D., Professor of Neurology, Johns Hopkins University School of Medicine and Chief Medical Advisor to MindMaze. “This immersive, reinforcing environment is key for motivation and therapy adherence, each of the utmost importance in particular in early recovery settings when morale is most challenged.”

In addition, the ESPRESSo Trial is utilising a pioneering predictive tool which allows accurate predictions about recovery about three-month outcomes of upper limb function by combining clinical and neurophysiological assessments. Used in New Zealand hospitals, the tool is being validated in the United States, and is a useful and unprecedented reference for physicians when guiding their patients through what can be expected during the recovery process and eventual outcomes. In the difficult and uncertain time following an event like a stroke, the tool can provide more certainty and realistic possibilities for patients and their physicians to work towards.

“What we are evaluating in the ESPRESSo Trial is ambitious, multifaceted, and novel,” said Winston Byblow, PhD, Director of the Movement Neuroscience Laboratory at The University of Auckland and Principal Investigator on the ESPRESSo Trial. “Our aim is to show that there is a real, sound biological reason for urgency of intervention and that it directly correlates with improved outcomes for patients who have experienced a stroke. With the predictive tool, we’re meeting each patient where they are, getting the goals right early and working with state of the art, immersive technology to meet or exceed their predicted outcome.”

DTx protocols enabled by the MindPod are the subject of many ongoing trials worldwide for indications such as stroke, Parkinson’s disease, dementia and healthy ageing, underscoring its potential for more general use in neurological disease, injury and ageing.