Author: Rachael Hansford

New Real-World Data Support Long-Term Efficacy and Safety Profile of MAVENCLAD®

Posted on September 13, 2019 by - Industry News

Post-hoc analysis found 75% of patients from CLARITY and CLARITY Extension showed no disability progression at five years post-treatment

No new safety findings from up to 10 years of clinical programme follow-up and post-approval data following the launch of MAVENCLAD in 2017

Merck announced the presentation of new data for MAVENCLAD® (cladribine tablets), which further characterise the long-term efficacy and safety profile. These data were shared at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place from 11–13 September, 2019, in Stockholm, Sweden.

Our commitment to further understand the long-term efficacy and safety of MAVENCLAD goes beyond the safety profile seen in its clinical development programme, which includes up to 10 years of safety follow-up in some patients. The data we are presenting at ECTRIMS 2019 exemplify this. They include key insights from real-world follow-up of patients from our clinical trials and the post-approval setting for MAVENCLAD, further validating it as an important treatment option available to patients in 69 countries worldwide.
Luciano Rossetti, Head of Global Research & Development for the biopharma business of Merck 

Results from a post hoc analysis (EP1573) evaluating five-year disease stability demonstrated sustained efficacy of cladribine tablets on disability progression, as measured by the Expanded Disability Status Scale (EDSS). According to study findings, 75% of patients showed stable or improved EDSS at five years post-treatment. The exploratory analysis was based on patients treated with cladribine tablets in CLARITY and then placebo in CLARITY Extension, with at least one post-baseline EDSS measurement.

Results were presented from a retrospective analysis (P617) of real-world follow-up data from an Italian multiple sclerosis (MS) registry, consisting of patients with clinically isolated syndrome or relapsing forms of MS who received at least one course of MAVENCLAD in the original clinical trial programme. At five years after receiving the last dose of MAVENCLAD, nearly two-thirds of patients (64%) had no disability progression and more than half of the patients (57%) were free of relapse.

These data show us that MAVENCLAD continues to display sustained efficacy in a majority of patients at five years after starting treatment and that these results are consistent with data we are seeing from real-world experience. As a neurologist, this is important for me to see, as it shows that findings from the clinical development programme of MAVENCLAD will be borne out in clinical practice.
Prof. Gavin Giovannoni, a lead investigator in the CLARITY studies and Chair of Neurology, Barts and The London School of Medicine and Dentistry

In addition, final results (P1390) from the PREMIERE safety registry allowed for a thorough characterisation of the long-term safety profile of MAVENCLAD and showed no new safety findings. Furthermore, post-marketing data in the first 8,419 patients treated with MAVENCLAD worldwide were consistent with the safety profile seen in the MAVENCLAD clinical development programme, with no increase in incidence of adverse events from original clinical programme findings.

*About MAVENCLAD®

MAVENCLAD® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD® has since then been approved in 69 countries, including Canada, Australia and the U.S. Refer to the respective prescribing information for further details.

The clinical development programme for cladribine tablets includes:

The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients with RRMS.

The CLARITY extension study: a Phase III placebo-controlled study following on from the CLARITY study, which evaluated the safety and exploratory efficacy of cladribine tablets over two additional years beyond the two-year CLARITY study, according to the treatment assignment scheme for years 3 and 4.

The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).

The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding cladribine tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.

PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis) study: a long-term observational follow-up safety registry of MS patients who participated in cladribine tablets clinical studies.

In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. Adverse Events reported in other clinical studies were similar.

Imcyse to present positive results in EAE model of multiple sclerosis at ECTRIMS 2019

Posted on September 12, 2019 by - Industry News

Company’s multiple sclerosis Imotope™ shows promising preclinical efficacy and histology results while eliciting immune responses supporting the proposed mode of action and providing proof of concept

Liège, Belgium, September 12, 2019 – Imcyse, a clinical-stage company developing active and specific immunotherapeutics for the treatment and prevention of severe chronic diseases, today announces the presentation of a poster describing results obtained in the experimental autoimmune encephalomyelitis model (EAE), the widely used model for multiple sclerosis (MS).

Results of the experiments have shown an excellent inhibition of disease development, a statistically significant histological improvement and immunological markers supporting the mode of action.

The poster (P982) will be presented at ECTRIMS, Stockholm, Sweden by Dr David Walgraffe on September 12, during poster session 2, from 5:15pm to 7:15pm CEST.

Imcyse’s unique technology platform is based on specifically modified peptides (Imotopes™) which drive the generation of cytolytic CD4 T cells. These cytolytic CD4 T cells are able to actively and specifically target the immune cells involved in the pathogenesis of the respective autoimmune disease. There is potential with this therapy to disrupt undesirable autoimmune responses that drive the myelin sheath destruction and to stop disease progression in MS.

Imcyse’s MS Imotope™ is the company’s second most advanced product candidate after the type 1 diabetes (T1D) Imotope™ IMCY-0098. Imcyse is currently preparing for a phase 1-2 clinical study with an MS Imotope™.

The positive results of the Imcyse MS Imotope™ in the EAE model are very encouraging,” said Thomas Taapken, executive chairman of Imcyse. “After the positive clinical results in T1D, they further validate Imcyse’s unique technology platform.”

The MS program has received financial support from the Walloon Region (DGO6).

About Imcyse
Imcyse develops active targeted immunotherapies to treat and prevent severe chronic diseases caused by disruptions of the immune system. The company’s unique active immunotherapy technology platform allows it to locally target immune cells involved in the destruction of the diseased organ. This platform is based on the administration of Imotopes™, which are specifically modified peptides, allowing for the generation of cytolytic CD4 T cells. Imcyse’s approach, sustained over time, helps to prevent and treat diseases with no current therapeutic alternative and to potentially cure patients without impairing immune defense. The company has established proof of concept in several indications and has completed its first clinical trial in type 1 diabetes in seven European countries. Beyond type 1 diabetes, Imcyse is developing a pipeline of Imotopes™ for the treatment of several autoimmune diseases. Based in Liège, Belgium, Imcyse was originally founded in 2010 as a spin-off from the KU Leuven, Belgium.
www.imcyse.com

Improved NHS care for Parkinson’s, Multiple Sclerosis and Motor Neurone Disease to save 2,500 hospital trips

Posted on September 10, 2019 by - Industry News

People living with conditions like Parkinson’s could benefit from quicker diagnosis and better coordinated care as part of a new NHS initiative, which is also set to free up millions of pounds to reinvest in patient care.

NHS experts have joined forces with seven leading charities to produce a toolkit that will help local health groups improve services for people with conditions including Multiple Sclerosis (MS), Motor Neurone Disease (MND) and Parkinson’s, including rolling out fast-tracked blood tests and consultant appointments over Skype for those who want them.

Up to 2,500 emergency admissions to hospital a year could be avoided for patients with these conditions as a result, with up to £10 million freed up to fund improved services.

The guidance aims to help Clinical Commissioning Groups (CCGs) deliver faster diagnosis and treatment for progressive neurological conditions, better join-up the different health professionals and organisations supporting each individual, and improve access to specialist physical and mental health care.

People will also be supported to better understand and manage their symptoms at home, and to take a more informed and active role in making decisions about the treatment they receive.

Created with Parkinson’s UK, MS Society, MS Trust, MND Association, Sue Ryder, MSA Trust and PSP Association, the guidance comes as local health groups are working with staff and communities to develop their plans to join up and improve care over the next five years, to deliver the benefits for patients set out in the NHS Long Term Plan.

Dawn Chamberlain, Programme Director – Clinical Improvement at NHS England and NHS Improvement, said:

This is an opportunity for the NHS to work directly with patients and their families to deliver better care closer to home for the thousands of people with progressive neurological conditions. As they work with staff, patients and stakeholders to implement the NHS Long Term Plan, this toolkit provides the information local health leaders need to understand how to deliver high quality neurology services. Many areas are already providing high quality care in line with best practice, and by supporting others to come up to the same standard, we can deliver faster, more joined-up and better care for thousands more people – supporting them to stay well in their own homes.

The Progressive Neurological Conditions Toolkit is the latest publication from the NHS RightCare programme, which was set up to provide support to local CCGs to improve care in key areas, based on the best-available data, evidence and intelligence.

Alongside the best practice guidance, CCGs will receive extensive data on local performance, and tailored support to improve their offer to patients.

The charities who have worked closely with the NHS RightCare team to develop the toolkit will continue to support efforts to see it implemented effectively, with the shared aim of improving care for everyone living with a progressive neurological condition in England.

www.england.nhs.uk/rightcare/products/pathways/progressive-neurological-conditions-toolkit/

PathMaker Neurosystems – Publication of First Clinical Trial Results for MyoRegulator® Device for Non-Invasive Treatment of Spasticity

Posted on August 19, 2019 by - Industry News

PathMaker Neurosystems Inc. (“PathMaker”), a clinical-stage bioelectronic medicine company developing breakthrough non-invasive systems for the treatment of patients with spasticity and paralysis has announced the first publication of clinical trial results for its MyoRegulator® device for the non-invasive treatment of spasticity. Published in Bioelectronic Medicine, the results provide the first clinical evidence using MyoRegulator to treat upper extremity spasticity in subjects with chronic stroke. MyoRegulator is an investigational medical device and is limited by US Federal law to investigational use only.

Spasticity is a chronic condition characterised by painful muscle contractions and is common in patients suffering from stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury and other neurological disorders. Management of spasticity is a difficult challenge and is currently managed primarily by pharmacological agents and injected botulinum neurotoxins, and there is tremendous unmet medical need.  MyoRegulator is a first-in-class non-invasive device based on PathMaker’s proprietary DoubleStim™ technology (combining anodal trans-spinal direct current stimulation (tsDCS) and peripheral nerve direct current stimulation (pDCS)), which provides simultaneous non-invasive stimulation intended to suppress hyperexcitable spinal neurons involved with spasticity.

“Current pharmacological approaches to managing spasticity have, at best, short-term efficacy, are confounded by adverse effects, and are often unpleasant for the patient,” said co-author Zaghloul Ahmed, Ph.D., Professor and Chairman, Department of Physical Therapy and Professor, Center for Developmental Neuroscience, CUNY and Scientific Founder of PathMaker Neurosystems. “The initial study results demonstrate the potential of a novel, non-invasive treatment to reduce spasticity and improve functional recovery in patients with upper motor neuron syndrome after stroke.”

The publication, Non-Invasive Treatment of Patients with Upper Extremity Spasticity Following Stroke Using Paired Trans-spinal and Peripheral Direct Current Stimulation, was authored by researchers at Feinstein Institute for Medical Research at Northwell Health (Manhasset, NY) led by Bruce Volpe, M.D. The study included patients with upper limb hemiparesis and wrist spasticity at least 6 months after their initial stroke in a single-blind, sham-controlled, crossover design study to test whether MyoRegulator treatment reduces chronic upper-extremity spasticity.

Twenty subjects received five consecutive 20-minute daily treatments with sham stimulation followed by a 1-week washout period, then five consecutive 20-minute daily treatments with active stimulation. Subjects were told that the order of active or sham stimulation would be randomized. Clinical and objective measures of spasticity and motor function were collected before the first session of each condition (baseline), immediately following the last session of each condition, and weekly for 5 weeks after the completion of active treatments. The results demonstrated significant group mean reductions from baseline in both Modified Tardieu Scale scores (summed across the upper limb, P<0.05), and in objectively measured muscle resistance at the wrist flexor (P<0.05) following active treatment as compared to following sham treatment. Motor function also improved significantly (measured by the Fugl-Meyer and Wolf Motor Function Test; P<0.05 for both tests) after active treatment, even without additional prescribed activity or training. The effect of the active MyoRegulator treatment was durable for the 5-week follow-up period.

We are highly encouraged by these clinical results which demonstrate the potential of MyoRegulator to improve outcomes for patients suffering from spasticity, without the need for surgery or drugs. Building on these results and our ongoing clinical trial in Europe, we expect to initiate a US multi-center, pivotal, double-blind clinical trial supported by the National Institute of Neurological Disorders and Stroke (NINDS) in early 2020.

Nader Yaghoubi, M.D., Ph.D., President and Chief Executive Officer of PathMaker

About PathMaker Neurosystems Inc.

PathMaker Neurosystems is a clinical stage bioelectronic medicine company developing breakthrough non-invasive systems for the treatment of patients with chronic neuromotor conditions. With offices in Boston (US) and Paris (France), we are collaborating with world-class institutions to rapidly bring to market disruptive products for treating spasticity, paralysis and muscle weakness. In January 2019, we announced a collaboration and distribution agreement with WeHealth Digital Medicine to commercialise the MyoRegulator® device worldwide, excluding US and Japan territories retained by PathMaker.  More than 48 million patients in the US, Europe and China suffer disabilities due to stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, Parkinson’s disease and other neurological disorders. At PathMaker, we are opening up a new era of non-invasive neurotherapy for patients suffering from chronic neuromotor conditions. For more information, please visit the company website at www.pmneuro.com.

Source: PathMaker Neurosystems Inc.

Improving management of headache, migraine and chronic pain

Posted on August 1, 2019 by - Industry News, Neurology News

The Elective Care Transformation Programme’s wave 5 100 Day Challenge ran from October 2018 to the end of January 2019, with neurology as one of the focus specialities. The programme used a structured innovation method that unlocks the knowledge and skills of frontline staff and service users to accelerate the pace of change across complex systems. Teams were challenged by their senior leaders to design and test interventions within 100 days to improve neurology services. Interventions were themed across the pathway to look at rethinking referrals, shared decision making and self-management support, and transforming outpatients.

Teams in North East Essex, Salford and South West Hampshire focused on improving the management of headaches and migraine. Improved referral pathways, provision of Advice and Guidance services for GPs and better access to community headache services contributed to reducing referrals to secondary care and waiting times for treatment. Liverpool chose to address chronic pain. The team trialled a community multidisciplinary team (MDT) and found the majority of referred patients could either be discharged to the GP with advice or were suitable for a community MDT appointment.

Learning from the neurology 100 Day Challenge has been collated in the neurology specialty handbook which covers an overview of tested interventions. The handbook, supporting webinars, case studies from pilot sites, further resources and useful information can all be found on the Elective Care Community of Practice online collaboration platform. You can become a member of the Community of Practice by emailing: ECDCmanager@future.nhs.uk

IQoro for stroke-related dysphagia

Posted on August 1, 2019 by - Industry News

NICE has developed a Medtech Innovation Briefing (MIB) with advice to aid local decision making on the use of IQoro for stroke-related dysphagia. Concluding their in-depth study of the effectiveness of IQoro® in the treatment of the legacy of stroke, NICE judged it to be unique, innovative and that the intended place in therapy would be as well as standard speech and language therapy in people with stroke-related dysphagia.

In one of the scientific papers assessed and referenced by NICE in the bulletin, a group of patients with stroke that had suffered swallowing difficulties for up to ten years were treated with IQoro®. After 5 to 8 weeks’ treatment, 97% had improved their swallow, and 63% regained a normal swallowing ability.

This important news allows NHS staff to consider deploying IQoro® treatment in the post-acute, residential care, community care or domiciliary care phases as outlined by NICE in the MIB.

Neurological Alliance Report shows increasing number of neurological cases

Posted on August 1, 2019 by - Industry News, Neurology News

The Neurological Alliance has recently published a report, Neuro Numbers which shows that the number of neurological cases has now reached at least 14.7 million in England. This equates to more than one in six people living with one or more neurological conditions. The report also highlights that the prevalence of neurological conditions will continue to increase due to an ageing population, improvements in diagnosis and advances in neo-natal care. In response to this new data, The Neurological Alliance is calling for neurology to be prioritised by the health and care system to ensure the needs of this growing patient group are met.

75,000 neurological cases per Clinical Commissioning Group (CCG)

Analysis of the new data reveals that there are over 75,000 neurological cases per Clinical Commissioning Group (CCG). Data produced by NHS RightCare for local and regional commissioning areas demonstrate there is a substantial financial savings opportunity in relation to reducing emergency admissions and bed days with a mention of a neurological condition. Yet a recent audit of CCGs, undertaken by The Neurological Alliance has demonstrated that only 35 out of 195 CCGs have delivery plans that include neurological conditions. Sarah Vibert, Chief Executive of The Neurological Alliance said:

Our latest Neuro Numbers report shows that the number of people living with neurological conditions has grown over the last five years and will continue to increase. We were dismayed to find that the NHS Long Term Plan did not mention the word ‘neurology’. What is needed is increased awareness of neurological conditions among those responsible for planning services. But without any national neurological priority, many of the measures set out in the NHS Plan that have the potential to ensure people with neurological conditions are better supported may not bring about the changes needed.

National incentives for local decision makers

We are calling for the different parts of the health system to work together to address the issues being highlighted by the data. The report highlights that 2019 is set to be a landmark year for our understanding of neurological services, with Getting it Right First Time due to report on neurology in the summer. We would like to see the introduction of national incentives for local and regional decision makers to tackle unwarranted variation in neurological care, based on the opportunities for improvement demonstrated by local-level data. Katharine McIntosh, Senior Policy Advisor from The Neurological Alliance said:

The system needs to act now to address the issues the data is flagging. A year ago, it was shown that deaths from neurological conditions are 35% more likely to be premature. We know that many of these deaths are potentially avoidable with better care. Mortality data also highlights that neurology is particularly adversely affected by health inequalities – for example mortality related to epilepsy in the most deprived areas was three times higher than in the least deprived areas. We are yet to see concerted action to tackle avoidable deaths related to neurological conditions.

Read the full report at https://www.neural.org.uk/ resource_library/neuro-numbers-2019/

Initiative Launches to Match International Surgical Students with Training Posts

Posted on July 30, 2019 by - Industry News, Neurology News

A MAJOR new initiative has been launched placing international surgical trainees into posts throughout the UK’s NHS Trusts and Boards – providing vital training and much-needed personnel while boosting patient safety.

Building on previous schemes that have now helped to match up more than 1000 international medical graduates (IMGs), The Royal College of Surgeons of Edinburgh (RCSEd) has now launched the UK’s first International Postgraduate Deanery (IPD).

This will allow IMGs the opportunity to spend up to two years contributing towards patient care in the NHS, boosting training and development within the health service, with many trusts facing a challenging shortage of surgical staff against the demands of a growing and ageing population.

As the largest of the UK’s four surgical Colleges and a 26,000 strong membership across 100 countries worldwide, RCSEd will use its global span and local expertise to ensure the ideal candidates are paired with the most suitable roles, based throughout the country.

Mr Stuart Clark, International Postgraduate Dean, Member of RCSEd Council, Oral and Maxillofacial Surgeon said: “I am excited to announce the launch of RCSEd’s new International Postgraduate Deanery.

“The Deanery will offer Trusts the opportunity to provide high quality training to overseas doctors whilst utilising their skills and expertise within the NHS. RCSEd has over 25 years’ experience of delivering similar programmes and we are keen to use this expertise to continue to deliver a world class service.”

RCSEd provides training, examinations and development to medical professionals and while headquartered in Edinburgh, the College has centres in Birmingham and Kuala Lumpur to serve growing UK and international memberships.

RCSEd are conscious of the considerable value that the exchange of global surgical knowledge brings to the NHS, and intend to use the IPD to advance this. The Deanery will ensure that trainees are fully inducted to the NHS and UK practice, and equipped with the non-technical skills required to provide high quality patient care.

In turn, the College will support doctors towards achieving their training aims and ensure they are treated with the same fairness as their UK counterparts. IMGs are an invaluable asset to the NHS, and it is essential that this value is recognised.

Mr Pala Rajesh, Vice President RCSEd, Cardiothoracic Surgeon said: “I have enjoyed my role in developing the International Postgraduate Deanery, and look forward to seeing it come to fruition. The Deanery will allow the College to develop its existing international portfolio and engage with our Members and Fellows around the globe while supporting the NHS.”

Unique to RCSEd, the College will be proud to award Membership of the International Postgraduate Deanery (MIPDEd) to all trainees who successfully complete their training with the IPD, and look forward to continuing to work with MIPDEds following their return to their home country to implement the skills they have gained in the NHS.

UKABIF Film Award – deadline 20th September

Posted on July 30, 2019 by - Industry News, Neurology News, Online First

The deadline of the 20th September is fast approaching for entries to the United Kingdom Acquired Brain Injury Forum (UKABIF) Film Award 2019, sponsored by Cygnet Health Care.

The judging panel is looking for a three-minute, impactful, ‘punchy’ film that raises awareness of the benefits of neurorehabilitation after an ABI, with a specific focus on neurorehabilitation in hospital, and/or in the community, and/or in school, and/or in prison or in connection with sport.

Entries are welcome from everyone with an interest, or experience in ABI, including the rehabilitation multidisciplinary team, doctors in primary and secondary care, case managers, personal injury lawyers, social care workers, voluntary organisations, care providers and individuals with a brain injury, their families or carers, students and the general public.  The Film Award is also open to UKABIF members and non-members.

The winning entry receives £500, and will be announced no later than the 11 November 2019. For further information and an entry form visit: https://www.ukabif.org.uk/ukabif-film-award-2019-now-open-for-entries/