READING, England–(BUSINESS WIRE)–Sanofi (EURONEXT: SAN and NASDAQ: SNY) and the National Institute for Health and Care Research (NIHR) have today announced that the first patient has been enrolled in the Hospitalised RSV Monoclonal Antibody Prevention (HARMONIE) study. The large European interventional clinical study is investigating protection against Respiratory syncytial virus (RSV) in infants. HARMONIE is an open label trial that will evaluate the use of nirsevimab, a passive immunisation, in a broad population. RSV is the leading cause of hospitalisation in all infants worldwidei and affects 90% of children before the age of two.ii
The study has been developed as a collaboration between NIHR, investigators, Sanofi and its clinical research organisation partner, Labcorp. More than 20,000 infants across 3 countries (United Kingdom, France, Germany) will be enrolled from August 2022 to March 2023, of which the majority (up to 12,000) will be UK infants.
The first patient visit took place at Cripps Health Centre at the University of Nottingham, United Kingdom on August 8, 2022. The study will take place across approximately 280 sites, of which around 110 are in the UK. HARMONIE is Sanofi’s first hybrid digital study, and requires only one patient visit.
Dr Simon Royal
Primary Investigator, Honorary Assistant Professor at the University of Nottingham Medical School and GP at the University of Nottingham Health Service, said:
“The HARMONIE study will expand our understanding of how well a one-off injection protects babies from RSV. RSV is a major cause of death and illness in children across the world and it is the most common reason for admission to hospital in children aged under one year in the UK. Nearly 80% of the children admitted to hospital with RSV are previously healthy and at certain times of the year, children’s wards are full of babies with disease caused by this virus.”
Professor Andrew Ustianowski,
National Specialty Lead for Infection at NIHR Clinical Research Network, said:
“This study, supported by the National Institute for Health and Care Research across over 100 sites, provides the UK with the opportunity to lead the way in a disease which impacts infants globally.
“By carrying out this widespread study, we can help discover how babies can be protected from such a common, yet potentially debilitating virus.”
Dr Bogdana Coudsy
Global Head of Medical for Vaccines at Sanofi, said:
“Given RSV is a leading cause of hospitalisation in all infants, we are excited to start this research that put the needs of participants, carers, and investigators at the heart of its development. This is an innovative study in design and execution, a model for the future, thanks to a hybrid digital design and close collaborative work.”
RSV places a significant burden on families and health services
Globally, in 2015, there were approximately 30 million cases of acute lower respiratory infections. This led to more than 3 million hospitalisations, and it was estimated that there were 60,000 in-hospital deaths of children younger than 5 years.iii-iv In recent months, there has been a resurgence of RSV following the easing of COVID-19 public health measures.v-vi
A peer-reviewed RAND and University of Cambridge report on the burden of RSV estimated that RSV costs the UK £80 million in healthcare costs and productivity losses each year.vii In 2017, RSV-related direct medical costs—including hospital, outpatient and follow-up care—were estimated at €4.82 billion globally.viii
A survey of 1,500 UK parents commissioned by Sanofi in 2021 revealed that 83% of parents said infant respiratory infections impacted their mental health, with 4 in 10 (41%) experiencing significant emotional distress.ix
Nirsevimab is being developed by Sanofi and AstraZeneca.
More information about the trial can be found at http://rsvharmoniestudy.com
Hospitalised RSV Monoclonal Antibody Prevention (HARMONIE) is a phase 3b randomised open-label study of nirsevimab in preventing hospitalisations due to respiratory syncytial virus (RSV) in infants under 12 months.
This study will include newborn babies to babies 12 months old who are in, or are approaching, their first RSV season. It will last approximately 12 months.
HARMONIE is an open label interventional study which builds on successful results in phase 2b/3 trials of nirsevimab across all infants.x Regulatory submissions for nirsevimab are already underway.
HARMONIE has been designed and developed as a result of close collaboration between Sanofi, investigators and Labcorp, with the purpose of minimising burden on participants, caregivers and parents and as such is based around a single in person visit with entirely virtual follow up.
For more information visit http://rsvharmoniestudy.com.
Nirsevimab is an investigational long-acting antibody aiming to protect all infants from birth entering their first RSV season with a single dose.x,xi,xii
Nirsevimab is an immunisation designed to provide direct RSV protection to all infants via an antibody to help prevent LRTI caused by RSV.
In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialise nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi will lead commercialisation activities and record revenues. Under the terms of the global agreement, Sanofi made an upfront payment of €120m, has paid a development milestone of €30m and will pay up to a further €465m upon achievement of certain development and sales-related milestones. The two companies share all costs and profits. Revenue from the agreement is reported as Collaboration Revenue in the Company’s financial statements.
Nirsevimab has been granted regulatory designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA) PRIority MEdicines scheme; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and named “a medicine for prioritised development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). Nirsevimab has seen successful results in phase 2b/3 trials across all infants.x The safety and efficacy of nirsevimab is currently being evaluated under an accelerated assessment procedure by the EMA. Nirsevimab has not been approved by any regulatory authority.
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
– Funding high quality, timely research that benefits the NHS, public health and social care;
– Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
– Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
– Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
– Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
– Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and potentially life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
i Verway,C, and Nunes, MC. RSV lower respiratory tract infection and lung health in the first 2 years of life. The Lancet Global Health. 2020; 8(10): E1247-E1248
ii Wennergren, G and Kristjånsson, S. Relationship between respiratory syncytial virus bronchiolitis and future obstructive airway diseases. Eur Respir J. 2001; 18:1044–1058 DOI: 10.1183/09031936.01.00254101
iii Shi T, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet 2017;390:946–58.
iv Oxford Vaccines Group. What is RSV? https://vk.ovg.ox.ac.uk/vk/rsv. Accessed August 2022.
v Ujiie M, Tsuzuki S, Nakamoto T, et al. Resurgence of Respiratory Syncytial Virus Infections during COVID-19 Pandemic, Tokyo, Japan. Emerging Infectious Diseases. 2021;27(11):2969-2970. doi:10.3201/eid2711.211565
vi CDC Health Alert Network. Increased Interseasonal Respiratory Syncytial Virus (RSV) Activity in Parts of the Southern United States. Centers for Disease Control and Prevention. June 10 2021. https://emergency.cdc.gov/han/2021/han00443.asp Accessed May 2022
vii Fusco F, et al. The impact of respiratory syncytial virus on the NHS, society and economy in the UK. RAND, May 2022. This research was commissioned and fully funded by a sponsorship agreement with Sanofi. RAND Europe and the University of Cambridge had full editorial control of and independence in the analyses performed and presented in this report, which has been peer-reviewed in accordance with RAND’s quality assurance standards. This work is intended to inform the public good and should not be taken as a commercial endorsement of any product or service. https://www.rand.org/randeurope/research/projects/impact-of-respiratory-syncytial-virus.html Accessed August 2022.
viii Zhang S, et al. Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S680-687
ix Adelphi Research Survey Commissioned by Sanofi, July 2021. Sanofi Data on File.
x Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants (MELODY). https://clinicaltrials.gov/ct2/show/NCT03979313. Accessed August 2022.
xiClinicaltrials.gov. A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus (RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children. https://clinicaltrials.gov/ct2/show/NCT03959488. Accessed August 2022.
xii Zhu Q, et al. A highly potent extended half-life antibody as a potential RSV vaccine surrogate for all infants. Sci Transl Med. 2017;9:pii: eaaj1928