Mediaboss Marketing

Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial

PARIS June 28, 2021 - In positive topline results from the Phase 2/3 MEDLEY trial, nirsevimab showed a similar safety and tolerability profile compared to palivizumab when administered to preterm infants or those with chronic lung disease (CLD) or congenital heart disease (CHD) entering their first respiratory syncytial virus (RSV) season.3 Safety and tolerability were assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs).

RSV, a seasonal virus that typically circulates in autumn through spring in temperate regions, is the most common cause of lower respiratory tract infections (LRTI) and the leading cause of hospitalizations in all infants.1,2,4

These data for nirsevimab are important as they show a safety and tolerability profile comparable to the only available preventative option against lower respiratory tract infections caused by RSV for preterm infants and those with health conditions, said Dr. Joseph Domachowske, Professor of Pediatrics and Professor of Microbiology and Immunology at the State University of New York, Upstate Medical Center and MEDLEY trial primary investigator. Given the typical RSV season lasts nearly five months, there is a potential advantage to providing a preventative option that could help protect all infants with one dose for the entire season.

MEDLEY is the third pivotal trial to report positive data for nirsevimab. In April, Sanofi reported that nirsevimab met its primary endpoint of achieving a statistically significant reduction of LRTI caused by RSV in healthy preterm and term infants in the Phase 3 MELODY trial. Coupled with recently published Phase 2b trial results, MELODY and MEDLEY results are part of a robust body of evidence demonstrating the potential of nirsevimab to provide RSV protection to all infants. Results from the MELODY and MEDLEY trials will be presented at forthcoming scientific congresses and, along with the Phase 2b results, will form the basis of global regulatory submissions planned for 2022.

RSV is the major remaining pediatric infectious disease with no preventative option available to all infants, said Jean-Franois Toussaint, Global Head of Research and Development, Sanofi Pasteur. We believe nirsevimab has the potential to become an important and innovative routine immunization for all infants those born prematurely or at term, healthy or with health conditions.

RSV is the leading cause of hospitalizations in infants, said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca. These results, combined with the recent positive efficacy outcome of our MELODY Phase 3 trial and our Phase 2b data, contribute to the body of evidence demonstrating nirsevimabs potential to protect all infants against RSV with one dose. We look forward to sharing the results with regulators.

Nirsevimab, being developed in partnership with AstraZeneca, is the first investigational extended half-life monoclonal antibody (mAb) aimingto protect all infants entering their first RSV season, when they are at highest risk for severe RSV disease.5-7With nirsevimab, the goal is to provide rapid and direct protection to the infant through a single immunization.

Nirsevimab is designed to be administered from birth to infants born during the RSV season or at the seasons start for infants entering their first RSV season. Incontrast to other options for RSV under development, such as maternal immunization, the aim of nirsevimab is to offer protection when needed to all infants entering their first season.

About the Phase 2/3 MEDLEY clinical trial

MEDLEY is a Phase 2/3, randomized, double-blind, palivizumab-controlled trial with the primary objective to evaluate the safety and tolerability of nirsevimab compared to palivizumab when administered to preterm infants entering their first respiratory syncytial virus (RSV) season and children with CLD and CHD entering their first and second RSV season.3 Safety is assessed by monitoring the occurrence of TEAEs and TESAEs through 360 days post-dose. Between July 2019 and May 2021 approximately 925 infants entering their first RSV season were dosed with either nirsevimab or palivizumab.

The evaluation of nirsevimab was carried out earlier than anticipated, based on sufficient enrollment, allowing for the assessment of nirsevimabs safety and tolerability versus palivizumab in infants followed through their first RSV season. The trial is ongoing to collect additional safety data in toddlers with CLD or CHD dosed prior to the second season. Results from the MEDLEY trial will be presented at a forthcoming scientific congress.

About RSV

RSV is a common, contagious virus that infects the respiratory tract, causing millions of hospitalizations globally in infants, and is the most common cause of bronchiolitis and pneumonia in children younger than one year.1,5,8-12 Hospitalization rates due to RSV infection are consistently highest in the first year of life with infants under one year representing 75% of RSV hospitalizations in children under 5 years.8,13,14 Most hospitalizations for RSV occur in otherwise healthy infants born at term.8,15 Moreover, medically-attended LRTIs are associated with increased costs to the healthcare system.16

About nirsevimab

Nirsevimab is an investigational extended half-life RSV mAb being developed as a passive immunization for the prevention of LRTI caused by RSV. It is designed to protect all infants experiencing their first RSV season and infants with congenital heart disease or chronic lung disease entering their first and second RSV season.3,17

Nirsevimab is developed with the goal of providing RSV protection via an antibody given directly to an infantto help prevent LRTI caused by RSV, unlike active immunization, where a persons immune system is activated to prevent or fight infection through a vaccine.18 Passive immunization could offer rapid protection.18

In March 2017, AstraZeneca and Sanofi announced anagreementto develop and commercialize nirsevimab. Under the terms of the agreement, AstraZeneca leads all development activity through initial approvals and retains manufacturing activities and Sanofi will lead commercialization activities.Nirsevimab is currently under clinical investigation and its safety and efficacy have not been reviewed by any regulatory authority.

Editors note: In January 2021, nirsevimab received the Promising Innovative Medicine (PIM) Designation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA)and was also granted the Breakthrough Therapy Designation (BTD) by the China Center for Drug Evaluation (CDE) under the National Medical Products Administration.In February 2019, the US Food and Drug Administration grantedBreakthrough Therapy Designationfor nirsevimab for the prevention of LRTI caused by RSV, and the European Medicines Agency (EMA) granted access to itsPRIority MEdicines (PRIME) schemefor the same indication.In Japan, nirsevimab was also selected by the Japan Agency for Medical Research and Development (AMED) as a medicine for prioritized development under the Project for Drug Selection to Promote New Drug Development in Pediatrics.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Investor Relations Contacts ParisEva Schaefer-JansenArnaud DelepineNathalie Pham

Investor Relations Contacts North AmericaFelix LauscherFara BerkowitzSuzanne Greco

IR main line:Tel.: +33 (0)1 53 77 45 45investor.relations@sanofi.com

https://www.sanofi.com/en/investors/contact

1. Leader S, Kohlhase K. Respiratory syncytial virus-coded pediatric hospitalizations, 1997 to 1999. The Pediatric infectious disease journal. 2002;21(7):629-32.2. McLaurin KK, Farr AM, Wade SW, Diakun DR, Stewart DL. Respiratory syncytial virus hospitalization outcomes and costs of full-term and preterm infants. Journal of perinatology : official journal of the California Perinatal Association. 2016;36(11):990-6.3. Clinicaltrials.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 June 2021. 4. R K. Respiratory Syncytial Virus Vaccines. Plotkin SA, Orenstein WA, Offitt PA, Edwards KM, eds Plotkins Vaccines 7th ed Philadelphia. 2018;7th ed. Philadelphia:943-9.5. 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: 94658.6. Sanofi Pasteur. Data on file. Sanofi Pasteur MarketScan Internal Analysis7. Rose E B et al. Respiratory Syncytial Virus Seasonality United States, 20142017. MMWR Morb Mortal Wkly Rep. 2018;67:71768. Rha B et al. Respiratory Syncytial VirusAssociated Hospitalizations Among Young Children: 20152016. Pediatrics. 2020;146(1):e20193611.9. Hall CB. The Burgeoning Burden of Respiratory Syncytial Virus Among Children. Infect Disord Drug Targets. 2012;12(2):92-9710. Reeves RM et al. Estimating the burden of respiratory syncytial virus (RSV) on respiratory hospital admissions in children less than five years of age in England, 2007-2012. Influenza Other Respir Viruses. 2017;11(2):122-12911. Piedimonte G, Perez MK. Respiratory Syncytial Virus Infection and Bronchiolitis. Pediatr Rev. 2014;35(12):519-53012. Oymar K et al. Acute bronchiolitis in infants, a review. Scand J Trauma Resusc Emerg Med. 2014;22:2313. Hall CB, et al. The Burden of Respiratory Syncytial Virus Infection in Young Children. N Engl J Med. 2009;360(6):58859814. Hall CB, et al. Respiratory syncytial virus-associated hospitalizations among children less than 24 months of age. Pediatrics. 2013;132(2):e341-e34815. Arriola CS, Kim L, Langley G, Anderson EJ, Openo K, Martin AM, et al. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15. Journal of the Pediatric Infectious Diseases Society. 2020;9(5):587-95.16. Leistner R, et al. Attributable Costs of Ventilator-Associated Lower Respiratory Tract Infection (LRTI) Acquired on Intensive Care Units: a Retrospectively Matched Cohort Study. Antimicrobial Resistance and Infection Control, vol. 2, no. 1, 4 Apr. 2013, p. 13., doi:10.1186/2047-2994-2-1317. 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 June 2021.18. Centers for Disease Control and Prevention. Vaccines & Immunizations. August 18, 2017. https://www.cdc.gov/vaccines/vac-

View original post here:
Nirsevimab shows positive topline results in RSV Phase 2/3 - GlobeNewswire

The weight-loss device stops users from eating solid food by locking their mouths almost shut. Photo / Supplied

A new weight-loss device which uses magnets to stop people opening their mouths enough to eat solids has been labelled "creepy and bizarre" by critics.

But Dunedin researchers who developed the device are defending the invention, saying those panning the weight loss tool have misunderstood its intention.

Otago University and United Kingdom researchers developed the world-first device, which uses magnets to lock the mouth almost shut, to help fight the global obesity epidemic.

DentalSlim Diet Control is an intra-oral device fitted by a dental professional to the upper and lower back teeth.

It used magnetic devices with unique custom-manufactured locking bolts.

The device was being widely ridiculed after being shared on social media, with Twitter users calling it "creepy" and "bizarre".

Lead researcher, University of Otago Health Sciences pro-vice-chancellor Prof Paul Brunton, said it was not intended to be used for general weight loss purposes, but instead for specific cases where there was a clinical need to lose weight quickly.

"Sometimes the first step [of losing weight] is quite difficult ... so it was developed with a view of being an additional treatment that could be used in selected cases where it's appropriate."

Brunton said feedback from colleagues in the field had been positive.

The device allows the wearer to open their mouths only about 2mm, restricting them to a liquid diet, but it allows free speech and does not restrict breathing.

Participants in a Dunedin trial lost an average of 6.36kg in two weeks and were motivated to continue with their weight loss journey.

It would be fitted by a dentist, and could be released by the user in case of an emergency and could be repeatedly fitted and removed.

"The main barrier for people for successful weight loss is compliance and this helps them establish new habits, allowing them to comply with a low-calorie diet for a period of time."It really kick-starts the process.

"It is a non-invasive, reversible, economical and attractive alternative to surgical procedures," Prof Brunton said.

The tool could be particularly helpful for those having to lose weight before they can undergo surgery, and for diabetes patients for whom weight loss could initiate remission, he said.

The practice of surgically wiring people's jaws shut became popular in the 1980s, but it came with risks; vomiting brought with it the risk of choking and after nine to 12 months the patients developed gum disease.

In some cases, there were continuing issues with restriction of jaw movement and some developed acute psychiatric conditions.

"Alternative strategies are required which may obviate surgery, or which reduce weight prior to surgery and so make it easier and safer.

"The beauty of it is that once patients are fitted with the device, after two or three weeks they can have the magnets disengaged.

"They could then have a period with a less restricted diet and then go back into treatment."

Patients given the device described it as tolerable, though the design has since been improved.

"This could actually help a lot of people."

The research team consisted of Brunton, Dr Jithendra Ratnayake, Dr Peter Mei and Dr Arthi Veerasamy, all of Otago University, Dr Jonathan Bodansky, of Leeds, and Dr Richard Hall, of RMH Consultancy, Leeds.

The paper was published in the British Dental Journal.

Excerpt from:
DentalSlim Diet Control: Researcher defends weight-loss device after it sparks ridicule on social media - New Zealand Herald

JACKSON, MI - Stephanie Titler was at her job as a veterinary assistant when she received a message on social media from a stranger, asking if she could help with a racoon stuck on the frozen lake behind her house.

She could tell the racoon was breathing but it wasnt moving, Titler, of Jackson, said of the January 2020 incident. She said she contacted animal control and they told her they were too busy. She said, Im just watching this ice melt and eventually the raccoon is going to fall in and drown.

Titler quickly left her job in Ann Arbor and drove to Jackson to the womans house, arriving the same time animal control did.

The animal control officer and Titler could not reach the raccoon with a rabies pole, so Titler took matters into her own hands, slowly crawling onto the ice on her hands and knees, grabbing the non-moving raccoon and pulling it back to land with her.

Its actions like this that have contributed to Titler being one of five contestants in the running for a 2021 American Humane Hero Veterinary Nurse Award. Her grandmother, Sharon Gerry, nominated her for the award because of her dedication to helping animals.

Shes a fantastic person, Gerry said. She is willing to help out someone she doesnt even know, thats how passionate she is about it.

Titler showed an interest in becoming a vet when she was 8 years old and has always had a passion for animals, Gerry said, adding that Titlers dedication to animals grew when she reached high school.

Its just one thing shes always wanted to do, and she does a great job. Shes fantastic with animals, Gerry said.

Titler has worked in veterinary medicine for 13 years and has been a licensed veterinary technician since 2012. Shes currently finishing her bachelors degree in biology at Eastern Michigan University and plans to apply to veterinary school in September.

In addition to her education and veterinary care work, Titler also has volunteered in animal rescue and rehabilitation with the Jackson County Animal Shelter. Over the years, she has fostered two pregnant dogs and many cats.

Currently, Titler works as a veterinarian nurse at BluePearl Veterinary Partners in Ann Arbor. She said when the COVID-19 pandemic hit in March 2020, all general veterinary practices were closed due to Gov. Gretchen Whitmers stay home order.

The only practices allowed to stay open were emergency services, which is her line of practice. This brought in a lot of animal care services to the emergency clinics that they usually would not conduct, she said.

Ive worked at BluePearl for seven years and Ive never seen anything like that, she said.

Since the clinics have re-opened, Titler said there is still a continued back up in veterinary care. She said she usually would be scheduled for a 10-hour shift at her practice, but has been working 12-hour shifts.

Id rather work myself to the bone rather than have an animal suffer for it, Titler said.

People can vote for Titler to receive the veterinary award until Thursday, July 29, at the American Humane website. The winner will be announced as part of the annual American Humane Hero Dog Awards, which will be taped for televising on the Hallmark Channel in October.

More from MLive:

U.P. woman thinks shes won $5K in lottery, app reveals its worth $1M

Michigan reports 40 new coronavirus cases and 15 new deaths for Friday, June 25

Storms cause Ann Arbor Summer Festival to cancel shows two nights in a row

See the original post:
Id rather work myself to the bone than have an animal suffer. Jackson woman up for national award - MLive.com

Well, that was a reality check.

As the Yankees limp out of Fenway Park after a weekend drubbing by the first-place Boston Red Sox, theres no sugar coating the facts: Through 77 games, the Yankees are only three games over .500. Even if New York wins its next four games, a team some thought could win over 100 games will be on pace for just 88 wins. And thats a best-case scenario. This looks and feels like a club that will win between 84-86 games.

Introducing Yankees Insider: Get exclusive news, behind-the-scenes observations and the ability to text message directly with beat writers

That, of course, wont be good enough for the playoffs in the American League. But it sure sounds like general manager Brian Cashman will be a buyer, not a seller. If that plan unfolds, here are five starting pitchers the club could target to help in the rotation. It was an area of need before the news about Corey Kluber. Now its an absolute necessity between now and July 30.

Kyle Gibson, RHP, Rangers

2021 stats: 90 IP, 2.00 ERA, 3.31 FIP

Team control: Signed through 2022. AAV: $9.3M

Why he makes sense: Veteran thats morphed from middle-of-the-rotation starter to one of baseballs best. Poised. Likely wouldnt be overwhelmed by the moment. Has pitched entire career in the American League and with the DH present. Comes with a very reasonable contract, and could replace Kluber (for a cheaper price) in next years rotation.

Jose Berrios, RHP, Twins

2021 stats: 89.2 IP, 3.41 ERA, 3.40 FIP

Team control: Arbitration eligible in 2022, free agent before 2023 season

Why he makes sense: The best combination of raw talent and team control on this list. Getting Berrios for two pennant chases would be a steal, and something no one saw coming before this season. The Twins are a mess, but might not be one a year from now. This is the time to pounce on an All-Star caliber pitcher.

German Marquez, RHP, Rockies

2021 stats: 90.1 IP, 3.99 ERA, 3.52 FIP

Team control: Signed through 2023, with a 2024 club option. AAV: $8.6M

Why he makes sense: One stat sums up why Marquez should be a must-chase for Cashman over the next month:

Marquez at Coors Field: 348.2 IP, 4.85 ERA

Marquez on the road: 376.0 IP, 3.71 ERA

Last time I checked, Yankee Stadium is not in the Rocky Mountains. Marquez is an affordable and durable innings eater that could turn into even more if given the chance to pitch regularly outside of Coors Field.

Jon Gray, Rockies

2021 stats: 68.0 IP, 3.97 ERA, 4.20 FIP

Team control: Free agent after 2021 season

Why he makes sense: Rental. Cheap. Could perform way better outside of Coors. Always blessed with big-time stuff, but rarely shows it from start to start. This is the kind of acquisition that pitching coach Matt Blake would be tasked to work magic with. Would likely come cheap in terms of prospect cost.

Pablo Lopez, Marlins

2021 stats: 91 IP, 2.87 ERA, 3.26 FIP

Team control: Arbitration eligible in 2022, free agent before 2025 season

Why he makes sense: Only 25, Lopez has an All-Star appearance likely coming next month. Over the next few years, earning votes for the Cy Young is not out of the question. Has the kind of stuff (ground balls, swings and misses) that play in any park, including the hitter-friendly Yankee Stadium. Would cost a ton, but the Yankees have bats (Gleyber Torres? Clint Frazier?) that could interest the Marlins.

Get Yankees text messages: Cut through the clutter of social media and text during games with beat writers and columnists. Plus, exclusive news and analysis every day. Sign up now.

Please subscribe now and support the local journalism YOU rely on and trust.

Joe Giglio may be reached at jgiglio@njadvancemedia.com.

See original here:
MLB rumors: 5 starting pitchers Yankees should target in trades - NJ.com

Britney Spears at a movie premiere in 2019. She pleaded with a judge on Wednesday to end a conservatorship that has controlled her personal and business lives for years. // AFP via Getty Images, Valerie Macon

Updated June 23, 2021 at 9:22 PM ET

Addressing a Los Angeles Superior Court judge via a remote connection, Britney Spears on Wednesday afternoon made her most public statement to date about her long-running conservatorship. For over a decade, the pop star's life has been ruled by an atypical court-dictated legal arrangement that removes practically all autonomy from her life. Until now, she has remained mostly quiet on the subject.

In a passionate statement to the judge, she pleaded for the conservatorship to end. According to tweets sent by observers on the scene, and some audio that was heard by NPR, Spears was sternly open and outspoken about her situation.

"I feel ganged up on, I feel bullied and I feel left out and alone," Spears said. "And I'm tired of feeling alone."

She detailed parts of her life that had been unknown. She said that she is being exploited and that she can't sleep, is depressed and cries every day.

Spears recalled one incident in which she didn't want to do an additional run of shows in Las Vegas. She felt relieved when her handlers said she didn't have to do the shows anymore but suspected there would be consequences. Days later, Spears said her therapist told her that he heard she was being uncooperative. She said he then changed her medication regimen.

In another shocking revelation, Spears said that she wanted to have another child but has been forced to keep an IUD in place.

Throughout her statement, Spears reminded the judge that it was her work financially supporting the people controlling her namely her father, Jamie Spears.

"All I want is to own my money and for this to end," she said.

The plea may be Spears' final public say on the matter. Through her lawyer, Samuel Ingham III, she said that the statement was all she wanted the public to hear and suggested that proceedings from now on be sealed.

Jamie Spears, who has been in charge of Spears' conservatorship, said through his lawyer that he's sorry to see his daughter in so much pain and that he misses her and loves her very much.

The hearing ended without resolution.

Los Angeles Superior Court Judge Brenda Penny called Spears' remarks "courageous" and said Spears would have to file a formal petition asking for the conservatorship to end before she could render a decision.

Before Wednesday, after a recent New York Times and FX documentary, Framing Britney Spears, reignited interest in her story and the wider #FreeBritney movement, she had shied away from public comment, but did share some thoughts on social media.

"I didn't watch the documentary but from what I did see of it I was embarrassed by the light they put me in," she wrote in an Instagram caption in March. "I cried for two weeks and well .... I still cry sometimes !!!!"

On Tuesday, The New York Times, citing recently obtained confidential court records, reported that Spears has been trying to fight her conservatorship for years.

"She articulated she feels the conservatorship has become an oppressive and controlling tool against her," a court investigator wrote in a 2016 report. The system had "too much control," Ms. Spears said, according to the investigator's account of the conversation. "Too, too much!"

"Ms. Spears informed the investigator that she wanted the conservatorship terminated as soon as possible. "She is 'sick of being taken advantage of' and she said she is the one working and earning her money but everyone around her is on her payroll," the investigator wrote.

"In 2019, Ms. Spears told the court that she had felt forced by the conservatorship into a stay at a mental health facility and to perform against her will."

You can find more details about the history of her conservatorship here, but these are the broad strokes:

In 2008, Jamie Spears gained control of all aspects of his daughter's life after the singer publicly struggled with her mental health. (As the Framing Britney Spears documentary brought new attention to her case, it also started some soul-searching among media types who farmed her mental health issues for tabloid headlines.) Everything from her performances to her finances to her relationships with her two now-teenage sons was under her father's control.

The pop star's fans began to question the ethics and legality of the arrangement, and under the banner #FreeBritney, they have sustained a lengthy campaign to see it end.

During this time, Britney Spears continued working putting out platinum-selling albums, doing TV gigs and mounting a hugely successful four-year residency in Las Vegas. She had no control over the financial arrangements of any of these projects.

In a 2020 court filing, Spears asked the court to suspend her father from his role as conservator and refused to perform if he remained in charge of her career. As a result, a wealth-management company became a co-conservator for her finances, but her father presently remains the main conservator for all other aspects of Spears' life.

Here is the original post:
Britney Spears Asks Court To End Conservatorship, Detailing Its Control Over Her Life | NPR - Houston Public Media