Tag: Chiesi group

Oak Hill Bio and Chiesi Group have launched a groundbreaking study of a revolutionary bronchopulmonary dysplasia treatment for extremely premature infants.

Oak Hill Bio, a company specialising in treatments for neonatology and rare diseases, and Chiesi Group, an international biopharmaceutical firm, have announced the enrolment of the first European patient in their Phase 2b clinical study for OHB-607, a drug aimed at preventing bronchopulmonary dysplasia (BPD) in extremely premature infants.

This marks a significant step in the effort to develop a bronchopulmonary dysplasia treatment, a serious lung condition currently lacking approved therapies, and could bring about the first major respiratory therapeutic breakthrough for extremely preterm infants in over thirty years.

Victoria Niklas, Chief Medical Officer at Oak Hill Bio, shared her excitement: “As a neonatologist, I am thrilled that we have restarted this groundbreaking clinical trial. OHB-607 has the potential to improve outcomes for infants born extremely prematurely. At Oak Hill Bio, we are committed to advancing neonatology and delivering the best possible care and outcomes to infants, together with our partners at Chiesi.”

Diego Ardigò, Executive Vice President of Global Research & Development at Chiesi Group, emphasised the importance of this collaboration: “The restart of this study marks a significant step forward, highlighting our shared commitment to finding solutions for extremely premature infants, now including patients from Europe. Addressing the medical needs of these infants is not just scientific inquiry; it is a moral imperative to safeguard their well-being.”

Understanding BPD

Bronchopulmonary dysplasia is the most common complication of prematurity, affecting 40-50% of infants born before 28 weeks of gestation. It leads to chronic lung disease and can result in long-term health issues, including increased mortality, hospitalisation, and neurodevelopmental disabilities. OHB-607 has the potential to foster lung development and reduce these risks.

Details of the Phase 2b clinical study

The Phase 2b study is a multicentre, randomised, open-label trial designed to assess the efficacy and safety of OHB-607 compared to standard neonatal care. It aims to enrol at least 105 infants across Europe, including Finland, Germany, Ireland, Italy, Netherlands, Portugal, Spain, and the UK.

The remaining infants will be enrolled from North America and Japan, resulting in a total of at least 338 participants in this global study. OHB-607 will be administered by continuous intravenous infusion from 24 hours after birth until 30 weeks postmenstrual age, alongside standard neonatal care.

The primary goal of the study is to reduce the incidence of severe BPD or death by 36 weeks postmenstrual age. The study will also look at longer-term outcomes, such as the need for respiratory support up to 12 months corrected age, neurodevelopment, and other complications of prematurity like brain bleeding and vision impairment.

Mechanism of OHB-607

OHB-607 is a recombinant form of human insulin-like growth factor-1 (IGF-1) complexed with its main binding protein. IGF-1 is crucial for the growth and development of vital organs, including the lungs, eyes, and brain. Infants born before 28 weeks of gestation often have low levels of IGF-1, which can lead to underdeveloped organs. By restoring IGF-1 levels to those found in full-term pregnancies, OHB-607 aims to support normal organ development.

For additional information and to learn more about the trial registration, please visit https://clinicaltrials.gov/study/NCT03253263.

Premature births disrupt the expected narrative of a pregnancy, intertwining vulnerability with resilience.

In their campaign, Unscripted Beginnings. A Fragile Start, a Strong Future, Chiesi – an international biopharmaceutical group headquartered in Parma, Italy – sheds light on the unique challenges and hopes surrounding premature births.

Following World Prematurity Day on November 17, the campaign spotlights the experiences of families, healthcare professionals, and the pivotal role of neonatal intensive care units (NICUs).

Philip Breesch, Executive Vice President of Franchise Care at Chiesi, and Giulio Di Sturco, director of The Edge of Life – an immersive documentary supported by Chiesi, with a pre-launch slated as part of the campaign, discuss this initiative.

What is the main objective of the Unscripted Beginnings campaign?

Philip Breesch: The Unscripted Beginnings campaign aims to raise awareness about the significant issue of prematurity, highlighting both the harsh realities and the hopes that exist within NICUs.

There are over 13 million preterm births annually, 1 in 10 babies, and related deaths account for 1 million. We want to educate the public about the challenges faced by premature infants and their families, drawing attention to their unique experiences.

By showcasing both the fragility and resilience of these babies, we emphasise the critical importance of specialised care in providing them with a strong start and a brighter future.

How does Chiesi support the neonatal medical community?

Philip Breesch: Chiesi has been deeply committed to neonatology for over three decades, working tirelessly alongside healthcare professionals to improve outcomes for premature infants.

Through strategic partnerships, we continuously invest in groundbreaking research and innovative treatments that enhance neonatal care.

By sharing best practices and fostering knowledge exchange, we aim to empower NICU teams and support Patient associations and families during their challenging journeys.

Our unwavering dedication has contributed to improved survival rates and health outcomes for preterm infants across more than 80 countries around the globe.

The Edge of Life provides a unique look inside the NICU. Can you share what inspired this project?

Giulio Di Sturco: The project started unexpectedly on a vacation in Tuscany, where I met Charles Roehr, a neonatology expert from Bristol’s Southmead Hospital.

His insight, especially after recognising my premature daughter’s distinctive pacifier, sparked an idea: to document the emotional and challenging world of neonatology.

Originally conceived as a photography project, it evolved after a week in Bristol’s NICU, where I realised film could capture its essence – the sounds, time distortion, and emotions in the “Bubble”, as staff call this surreal and almost timeless space.

Additionally, using formats like 360-degree footage from incubators, the project simulates the perspective of a newborn.

What is the main objective of the documentary, and what message do you hope to convey to viewers?

Giulio Di Sturco: The goal is to provide an intimate look into the intensity of premature neonatal care, touching not just on medical aspects but also on the emotional journey of those involved.

We want to reveal what happens, which few truly know unless they’ve experienced it. My aim is to bring people into this “Bubble,” to convey the intensity and dedication of doctors, nurses, and families. It’s also a way to give back what was given to me.

Chiesi Group has been named one of the 25 World’s Best Workplaces™ in 2024 by Great Place To Work® (GPTW) and Fortune magazine, ranking 23^rd on this year’s list.

This is the first time that Chiesi has been included in the GPTW global list, making it the first Italian company to achieve this honour.

Headquartered in Parma, Italy, the Group has 31 affiliates worldwide and employs over 7,000 people, 56% of whom are women. More than 1,300 employees are dedicated to R&D.

“We are immensely proud to be the only European pharmaceutical company included in the World’s Best Workplaces™ rankings. Being part of such a selective global list of only 25 companies is a source of huge motivation for continuous improvement,” said Giuseppe Accogli, Chief Executive Officer of Chiesi Group.

“This placement stems from our firm commitment to our people’s well-being, as it reflects their direct feedback and contribution to shaping Chiesi into a place where we all enjoy working. I believe this accolade will further increase our sense of pride and belonging to a company fully dedicated to serving patients around the world in everything we do.”

World’s Best Workplaces recognises outstanding employers

Great Place To Work^® and Fortune’s annual list selects 25 global organisations that participated in Great Place To Work’s employee survey process.

7.4 million responses were received, representing 20 million employees worldwide.

To be considered for the list, companies must be identified as outstanding global employers with recognition on at least five Best Workplaces™ lists in Asia, Europe, Latin America, Africa, North America, or Australia during 2023 or early 2024.

What makes Chiesi such a successful workplace?

Reacting to the result, Giacomo Mazzariello, Chief Human Resources Officer, said: “Our talented global team is the cornerstone of our success. In all our locations around the world, we strive to create an environment where our people feel that Chiesi is their ‘Happy Place’.

“We believe in human-centred leadership, and we are committed to making every voice matter. We strive for every team member to feel empowered to make a difference by bringing their authentic selves to work and implementing policies aiming at a concrete experience of work-life balance, or as we call it, (work-) Life Harmony.

Mazzariello added: “From closing the gender pay gap to fostering a culture of well-being and innovation, we’re not just achieving a ranking, we’re working towards an even brighter future. We are aiming to make a stronger, lasting impact together with our existing talents, and the new ones that will join us over time.”

In addition to today’s recognition, in 2024, Chiesi was also ranked as one of the top 10 Best Workplaces in Europe™, and Fortune recognised it as one of the Great Places to Work in Biopharma in the US, Best Workplaces for Women™ in Greater China, UK’s Best Workplaces in BioPharma™, and UK’s Best Workplaces for Development™, among other accolades.