Recommended

FDA tightens COVID vaccine use
Decentralised manufacturing consortium launched
Trial boost for myasthenia gravis drug
FDA starts publishing daily AE data
WEBINAR | The Future of Sterility Testing: One-Day Results with Advanced RT-rt PCR Technology | 5 NOV
WEBINAR | Mastering Impurity Profiling: USP’s Evolving Standards and Strategies | 15 OCT
news

New collaboration could transform neonatal therapy

10
SHARES

With no currently approved medicines for the prevention of bronchopulmonary dysplasia (BPD) in extremely pre-term infants, a new pharmaceutical collaboration could produce the first major therapeutic breakthrough for this patient group in decades.

OHB-607 for bronchopulmonary dysplasia

Chiesi Farmaceutici (Chiesi Group) and Oak Hill Bio, a clinical-stage neonatology and rare disease therapeutics company, have agreed to collaborate and develop, manufacture, and commercialise an investigational drug candidate for treating pre-term birth complications. OHB-607 is a human IGF-1 replacement of insulin-like growth factor-1 (IGF-1), a key driver of foetal growth and development, and its binding protein, IGFBP-3 for prevention of bronchopulmonary dysplasia in preterm infants, Chiesi explained.

 

ACCESS your FREE COPY

 


This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

Importance of the investigational treatment for pre-term infants

Until a foetus is about 30 weeks, the mother is the main source of IGF-1, which is important to note as the level of this protein is low in premature infants, due to loss of maternal source of IGF-1, Chiesi stated.

Bronchopulmonary dysplasia

Bronchopulmonary dysplasia (BPD), a chronic form of lung disease, has one of the highest unmet medical needs in the field of neonatology, according to Giuseppe Accogli, CEO of Chiesi Group. To support the immature lungs of these infants, the company highlighted that high amounts of inhaled oxygen and pressure can overstretch the alveoli. As a result, inflammation can damage the lining of the airways, the alveoli and surrounding blood vessels.

So far, clinical studies have shown that OHB-607 has the potential to significantly reduce the risk of severe bronchopulmonary dysplasia, for instance in a Phase II trial. Chiesi shared that alongside Oak Hill Bio, a Phase IIb clinical trial is planned to restart in 2024 in the US, EU and Japan.

A potential major therapeutic breakthrough

OHB-607 has the potential to be the first major therapeutic breakthrough for extremely preterm infants since lung surfactants were first approved more than 30 years ago”

“We believe that OHB-607 has the potential to be the first major therapeutic breakthrough for extremely preterm infants since lung surfactants were first approved more than 30 years ago. We hope it will lead to improved outcomes for extremely preterm infants at risk of severe bronchopulmonary dysplasia and subsequently chronic lung disease,” stated Josh Distler, President, and Chief Financial Officer of Oak Hill Bio. 

Share via
Share via