- Design of multi-center study is based on previous Phase 2a
clinical data, which showed a decrease in the occurrence of severe
bronchopulmonary dysplasia (BPD)
- OHB-607 has the potential to be the first innovative
respiratory therapeutic advance for extremely preterm neonates in
over thirty years.
- Oak Hill Bio and Chiesi Group are collaborating closely to
develop OHB-607 under a license and development agreement.
Oak Hill Bio, a clinical-stage neonatology and rare disease
therapeutics company, and Chiesi, an international,
research-focused biopharmaceutical group (Chiesi Group), announced
that the first patient has been enrolled in a resumed Phase 2b
clinical study to assess the efficacy and safety of OHB-607, an
investigational drug candidate being developed to treat
complications of extremely premature birth, including
bronchopulmonary dysplasia (BPD), a serious condition for which
there are no approved therapies.
"As a neonatologist, I’m thrilled that we have restarted this
groundbreaking clinical trial previously paused during the
out-licensing process to Oak Hill Bio. OHB-607 can potentially
improve the outcomes for infants born extremely premature," said
Victoria Niklas, Chief Medical Officer at Oak Hill Bio. “At Oak
Hill Bio, we are committed to advancing the field of neonatology
and delivering the best possible care and outcomes to patients
together with our partners at Chiesi."
“The restart of this study marks a significant milestone
highlighting the shared commitment of Chiesi and Oak Hill Bio to
advance solutions for the vulnerable group of extremely premature
infants,” commented Diego Ardigò, Global Research & Development
Head at Chiesi Group. “Addressing the medical needs of these
infants goes beyond scientific inquiry; it's a moral imperative to
safeguard their well-being.”
OHB-607 is the recombinant form of human insulin-like growth
factor-1 (IGF-1), a key driver of organ growth and development
during gestation, complexed with its main binding protein
(rhIGFBP-3). A previous Phase 2a study1 demonstrated a decrease in
severe BPD and the feasibility of OHB-607 infusion. Based on these
results and the significant unmet need for therapies to reduce the
overall morbidity in extremely preterm infants, OHB and Chiesi are
excited to continue the investigation of OHB-607 for the prevention
of complications of prematurity.
About the Phase 2b Study
The Phase 2b clinical study is a multicenter, randomized,
open-label, two-arm study designed to evaluate the efficacy and
safety of OHB-607 compared to standard neonatal care for preventing
BPD and other complications of prematurity among infants born
extremely premature (between 23 and 28 weeks of gestation). The
study will open at multiple centers across the United States and
shortly extend to Japan and countries in Europe. It is designed to
enroll at least 338 infants.
OHB-607 will be administered by continuous intravenous infusion
from 24 hours after birth until 30 weeks postmenstrual age. All
infants will simultaneously receive standard neonatal care based on
the individual infant’s condition and local guidelines.
The primary endpoint of the study is the reduction in the
incidence of severe BPD or death by 36 weeks postmenstrual age
compared to extremely premature infants receiving standard neonatal
care alone. The study will also evaluate the impact of OHB-607 on
weaning from respiratory technology support through 12 months
corrected age as a longer-term respiratory outcome measure, the
impact on neurodevelopment, and the incidence of other
complications of prematurity, including intraventricular hemorrhage
(bleeding in the brain) and retinopathy of prematurity (vision
impairment and blindness). The study will utilize a modified
National Institute of Child Health and Human Development (NICHD)
score to define BPD severity grading, allowing the comparison of
infants with the most severe form of the disease.
For additional information and to learn more about the trial
registration, please visit
https://clinicaltrials.gov/study/NCT03253263
About OHB-607
OHB-607 is the recombinant form of human insulin-like growth
factor-1 (IGF-1) complexed with its main binding protein
(rhIGFBP-3). IGF-1 is a key driver of the growth and gestational
development of vital organs, including the lung, eye, and brain.
Mothers are the primary source of IGF-1 for the developing fetus
until about 30 weeks gestational age, when the fetal liver takes
over. As a result, infants born before 28 weeks of gestational age
have low levels of IGF-1, which is believed to result in the
failure of organs to grow and develop normally.
Following preterm birth, serum IGF-1 levels decrease rapidly and
remain low for the first weeks of life relative to corresponding
fetal levels in utero. Longitudinal studies report an association
between lower serum IGF-1 levels at birth in extremely preterm
infants and an increased risk of BPD, retinopathy of prematurity,
and neurodevelopmental and overall growth impairment. This provides
a rationale for evaluating OHB-607 to restore IGF-1 to levels that
would have been present in utero in a full-term pregnancy, to
potentially support the normal growth and development of the lung
and other organs2.
OHB-607 has the potential to be the first major respiratory
therapeutic breakthrough for extremely preterm infants since lung
surfactants were first approved more than 30 years ago.
About Bronchopulmonary Dysplasia (BPD3)
BPD is the most common complication of prematurity, resulting in
chronic lung disease affecting, on average, 40-50% of infants born
at less than 28 weeks of gestational age. Beyond BPD’s direct
impact on lung function, it can also lead to greater mortality,
increased hospitalization, and cost burden, as well as long-term
respiratory morbidity and neurodevelopment disability.
While the pathogenesis of BPD is multifactorial and not
completely understood, gestational age is the most significant
predictor of BPD and chronic lung disease following preterm birth.
Additional factors, including birth weight, growth restriction,
lung function, and gender, may also contribute to the severity of
BPD. Unfortunately, the care practices necessary to sustain life
after preterm birth result in direct and bystander injury to the
developing lung, particularly in infants requiring high levels of
oxygen therapy and invasive ventilation for extended periods.
OHB-607 has the potential to help the lung develop normally,
reducing the need for respiratory support, which could, in turn,
reduce the severity of BPD and its long-term outcomes.
About Oak Hill Bio
Oak Hill Bio Ltd is a clinical-stage neonatology and rare
disease therapeutics company developing life-changing medicines for
extremely preterm infants and patients suffering from rare
autoimmune diseases. The company, with operations in the United
States and the United Kingdom, is advancing a pipeline of six
promising clinical-stage and preclinical investigational
therapeutics. For more information, visit the company’s website at
www.oakhillbio.com.
About Chiesi Group
Chiesi is a research-oriented international biopharmaceutical
group that develops and markets innovative therapeutic solutions in
respiratory health, rare diseases, and specialty care. The
company’s mission is to improve people’s quality of life and act
responsibly towards both the community and the environment.
By changing its legal status to a Benefit Corporation in Italy,
the US, and France, Chiesi’s commitment to create shared value for
society as a whole is legally binding and central to company-wide
decision-making. As a certified B Corp since 2019, we’re part of a
global community of businesses that meet high standards of social
and environmental impact. The company aims to reach Net-Zero
greenhouse gas (GHG) emissions by 2035.
With over 85 years of experience, Chiesi is headquartered in
Parma (Italy), with 31 affiliates worldwide, and counts more than
7,000 employees. The Group’s research and development centre in
Parma works alongside 6 other important R&D hubs in France, the
US, Canada, China, the UK, and Sweden.
For further information please visit www.chiesi.com
1 Ley D, Hallberg B, Hansen-Pupp I, et al.
rhIGF-1/rhIGFBP-3 in Preterm Infants: A Phase 2 Randomized
Controlled Trial. J Pediatr. 2019;206:56-65.e8.
doi:10.1016/j.jpeds.2018.10.033 2 Kramer BW, Abman S, Daly M, et al. Insulin-like growth
factor-1 replacement therapy after extremely premature birth: An
opportunity to optimize lifelong lung health by preserving the
natural sequence of lung development. Paediatr Resp Rev 2023 May
6:S1526-0542(23)00020-9 3 Thébaud B, Goss KN, Laughon M, et al. Bronchopulmonary
dysplasia. Nat Rev Dis Primers. 2019 Nov 14;5(1):78
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Contacts for Media: Chiesi Group
Carla Arrieta Head of Global External Communications
& Media Relations +393408879754 mediarelations@chiesi.com
Gentry Lassiter Sr. Director Communications & Public
Affairs US Office +1 (888) 466-6505 x1549
us.mediarelations@chiesi.com
Oak Hill Bio Investors: Josh Distler Oak Hill Bio
Josh.distler@oakhillbio.com
Clinicians: Victoria Niklas Oak Hill Bio
Victoria.Niklas@oakhillbio.com
Media: Chris Railey Ten Bridge Communications
chris@tenbridgecommunications.com