- Design of the multi-center study is based on Phase 2a clinical
data, which showed a decrease in the occurrence of
severe bronchopulmonary dysplasia (BPD), a condition for which
there are no approved therapies.
- 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 to develop
OHB-607 under a license and development agreement.
CARY,
N.C., May 17, 2024 /PRNewswire/ -- 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
improving 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."
Diego Ardigò, Global research & Development Head at Chiesi
Group said "Within the fragility of extreme prematurity lies a
pressing need for action. With OHB-607, there is a chance to
provide the babies with what they lack due to their immaturity.
Addressing the medical needs of these infants goes beyond
scientific inquiry; it's a moral imperative to safeguard their
well-being."
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 US and shortly extend to Japan and 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
and retinopathy of prematurity. 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. A previous Phase 2a
study demonstrated a decrease in severe BPD and the feasibility of
OHB-607 infusion, supporting further investigation of OHB-607 for
the prevention of complications of prematurity.
About Bronchopulmonary Dysplasia (BPD)
BPD is the most common complication of prematurity, resulting in
chronic lung disease affecting 40-50% of infants born at less than
28 weeks of gestational age. BPD can lead to greater mortality,
increased hospitalization, and cost burden, as well as long-term
respiratory morbidity and neurodevelopment
disability.
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content:https://www.prnewswire.com/news-releases/oak-hill-bio-and-chiesi-group-announce-first-patient-enrolled-in-the-resumed-phase-2b-clinical-study-evaluating-ohb-607-for-the-prevention-of-bronchopulmonary-dysplasia-the-most-common-cause-of-chronic-lung-disease-in-premature-i-302148908.html
SOURCE Chiesi Group