Premiplex (mecasermin rinfabate) / Takeda, Oak Hill Bio, Chiesi - LARVOL DELTA

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants (clinicaltrials.gov) - P2 | N=338 | Recruiting | Sponsor: OHB Neonatology Ltd. | Active, not recruiting ➔ Recruiting | Phase classification: P2b ➔ P2 | Trial completion date: Nov 2026 ➔ Jan 2028 | Trial primary completion date: Aug 2026 ➔ Jan 2026

Enrollment open • Phase classification • Trial completion date • Trial primary completion date • Bronchopulmonary Dysplasia • Hematological Disorders • Pulmonary Disease • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity

Chiesi Group and Oak Hill Bio announce License and Development Agreement to develop, manufacture, and commercialise OHB-607, a potentially transformative neonatal therapy (PRNewswire) - "Chiesi Farmaceutici S.p.A...and Oak Hill Bio...announced the execution of an agreement to develop, manufacture, and commercialise OHB-607, an investigational drug candidate being developed to treat complications of extremely premature birth....Chiesi and Oak Hill Bio intend to restart a Phase 2b clinical trial in 2024 in the United States, Europe, and Japan."

Licensing / partnership • New P2b trial • Bronchopulmonary Dysplasia

Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants (clinicaltrials.gov) - P=N/A | N=26 | Terminated | Sponsor: Oak Hill Bio Ltd | N=382 ➔ 26 | Trial completion date: Feb 2029 ➔ Aug 2022 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2029 ➔ Aug 2022; As the revised OHB-607-202 protocol extends the study's observational arm through 24 months corrective age (CA), the SHP607-203 protocol was terminated at 24 months CA.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Bronchopulmonary Dysplasia • Hematological Disorders • Pulmonary Disease • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Chronic Lung Disease in Extremely Premature Infants (clinicaltrials.gov) - P2b | N=338 | Active, not recruiting | Sponsor: OHB Neonatology Ltd. | N=81 ➔ 338 | Trial completion date: Feb 2025 ➔ Nov 2026 | Trial primary completion date: Feb 2025 ➔ Aug 2026

Enrollment change • Trial completion date • Trial primary completion date • Bronchopulmonary Dysplasia • Hematological Disorders • Pulmonary Disease • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity

PEDAL: Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP) (clinicaltrials.gov) - P2; N=76; Completed; Sponsor: Shire; Active, not recruiting ➔ Completed

Clinical • Trial completion • Retinal Disorders • Retinopathy of Prematurity

Development of Protein-Specific Analytical Methodologies to Evaluate Compatibility of Recombinant Human (rh)IGF-1/rhIGFBP-3 with Intravenous Medications Co-Administered to Neonates. (PubMed, J Pharm Sci) - "The protein complex of recombinant human insulin-like growth factor-1 and insulin‑like growth factor binding protein‑3 (rhIGF-1/rhIGFBP-3; mecasermin rinfabate), is an investigational product for the prevention of complications of prematurity...Methods developed for the rhIGF-1/rhIGFBP-3 admixtures, optimized in studies with furosemide, caffeine citrate and ampicillin, demonstrated good reproducibility, linearity, and limit of detection/quantitation...Furosemide was found to be physically incompatible with rhIGF-1/rhIGFBP-3. Our findings support the use of these methodologies for detection of protein modifications under various clinical administration conditions, and additionally supplement physical compatibility data studies of ultra-low concentrations of rhIGF-1/rhIGFBP-3 post co-administration to preterm infants with other medications (manuscript in-preparation)."

Journal • IGF1 • IGFBP3

A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature Infants (clinicaltrials.gov) - P2b; N=81; Active, not recruiting; Sponsor: Shire; Recruiting ➔ Active, not recruiting; N=477 ➔ 81

Clinical • Enrollment change • Enrollment closed • Bronchopulmonary Dysplasia • Hematological Disorders • Pulmonary Disease • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity • IGF1

PEDAL: Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP) (clinicaltrials.gov) - P2; N=76; Active, not recruiting; Sponsor: Shire; Phase classification: P=N/A ➔ P2; Trial completion date: May 2021 ➔ Sep 2021; Trial primary completion date: May 2021 ➔ Sep 2021

Phase classification • Trial completion date • Trial primary completion date • Retinal Disorders • Retinopathy of Prematurity

A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature Infants (clinicaltrials.gov) - P2b; N=600; Not yet recruiting; Sponsor: Shire; N=1053 ➔ 600; Trial completion date: Mar 2022 ➔ Feb 2023; Initiation date: Nov 2018 ➔ Mar 2019; Trial primary completion date: Mar 2022 ➔ Aug 2022

Clinical • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Bronchopulmonary Dysplasia • Hematological Disorders • Ophthalmology • Retinal Disorders • Retinopathy of Prematurity • IGF1 • IL7

A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature Infants (clinicaltrials.gov) - P2b; N=600; Recruiting; Sponsor: Shire; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Bronchopulmonary Dysplasia • Hematological Disorders • Ophthalmology • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity • IGF1 • IL7

A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature Infants (clinicaltrials.gov) - P2b; N=1053; Not yet recruiting; Sponsor: Shire; Initiation date: Dec 2017 ➔ Sep 2018

Clinical • Trial initiation date • Bronchopulmonary Dysplasia • Hematological Disorders • Ophthalmology • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity • IGF1 • IL7

A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature Infants (clinicaltrials.gov) - P2b; N=1053; Not yet recruiting; Sponsor: Shire

Clinical • New P2b trial • Bronchopulmonary Dysplasia • Hematological Disorders • Ophthalmology • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity • IGF1 • IL7

A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature Infants (clinicaltrials.gov) - P2b; N=477; Recruiting; Sponsor: Shire; Trial completion date: Feb 2023 ➔ Feb 2025; Trial primary completion date: Aug 2022 ➔ Feb 2025

Clinical • Trial completion date • Trial primary completion date • Bronchopulmonary Dysplasia • Hematological Disorders • Ophthalmology • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity • IGF1 • IL7

Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants (clinicaltrials.gov) - P=N/A; N=382; Recruiting; Sponsor: Shire; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Bronchopulmonary Dysplasia • Hematological Disorders • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity

Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants (clinicaltrials.gov) - P; N=382; Not yet recruiting; Sponsor: Shire

Clinical • New trial • Bronchopulmonary Dysplasia • Hematological Disorders • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity

IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Shire; Trial primary completion date: Jul 2015 ->Dec 2015

Trial primary completion date • Biosimilar

A study evaluating the safety and efficacy of an experimental drug for chronic lung disease against normally prescribed care in extremely premature babies (clinicaltrialsregister.eu) - P2; N=600; Sponsor: Premacure AB

Clinical • New P2 trial