TUCSON, Ariz., Aug. 24, 2022 — Critical Path Institute (C-Path) today announced that Oak Hill Bio (Oak Hill), a clinical-stage neonatology and rare disease therapeutics company, has become a member of its International Neonatal Consortium (INC).
Oak Hill, launched in early 2022, is developing life-changing medicines for extremely preterm infants and patients affected by rare autoimmune diseases. C-Path’s INC is a global collaboration formed to forge a predictable regulatory path for evaluating the safety and effectiveness of therapies for neonates.
“The perspective and expertise Oak Hill brings to INC is invaluable, and we are thrilled to welcome them as members of the consortium,” said Kanwaljit Singh, M.D., M.P.H, INC Executive Director. “INC thrives thanks to a diverse group of stakeholders all working to bring life-altering medicines, and learn from each other’s research and data, to support infants in need.”
“As a neonatologist active in research, clinical care, and drug development for over twenty years, I have experienced the lack of progress and challenges in bringing new medicines to the NICU firsthand,” said Victoria Niklas, M.A., M.D., Chief Medical Officer at Oak Hill Bio. “We use medicines off-label to treat disease symptoms. Yet, developing medicines that target the mechanisms that underlie these diseases has been scarce.”
The product pipeline at Oak Hill includes two clinical-stage and four preclinical-stage programs. Its lead clinical-stage candidate is a proprietary human recombinant insulin-like growth factor 1 complexed with its main binding protein 3. Extremely premature infants develop critically low levels of this important growth factor after birth, potentially making them susceptible to complications of prematurity that are major determinants of poor short and long-term health outcomes. Oak Hill seeks to verify the results of a previous clinical study that replacing this factor reduces these complications, such as the development of severe bronchopulmonary dysplasia.
“Oak Hill Bio’s clinical-stage candidate has the potential to change the trajectory of the lifelong health of these fragile infants, and we are delighted to join with INC in their mission to drive better health for these newborns and their families through collaboration,” Niklas said.
INC accelerates the development of safe and effective therapies for neonates. The consortium engages the global neonatal community — families, neonatal nurses, academic scientists, regulators, pharmaceutical investigators, advocacy organizations and funders — to focus on the needs of the neonate. Through teams that share data, knowledge and expertise, INC advances medical innovation and regulatory science for this underserved population. To learn more about INC, please visit c-path.org/inc or contact us at email@example.com.
About Oak Hill Bio
Oak Hill Bio 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, which has operations in the United States and the United Kingdom, was launched to develop a pipeline of six promising clinical-stage and preclinical investigational therapeutics. For more information on Oak Hill Bio, visit the company’s website at www.oakhillbio.com.
About Critical Path Institute
Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands and C-Path Ltd. operates from Dublin, Ireland with additional staff in multiple other locations. For more information, visit c-path.org.
Critical Path Institute is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by non-government source(s), totaling $11,196,634. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.