PROVIDENCE – ProThera Biologics Inc. has been awarded a two-year $1.9 million Phase II grant from the National Institutes of Health to study the potential of a new test to assess prognosis of infants who have or might develop sepsis and necrotizing entercolitis, the company announced Wednesday.
The Small Business Innovation Research Fast Track grant will help the company develop a rapid bedside test that the company expects to be user-friendly, portable and suitable for use in a neonatal intensive care unit.
The company said the test involves the development of a biomarker to assess outcomes in neonates. It said there is currently no sensitive and specific test for early detection of neonatal sepsis or necrotizing entercolitis, both of which can result in shock and death within hours of clinical presentation.
The company will receive $1 million in year one of the grant and $862,493 in year two.
The company is developing a treatment for several acute inflammatory diseases through the use of anti-inflammatory, naturally occurring proteins in the blood called inter-alpha inhibitor proteins. ProThera said the level of anti-inflammatory proteins rapidly declines during acute illnesses and said it is trying to develop a replenishment strategy for patients.
The bedside test is expected to support the company’s development of the IAIP as a protein-replacement therapy.
The company received a $166,522 Phase I grant for the testing project in fiscal 2018, bringing the project’s total NIH funding for the project to $2.03 million.
“Detecting life-threatening, acute diseases at an early stage is a critical need for neonatal patients,” said Dr. James Padbury, one of the neontologists working with ProThera on the study. “So far, extremely promising results have been obtained with IAIP as a biomarker, and we look forward to further collaborating with ProThera.”
Padbury is the pediatrician-in-chief and chief of neonatal/perinatal medicine at Women & Infants Hospital and the Oh–Zopfi professor of pediatrics and perinatal research at the Warren Alpert School of Medicine at Brown University.
The company will also be working with Dr. Hala Chaaban and Dr. Birju Shah, assistant professors in pediatrics and neontologists at the University of Oklahoma College of Medicine.
“We are very excited to be working with Drs. Padbury, Chaaban and Shah on this critical program,” said Dr. Yow-Pin Lim, co-founder and CEO of ProThera Biologics, who serves as principal investigator on the project. “Their extensive knowledge of neonatal diseases is very important for the success of the program.”
Chris Bergenheim is the PBN web editor. You may reach him at Bergenheim@PBN.com.