Therabron Therapeutics Announces Favorable Infant Outcomes with Six-Month Follow-Up of a Phase 1b Recombinant Human CC10 Clinical Trial
Data Presented at the 2015 Hot Topics in Neonatology Medical Congress
ROCKVILLE, Md., Dec. 8, 2015 /PRNewswire/ -- Therabron Therapeutics, Inc., a specialty biotechnology company dedicated to advancing a new standard in respiratory care, today presented a retrospective analysis of long-term follow-up data from a phase 1b trial of recombinant human CC10 protein (rhCC10) in premature infants at risk for chronic respiratory morbidity (CRM). The data were presented at the Hot Topics in Neonatology Annual Meeting being held December 6-8, 2015 in Washington, D.C.
This clinical trial was double-blinded, randomized, and placebo-controlled, involving 24-29 week corrected age (CA), 600-1250 gram premature infants that were intubated to treat respiratory distress syndrome (RDS) and at risk for CRM. Twenty-two infants were enrolled in three treatment groups; placebo, 1.5-mg/kg rhCC10, and 5-mg/kg rhCC10. Infants received a single intratracheal dose in a constant volume of 2-mL/kg within four hours of the first dose of surfactant. Follow-up at six months corrected age (CA) was conducted in 17 of 20 surviving infants.
The data from this study suggest that a single dose of rhCC10 on the day of birth may have a clinically meaningful impact on infant's CRM risk. A reduced rate of both re-hospitalization from respiratory causes and the requirement for bronchodilator therapy was observed in rhCC10-treated infants compared to placebo controls. Zero of eleven infants in the combined rhCC10-treated groups required re-hospitalization for respiratory causes within the six-month period, while three of six infants in the placebo group were re-hospitalized in the same time period. Additionally, none of the 11 rhCC10-treated infants required bronchodilators through six months CA, while all but one of the placebo-treated infants did (p ≤ 0.05 for both observed outcomes).
"We are encouraged by the data generated to date in our CG100 clinical development program. While several therapeutics have been developed to address the acute needs of pre-term infants for viability, our product candidates have the potential to meaningfully impact the long-term respiratory sequelae of prematurity," said Dr. Aprile L. Pilon, Founder, Executive Vice President and CSO of Therabron. "rhCC10 has the potential to provide a significant respiratory health benefit for preterm infants following discharge from the neonatal intensive care unit."
Therabron's lead recombinant human CC10 protein product candidate (CG100), is a secretory protein that is believed to play an important protective role in the lung via maintenance of airway epithelia and is delivered by intratracheal instillation in intubated neonates. CG100 has the potential to improve long-term clinical outcomes in preterm infants and significantly reduce the economic burden beyond the infant's initial in-patient stay. Clinical study investigators previously reported suppression of inflammatory mediators in the respiratory tract and evidence of reduced lung injury in CG100 treated infants (Levine et al., Pediatric Research). This follow-on outcomes assessment suggests that the potential protective aspect of rhCC10 may persist well beyond the acute period, post-discharge.
Therabron is completing patient enrollment in a larger, phase 2 trial in preterm infants, with multiple data releases expected in 2016 and 2017. The ongoing phase 2 study is supported, in part, by a grant from the US FDA Office of Orphan Product Development.
About Chronic Respiratory Morbidities in Preterm Infants
Over half a million preterm infants are born in the US every year. Of those infants, about 60,000 are very low birth weight (VLBW) and experience respiratory distress; and up to 15 percent of this vulnerable patient population dies. Of those who survive, up to 15,000 will develop neonatal BPD, a chronic lung disorder that predisposes the child to potentially life-threatening respiratory infections and asthma. These infants typically experience repeated hospitalizations for respiratory complications, the need for numerous respiratory medications, and frequent doctor visits throughout their infancy and childhood. An estimated $26 billion are spent annually on medical care during the first year of life in these VLBW premature infants and the emotional cost of families impacted by having a child with this condition is substantial.
About Therabron Therapeutics, Inc.
Therabron Therapeutics, Inc. is a clinical-stage biotechnology company, founded in 2007 and located in Rockville, MD. Therabron is focused on the development of protein therapeutics to address respiratory disease. The company's product candidates aim to restore the natural immune balance in the lungs of respiratory patients through the administration of synthetic human CC10 proteins. The family of CC10 proteins, also known as secretoglobins, have the potential to change the course of acute and chronic respiratory diseases, representing large markets into which few truly novel drugs have been introduced. Therabron's product candidates have the potential to be first-in-class, disease-modifying, breakthrough biologic therapeutics. For additional information, please visit www.therabron.com.
SOURCE Therabron Therapeutics, Inc.
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