Therabron Therapeutics Reaches 50 Percent Enrollment in Phase 2 Clinical Trial for Lead Pediatric Respiratory Critical Care Program

Company on Track to Complete Trial Enrollment by End of 2015

Jul 21, 2015, 09:17 ET from Therabron Therapeutics, Inc.

ROCKVILLE, Md., July 21, 2015 /PRNewswire/ -- Therabron Therapeutics, Inc., a specialty biotechnology company dedicated to redefining the management of respiratory disease through innovation, today announced that it has achieved over 50 percent patient enrollment in the second clinical trial evaluating its lead product candidate, CG100, for the prevention of chronic respiratory morbidities, including bronchopulmonary dysplasia (BPD), in premature infants. This phase 2a study is supported in part by a $1.6 M grant from the US FDA Office of Orphan Product Development.

"We are encouraged by the progress we have made with patient enrollment in this trial and the interest expressed by the neonatology community in our potentially transformative technology platform.  Importantly, our data and safety monitoring board has not observed any unexpected safety or tolerability concerns in the trial to date, allowing us to now proceed to the highest dosing group in this study," said Dr. Aprile L. Pilon, Founder, Chairman and CEO of Therabron Therapeutics.  "CG100 has the potential to provide a significant respiratory health benefit for very premature infants following discharge from the neonatal intensive care unit."

The CG100 product candidate is a recombinant human CC10 protein, a secretory protein that is believed to play an important protective role in the lung via maintenance of airway epithelia, 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.  In a previously completed clinical study (Levine et al., Peds Research, 2005; Therabron data on file), investigators observed suppression of inflammatory mediators in the respiratory tract and evidence of reduced lung injury in CG100 treated infants.  Additionally, infant hospitalizations due to respiratory causes, as well as the need for respiratory medications through six months post-discharge, were reduced in CG100 treated infants compared to controls.

Therabron anticipates completion of enrollment for the current trial by the end of 2015, with multiple data releases in expected in 2016.

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 advancement of respiratory therapeutics with disease-modifying potential. The company's product candidates aim to restore the natural immune balance in the lungs of respiratory patients through the administration of recombinant 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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