US-based biotechnology firm Therabron Therapeutics has completed enrolment in its Phase ll clinical trial of CG100 to prevent chronic respiratory morbidity (CRM) in premature infants.
Currently under development, CG100 is a potential drug based on Therabron's recombinant human Club Cell 10 kDa Protein (rhCC10) for the prevention of chronic lung disease related to premature birth.
Therabron noted that out of more than four million infants born in the US each year, more than 10% are delivered prematurely, or before 37 weeks of gestation.
These infants naturally experience repeated hospitalisations for respiratory complications and experience constant coughing and wheezing.
CG100 is Therabron's intratracheal dosage form of rhCC10 and is expected to help protecting the lung through maintenance and repair of airway epithelia and modulation of inflammation in a large variety of respiratory diseases.
The multi-centre, randomised, double-blind, placebo-controlled, dose-escalation Phase ll trial has enrolled 88 preterm infants between 24-29 weeks gestational age who received positive pressure mechanical ventilation for the management of neonatal respiratory distress syndrome.
The trial continues to evaluate the safety and efficacy of a single intratracheal dose of CG100.
The primary endpoint of the trail is infant survival without CRM through 12 months, with specific objectives of the decline in respiratory re-hospitalisations, signs and symptoms of respiratory disease and unscheduled doctor's visits, as well as use of respiratory medications in CG100 treated infants in comparison with placebo.
By next year, the dataset of the trial, a portion of which is supported by the US FDA Office of Orphan Product Development, is scheduled to un-blind.
Therabron Therapeutics chief medical officer Dr Alan Cohen said: "Completion of enrolment in this Phase 2ll trial represents the achievement of a significant milestone for Therabron and an important step toward evolving the standard of care for preterm infants.
"To our knowledge, this is the first interventional Phase ll trial undertaken to address the issue of neonatal CRM, a condition for which there is substantial unmet medical need, considerable cost of care and currently no available therapeutic options.
"We look forward to completing patient follow-up, continued discussions with the FDA and other health agencies, and the prospect of advancing CG100 into Phase lll clinical development."