US-based biotechnology firm Discovery Laboratories has completed patient enrolment in its Phase IIa dose expansion clinical trial to evaluate the administration of higher doses of its investigational drug / device product, Aerosurf, in premature infants 29 to 34 week gestational age (GA) with respiratory distress syndrome (RDS).
With the enrolment complete in this dose expansion trial, the company intends to start its Phase IIb trial of Aerosurf in the fourth quarter of this year beginning with premature infants 29 to 32 weeks GA.
The dose expansion trial is designed to expand upon the knowledge gained in the initial Phase IIa clinical trial.
The Phase IIa trial evaluated the safety and tolerability of a single exposure of three escalating inhaled doses of aerosolised KL4 surfactant to 48 premature infants 29 to 34 weeks GA receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone.
The company noted that the initial trial were met all key objectives, including establishment of proof of concept based on physiological data suggesting that aerosolised KL4 surfactant is being delivered into the lung of premature infants.
A total of 32 premature infants were enrolled in the multicentred, randomised, open-label, controlled Phase IIb dose expansion trial, which will evaluate the safety and tolerability of aerosolised KL4 surfactant administered in higher 60 and 90 minutes doses in premature infants 29 to 34 weeks.
In addition, the company continues to evaluate the physiological effects of aerosolised KL4 surfactant.
The company intends to release top-line results of the dose expansion trial in mid-November.
Discovery Labs chief development officer Steve Simonson said: "We are pleased to have achieved another milestone in our Aerosurf development programme with the completion of enrolment in the phase IIa expansion study and look forward to the start of our Aerosurf Phase IIb programme."
The company intends to start an Aerosurf Phase IIb trial in up to 250 premature infants 26 to 32 week GA in the fourth quarter of this year.
The Phase IIb trial is designed to evaluate two escalating doses of aerosolised KL4 surfactant with a primary purpose of showing evidence of efficacy.
If successful, the trial will inform the final design of a Phase III clinical programme.
Enrolment in the Phase IIb trial will start with premature infants 29 to 32 weeks GA and will then be followed by premature infants 26 to 28 weeks GA following completion of the Phase IIa programme in this age group.
The Phase IIb clinical trial is expected to be completed in mid next year.
Currently, the company is enrolling a 32-patient Phase IIa clinical trial to evaluate the safety and tolerability of escalating (30 and 45 minutes) and potentially repeat inhaled doses of aerosolised KL4 surfactant administered to premature infants 26 to 28 week GA.