Trial first to feature customisable delivery system
was specifically developed to optimise this device's performance,
marks a new advance in the customisation of drug development and
represents a new aerosol delivery platform technology.
Corus Pharma's latest clinical trial for a Cystic Fibrosis drug is the first to feature PARI's eFlow, a portable electronic nebuliser that features TouchSpray technology that uses a vibrating mesh to dictate particle size.
eFlow can produce aerosols with a high concentration of active ingredients, a defined droplet size, and a high proportion of respirable droplets in a shorter amount of time. Its silent mode of operation, small size (it can be held in one hand), lightweight, and battery use make this device user-friendly.
Corus claim that eFlow's advances give aztreonam lysinate for inhalation (AI) an approximate delivery time of less than three minutes as shown in Corus's Phase II trial. Currently other therapies using jet nebulisers take 15-20 minutes to deliver aerosolised antibiotic doses.
Corus is working closely with PARI Aerosol Research Institute to develop the inhalation formulation and deliver AI with eFlow.
Corus Pharma's Phase III trial for AI is a multi-centre, blinded, placebo-controlled trial conducted in 50 cystic fibrosis centres in the United States. It will evaluate the safety and efficacy of AI in patients with pulmonary Pseudomonas aeruginosa, bacteria that commonly infect the lungs of cystic fibrosis patients.
Aztreonam is an antibiotic that is currently approved in an intravenous form to treat a broad spectrum of gram-negative bacteria, including Pseudomonas aeruginosa. Inhaled delivery increases the concentration of the drug at the site of infection as compared to intravenous administration.
"Aztreonam lysinate for inhalation was an excellent opportunity for us to demonstrate our formulation and analytical expertise and to develop a stable and sterile product. This opportunity allowed the PARI Aerosol Research Institute to optimise the drug formulation to our advanced device and customise the eFlow platform for this application," said Dr Manfred Keller, director of PARI business unit Pharma.
Cystic fibrosis is a genetic disease affecting approximately 30,000 children and adults in the United States. One in 31 Americans (more than 10 million people) is an unknowing, symptomless carrier of the defective gene. CF causes the body to produce abnormally thick, sticky mucus that clogs the lungs, obstructs the pancreas, and leads to life-threatening lung infections.
According to the CF Foundation's National Patient Registry, the median age of survival for a person with CF is 33.4 years. As more advances have been made in the treatment of CF, the number of patients aging with CF has steadily grown. Today, nearly 40 per cent of the CF population is age 18 and older.
