This trial was the final stage of technical development for Intraject and provides evidence the technological and design issues that faced the system prior to Aradigm's acquisition of the Intraject technology have been solved.
Aradigm's advanced Intraject needle-free delivery technology has been developed to offer delivery solutions for liquid drug formulations. Current development programs focus on neurological disorders, heart disease, respiratory conditions and cancer.
The trial demonstrated acceptable performance and delivery consistency of the selected configuration in 194 healthy subjects who were each given multiple injections of saline via Intraject.
Out of the 1152 participants, 194 healthy subjects were given multiple injections of saline without any related adverse events or malfunctions, and with little to no pain. Subjects rated their injections as causing little or no pain sensation, a result in line with numerous other studies previously conducted with Intraject.
In addition, the majority of subjects that responded preferred the use of the Intraject device to a standard needle injection.
Intraject is comprised of two main parts: the glass capsule with a pre-filled volume of 0.5 ml, and a compact nitrogen gas power source ('the actuator'). The delivery process is completed in less than 60 milliseconds with less bruising and discomfort than may be encountered with syringes, pens or other devices.
Dr Bryan Lawlis, Chief Executive Officer of Aradigm said: "We have made progress with contract manufacturers towards process scale-up for registration and commercial manufacturing. This lets us initiate the partnering of the platform to companies for use with their drugs."
He fully expected to complete and announce the selection of a drug by the end of the year with the objective of commencing pivotal trials for regulatory submissions in the second half of next year.
The primary advantages of the Intraject Delivery System are the injection pressure profile is sufficient to deliver complete dose into subcutaneous space, but not so high as to penetrate into muscle. In addition no molecular changes (shearing) were observed following protein delivery in any of over 20 drugs tested.