BD (Becton, Dickinson and Company) has completed a 50-subject human clinical trial evaluating its BD Libertas Wearable Injector, marking a significant milestone in the development of this subcutaneous drug delivery system designed for biologics administration.
Clinical Trial Design and Objectives
The BD independently sponsored and conducted study was designed to evaluate the performance of the 5-mL BD Libertas device in human subjects, focusing on three key parameters: tissue effects, skin reactivity, and patient acceptance. The results from this clinical evaluation are expected to be announced in early 2020.
The award-winning injector is currently in development as a subcutaneous drug delivery system that requires no patient assembly and is capable of delivering biologics with viscosities up to 50 cP. The device is being developed in two configurations: 2-5 mL and 5-10 mL delivery volumes.
Comprehensive Development Program
This recent trial represents the most recent addition to an extensive research program, being part of a series of over 50 BD-conducted preclinical and clinical studies. These studies have been designed with multiple objectives: measuring the performance of the BD Libertas Wearable Injector, demonstrating the feasibility of 2-10 mL biologic injections into subcutaneous tissue, and characterizing tissue response to large volume injections in both human and animal subjects.
Strategic Impact on Biologics Delivery
Peter Nolan, Worldwide President of BD Pharmaceutical Systems, emphasized the company's commitment to pharmaceutical partnerships, stating, "BD is committed to bringing value to our pharma partnerships, including providing them with independent BD sponsored and generated study data to accelerate combination product development. The recent study reflects BD's continued investment in solutions to meet pharma's needs by expanding the design space for biologics delivery."
Technology Specifications
The BD Libertas Wearable Injector is engineered to address key challenges in biologics delivery, particularly for high-viscosity formulations. The device's capability to handle biologics with viscosities up to 50 cP positions it as a potential solution for delivering complex therapeutic proteins and monoclonal antibodies that traditionally require clinical administration due to their physical properties.
The system's design eliminates the need for patient assembly, potentially improving treatment adherence and reducing administration errors. The availability of both 2-5 mL and 5-10 mL configurations provides flexibility for different therapeutic applications and dosing requirements.
