BD (Becton, Dickinson and Company) has announced the initiation of the first pharma-sponsored combination product clinical trial using its BD Libertas™ Wearable Injector for subcutaneous delivery of complex biologics. This milestone represents a significant advancement in drug-device combination products that could transform how patients receive biologic therapies.
The selection of BD Libertas™ Wearable Injector for this pharma-sponsored trial follows successful outcomes from more than 50 BD-conducted pre-clinical and clinical studies. Notably, a device clinical study demonstrated excellent performance with 100% of study participants stating they would likely use the BD Libertas™ Wearable Injector if prescribed.
Clinical Trial Significance
The pharma-sponsored combination product clinical trial represents a significant advancement in accelerating innovation in drug-device combination products that provide greater flexibility for patients. The technology offers potential conversion from infused medications that require patients to travel to a hospital or clinic to more convenient patient care in various settings, including self-injection at home.
"This trial demonstrates BD's commitment to helping pharma companies by advancing large-volume injection science, ensuring therapies are accessible and patient friendly by offering more efficient and convenient options for biologics," said Patrick Jeukenne, worldwide president of BD Pharmaceutical Systems. "BD's enhanced testing capabilities acquired through ZebraSci and the proven capabilities of the BD Libertas™ Wearable Injector technology further position BD as an innovative leader in drug delivery."
Device Capabilities and Market Context
The BD Libertas™ Wearable Injector is an innovative, prefilled, patient ready-to-use drug delivery system designed to enable delivery of complex biologics via subcutaneous injection. The biologics market is expected to grow to more than $670 billion by 2030, and for pharmaceutical companies developing these complex drugs, the BD Libertas™ Wearable Injector offers a customizable, patient-centric solution.
The device features several key capabilities:
- Supports delivery of high-viscosity biologics up to 50 centipoise, enabling a wide range of subcutaneous therapies
- Offered in 2 to 5 mL and 5 to 10 mL configurations providing flexibility for diverse therapeutic requirements
- Features a fully mechanical, patient ready-to-use design with a simple "peel, stick and click" mechanism, requiring no end-user filling or assembly
Clinical Performance Data
An early feasibility clinical study of the investigational BD Libertas™ Wearable Injector evaluated 5ml, non-Newtonian ~8cP subcutaneous placebo injections in 52 healthy adult subjects for functionality, tissue effects, subject tolerability and acceptability. The study measured tissue effects from device removal post-injection through 24 hours, with the majority (>50%) of observed tissue effects resolved within 60 minutes and all within 24 hours.
Subject pain, measured on a 100mm Visual Analog Scale, peaked mid-injection at a mean of 9.1mm (SD 13.4) and rapidly resolved within 30 minutes to a mean of 0.4mm (SD 2.6). Subjects found their peak pain acceptable (≥90.2%) and injection site appearance acceptable (≥92.2%).
Manufacturing and Development Support
BD's ongoing validations of fill-finish and final assembly processes with multiple Contract Manufacturing Organizations enable the company to support pharmaceutical partners from development through commercial-scale production. The BD Libertas™ Wearable Injector is currently a product in development, intended as a device component for drug-device combination products and not subject to FDA 510(k) clearance or separate EU CE mark certification.
