FRANKLIN LAKES, NJ—Becton, Dickinson and Co. (BD) recently reported the publication of results from a 52-subject human clinical trial with the BD Libertas Wearable Injector. The study has been published in Clinical and Translational Science.
The subcutaneous (SC) drug delivery system, which is currently in the final phases of development, is designed as a ready-to-use delivery system for drugs such as biologics—with viscosities up to 50 cP—in 2-5 mL and 5-10 mL configurations. The clinical trial evaluated the performance of the 5 mL BD Libertas device in human subjects, including tissue effects, skin reactivity, and patient acceptance.
“The advantages of treating chronic conditions with SC administration are well-documented in literature and include reduced treatment time, cost and systemic effects with increased patient preference, autonomy and convenience. Wearable injectors should be intuitive, straightforward, and easy to use by patients and care-givers,” the authors reported.
The study results confirm that the BD Libertas device successfully delivered 5 mL of 8 cP injections to the abdomen and thigh, regardless of subject age, gender, or body-mass index, and with or without patient movement. The device only took 5.42 minutes to deliver a 5 mL 8 cP dose, according to the article.
“During half of the injections (1 thigh, 1 abdominal), a defined movement sequence had subjects walk 60 feet (18.3 meters), reach overhead (extension), bend forward (flexion), rotate side-to-side (trunk rotation) and lean side to side (lateral flexion) while standing,” the authors point out. “The movement sequence was complete within 3 minutes of WI [wearable injector] actuation.”
The application, use, and removal of the injector was found to be acceptable; 100 percent of subjects stated that they were likely to use the BD Libertas Wearable Injector if it was prescribed to them. No severe wheals, erythema, or bleeding were observed, and no unacceptable pain was noted at 24 hours post-injection.
As BD’s website notes, the Libertas injector uses BD’s Neopak primary container for compatibility between drug and delivery device. The device’s flow rate can also be customized, depending on the needs of the drug to be delivered, and it has built-in smart functionality, which enables connection to a healthcare network.
According to the study, “Although the wearable injector is designed as a prefilled system, for purposes of this study, injection solutions were prepared and injectors filled and assembled daily per a qualified aseptic process in the on-site clinic pharmacy. The injection solution was a non-crosslinked commercial hyaluronic acid (Vivacy Laboratories, Paris, France) diluted to 10% volume by volume in sterile 0.9% weight per volume physiological saline to reach a nominal viscosity of ~8cP (shear rate ~1000 s-1 at 20°C).”
This work represents the most recent in a series of more than 50 BD-conducted preclinical and clinical studies intended to inform the design and measure the performance of the wearable injector, as well as demonstrate the feasibility of 2 to 10 mL biologic injections into subcutaneous tissue and characterize tissue response to large volume injections in human and animal subjects.
“Wheal formation was observed post-injection at 63.9% of injection sites; 36.1% had none. The post-injection measurable wheals were graded as 24.9% very slight (volume mean 0.23cm3, SD 0.31), 28.3% well-defined (volume mean 1.60cm3, SD 0.95), or 10.7% moderate (volume mean 6.33cm3, SD 2.70),” as per the article. “Data trends per injection condition indicate wheal formation was more common in the thigh (84% with movement, 80% without) than the abdomen (41% with movement, 50% without). Within 1 hour of injection, the majority of sites had no measurable wheals (69.3%), with 20% very slight (volume mean 0.24cm3, SD 0.17) or 10.7% well-defined (volume mean 1.17 cm3, SD 0.72) wheals remaining.”
Pharmaceutical companies are now developing biologics for subcutaneous delivery in larger dose volumes (>2mL) to support life cycle management of therapies, including migration from intravenous to subcutaneous routes of administration. BD says the company recognized that limited clinical evidence existed in the public domain to support injection feasibility and tolerability with wearable injectors for larger dose volumes, and undertook this study.
“Similar studies across an extended range of viscosities would further probe WI [wearable injector] design efficacy, and extend the characterization of injector performance, tolerability, and acceptability,” the authors added. “However, all clinical data in the present study indicate promising potential for therapeutic applications of the spring-based investigational wearable injector.”
“These results show that BD Libertas Wearable Injector effectively delivers dose volumes up to 5 mL subcutaneously and may be leveraged by our pharmaceutical partners as a reliable platform for large volume delivery,” pointed out Eric Borin, worldwide president of BD Pharmaceutical Systems. “We are excited to share these results further with our partners and the broader market, to help accelerate and de-risk combination product development.”