Phase II Amount
$1,499,982
The greatest challenge with the protein therapeutic options in development for the treatment of COVID-19 is deployment. Currently these medicines require clinical infrastructure to deploy, are intravenously infused over hours, and have moderate to poor shelf-life stability. Elektrofis drug delivery technology (Elektroject), coupled with these therapeutics could obviate, in many cases, the need for clinical administration/infrastructure, alleviate logistics challenges with deployment, and enable administration in seconds. The Elektroject platform formulation technology promises these improvements by being designed to enable syringe-compatible, ultra-high concentrations (>400 mg/mL) with excellent stability. Elektrofis drug delivery-enabling technology has the ability to take these COVID protein therapeutics, and the majority of protein therapeutics out of the hospital and into the home or field. This DHA SBIR Phase II Sequential proposal aims to apply the Elektroject platform to a clinically relevant COVID antibody through the following objectives. Elektrofi will begin by further developing the Elektrofi platform (molecule-independent) CMC capabilities and nonclinical data, which can be used as a foundation to directly advance all of Elektrofis therapeutic programs. Subsequently, Elektrofi plans to engage regulators through the pre-IND process with a selected drug sponsor of a specified COVID antibody (CoVAb). With support from the sponsor and regulators regarding the planned work, Elektrofi aims to develop an Elektrofi formulation of the CoVAb and manufacture a batch for use in nonclinical study. As a whole, successful completion of this proposed work will substantially advance the Elektroject CoVAb on its way to the clinic by developing CMC and nonclinical support for the eventual IND-enabling data package. Additionally, this program will improve Elektrofis platform capabilities, which are expected to significantly advance the progress of Elektrofis subsequent and parallel therapeutic programs to the clinic.
