A spokesperson for Enable Injections told us its drug delivery system, enFuse, is considered a combination product by regulatory authorities, which means each therapeutic the drug delivery platform administers is a program developed alongside a pharmaceutical partner.
The agreement includes the potential for multiple molecule development programs and incorporates long-term manufacturing and supply arrangements.
Enable’s system is an on-body drug delivery platform with a drug transfer system compatible with standard syringes and vial container formats.
The spokesperson added that the ideal therapies to be delivered through the enFuse technology are those available intravenously, which then require a large volume when reformulated for subcutaneous delivery.
The wearable platform is being developed by Enable for subcutaneous administration of large-volumes ranging up to 50mL.
Small molecule therapies and biologics, like monoclonal antibodies, are capable of being delivered through the technology, the spokesperson confirmed.